Back to resultsClostridium Difficile Vaccine Efficacy Trial (Clover)
Primary Purpose
Clostridium Difficile Infection
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Clostridium difficile vaccine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Clostridium Difficile Infection
Eligibility Criteria
Inclusion Criteria:
- Evidence of a personally signed and dated informed consent document.
- Willing and able to comply with study procedures.
- Subjects with an increased risk of future contact with healthcare systems or subjects who have received systemic antibiotics in the previous 12 weeks.
- Ability to be contacted by telephone during study participation.
- Negative urine pregnancy test for female subjects of childbearing potential.
Exclusion Criteria:
- Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
- Participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry until 1 month after the third vaccination.
- Previous administration of an investigational C difficile vaccine or C difficile mAb therapy.
- Prior episode of CDI..
- Receipt of blood products or immunoglobulins within 6 months before enrollment.
Subjects who may be unable to respond to vaccination due to:
- Metastatic malignancy; or
- End-stage renal disease; or
- Any serious medical disorder likely to be fatal within the next 12 months; or
- Congenital or acquired immunodeficiency; or
- Receipt of high dose systemic corticosteroids for 14 days within 28 days of enrollment; or
- Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months of enrollment.
- Known infection with human immunodeficiency virus (HIV).
- Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection.
- Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
- Prior small- or large-bowel resection.
- Any condition or treatment resulting in frequent diarrhea.
- Other acute or chronic condition or abnormality that may increase the risk associated with study participation or IP administration or may interfere with interpretation of study results
- Pregnant or breastfeeding female subjects; male subjects and female subjects who are sexually active and at risk for pregnancy and will not/cannot use 2 methods of contraception
Sites / Locations
- North Alabama Research Center, LLC
- Medical Affiliated Research Center, Inc.
- Coastal Clinical Research, LLC, An AMR Company
- The Pain Center of Arizona
- Phoenix VA Health Care System
- Phoenix Clinical LLC
- MedPharmics, LLC
- Hope Research Institute
- The Pain Center of Arizona
- Clinical Research Institute of Arizona, LLC
- Baptist Health Center for Clinical Research
- Baptist Health Rehabilitation Institute
- Arkansas Gastroenterology
- California Kidney Specialist
- Usborne Family Medicine
- Kaiser Permanente Daly City
- Premier Health Research Center, LLC
- Paradigm Clinical Research Centers, Inc.
- VA Loma Linda Healthcare System Research Pharmacy
- VA Loma Linda Healthcare System
- Long Beach Clinical Trials Services, Inc.
- Long Beach Clinical Trials
- VA Long Beach Healthcare System
- Academic Medical Research Institute
- Ronald Reagan UCLA Medical Center
- UCLA CTRC Outpatient Unit
- VA Northern California Health Care System
- Veterans Affairs Palo Alto Health Care System
- Covigilant Research, LLC
- Paradigm Clinical Research Centers, Inc.
- VA Loma Linda Healthcare System Ambulatory Care System
- Covigilant Research LLC
- Kaiser Permanente Roseville
- One Community Health
- Kaiser Permanente Sacramento
- CTSC Clinical Research Center
- Lawrence J. Ellison Ambulatory Care Center
- University of California, Davis Medical Center
- Kaiser Permanente South Sacramento
- Breakthrough Clinical Trials
- VA San Diego Healthcare System
- California Kidney Specialists
- Kaiser Permanente San Jose
- Kaiser Permanente Santa Clara
- Alta California Medical Group
- Kaiser Permanente Walnut Creek
- Clinical Trial Center University of Colorado Denver, School of Medicine
- University of Colorado Clinical & Translational Research Center Clinic
- University of Colorado Clinical & Translational Research Center Outpatient Clinic
- University of Colorado Denver, School of Medicine
- University of Colorado Department of AIP 2. Pharmacy Bulk Storage
- Gastroenterology Center of Connecticut, PC
- Medical Research Center of Connecticut, LLC
- Clinical Research Consulting, LLC
- Bay Pines VA Healthcare System
- Florida Sleep Disorder Center of Brandon
- Teradan Clinical Trials
- Southeast Clinical Research
- Innovative Research of West FL., Inc.
- Alliance for Multispecialty Reseach, LLC
- Omega Research Consultants, LLC
- Accel Research Sites - DeLand Clinical Research Unit
- Fleming Island Center for Clinical Research
- Malcom Randall VA Medical Center Investigational Drug Services
- Malcom Randall VA Medical Center
- Indago Research & Health Center, Inc
- Clinical Neuroscience Solutions,Inc.
- Multi-Specialty Research Associates, Inc.
- Charisma Medical and Research Center
- Ocean Blue Medical Research Center, Inc.
- Optimus U. Corp.
- Finlay Medical Research
- Doctors Research Institute
- Acevedo Clinical Research Associates
- Next Phase Research Alliance
- Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
- HMD Research LLC
- Pines Care Research Center, LLC
- Progressive Medical Research
- Precision Clinical Research, LLC
- Soma Medical Center
- Atlanta VA Medical Center
- Meridian Clinical Research
- Clinical Research Atlanta
- East-West Medical Research Institute
- Snake River Research, PLLC
- Advanced Clinical Research
- Solaris Clinical Research
- Christie Clinic, LLC
- Edward Hines Jr VA Hospital
- Springfield Clinic Infectious Diseases
- Community Clinical Research Center
- Infectious Disease of Indiana, PSC
- St. Vincent Outpatient Treatment Center
- Deaconess Clinic Mt. Pleasant
- St. Vincent Hospital & Health Care Center
- St. Vincent Hospital and Health Care Center
- MOC Research
- Meridian Clinical Research
- Alliance for Multispecialty Research, LLC
- Kentucky Pediatric/Adult Research
- Central Kentucky Research Associates, LLC
- Tandem Clinical Research, LLC
- MedPharmics, LLC
- Barnum Medical Research Inc
- Ochsner Center for Primary Care and Wellness
- Ochsner Clinic Foundation
- Luminis Health Anne Arundel Medical Center Infusion Center
- Luminis Health Anne Arundel Medical Center
- Luminis Health Research Institute: Research Office
- VA Ann Arbor Healthcare System
- ClinSite, LLC
- Aa Mrc Llc
- Revival Research Institute, LLC
- Mayo Clinic Rochester, Methodist Hospital Campus
- Mayo Clinic
- MedPharmics
- Center for Outpatient Health
- Washington University School of Medicine
- Barnes Jewish Hospital
- Barnes-Jewish Hospital
- Center for Advanced Medicine
- Center For Clinical Studies
- Sundance Clinical Research
- Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research
- Bozeman Health GI Clinic
- Mercury Street Medical Group, PLLC
- Meridian Clinical Research, LLC
- Barrett Clinic
- Meridian Clinical Research, LLC
- ID Care
- Amici Clinical Research
- South Jersey Infectious Disease
- New Mexico VA Healthcare System
- Meridian Clinical Research LLC
- Meridian Clinical Research, LLC
- Rochester Clinical Research
- PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
- PMG Research of Charlotte, LLC
- Durham VAMC
- Duke Early Phase Clinical Research
- Duke University Hospital Investigational Drug Services (IDS) Pharmacy
- PharmQuest
- PMG Research of Hickory, LLC
- PMG Research of Raleigh, LLC
- Wake Research Associates, LLC
- PMG Research of Rocky Mount, LLC
- PMG Research of Salisbury, LLC
- Waterway Primary Care LLC DBA Tabor City Family Medicine
- PMG Research of Wilmington, LLC
- PMG Research of Winston-Salem, LLC
- Progressive Medicine of the Triad, LLC
- Lillestol Research LLC
- Aultman Cardiology Clinical Trials
- Aultman Hospital
- UC Health Physicians Office Clifton
- University of Cincinnati Medical Center
- Sterling Research Group, Ltd.
- University Of Cincinnati-Internal Medicine Division of Digestive Diseases
- Louis Stokes Cleveland VA Medical Center
- University Hospitals Cleveland Medical Center
- Velocity Clinical Research, Inc.
- OhioHealth Riverside Methodist Hospital
- Riverside Methodist Hospital
- Remington-Davis, Incorporated
- PriMED Clinical Research
- Great Lakes Medical Research LLC
- IPS Research Company
- Kaiser Permanente Center For Health Research
- Columbia Research Group, Inc.
- VA Portland Healthcare System
- Lehigh Valley Health Network/Network Office of Research and Innovation
- Capital Area Research, LLC
- Westminster Family Medicine
- Liberty Family Practice
- Drexel University College of Medicine
- VA Pittsburgh Healthcare System
- Preferred Primary Care Physicians, Inc.
- Preferred Primary Care Physicians, Inc.
- Velocity Clinical Research, Providence
- Medical Research South, LLC
- Main Street Physician's Care - Waterway
- Coastal Carolina Research Center
- Holston Medical Group
- Internal Medicine and Pediatric Associates of Bristol, PC
- PMG Research of Bristol, LLC
- PMG Research, Inc. d/b/a PMG Research of Knoxville
- PMG Research,Inc. d/b/a PMG Research of Knoxville
- Clinical Neuroscience Solutions, Inc.
- Trinity Clinical Research
- Tekton Research, Inc.
- North Texas Infectious Diseases Consultants, P.A.
- Synexus US, LP
- Texas Health Care, PLLC
- Ventavia Research Group, LLC
- University of North Texas Health Science Center at Fort Worth
- University of Texas Medical Branch
- Kelsey Research Foundation
- Kelsey-Seybold Clinic
- Texas Center for Drug Development, Inc.
- Synexus US, dba Research Across America
- LinQ Research, LLC
- Clinical Trials of Texas, Inc.
- Diagnostics Research Group
- South Texas Veterans Healthcare System, Audie L Murphy Hospital
- DM Clinical Research
- Martin Diagnostic Clinic
- J. Lewis Research Inc. / Foothill Family Clinic Draper
- Advanced Clinical Research/Gut Whisperer
- J. Lewis Research, Inc./Foothill Family Clinic
- J Lewis Research, Incorporated
- J. Lewis Research, Inc. - Jordan River Family Medicine
- Clinical Alliance for Research & Education - Infectious Diseases, LLC
- Virginia Research Center LLC
- Salem VAMC
- Frandsen Family Medicine DBA Sound Medical Research
- MultiCare Institute for Research & Innovation
- Universal Research Group, LLC
- Wenatchee Valley Hospital & Clinics
- Marshfield Medical Center - Marshfield
- Hospital Aleman
- Hospital Italiano de Buenos Aires
- Centro Médico Dra. De Salvo
- Sanatorio Británico S.A.
- Hospital Nuestra Senora de la Misericordia
- Paratus Clinical Pty Ltd
- Australian Clinical Research Network
- Maroubra Medical Centre
- University Clinic Pharmacy
- Westmead Hospital
- Austrials Pty Ltd
- Mater Misericordiae Ltd & Mater Medical Research Institute Ltd
- Eastern Health - Box Hill Hospital
- Emeritus Research
- Barwon Health
- Linear Clinical Research
- Australian Clinical Research Network
- Institut Jules Bordet
- UZ Leuven
- CHU de Liège - Domaine universitaire du Sart Tilman
- "MHAT- Dr. Hristo Stambolski" EOOD
- MHAT ''Sv.Ivan Rilski-Kozloduy'' EOOD; Internal Department
- MHAT "Sv. Nikolay Chudotvorets" EOOD
- UMHAT "Dr. Georgi Stranski" EAD, Second Psychiatric Clinic of general psychiatry and dependence
- UMHAT "Sveti Georgi" EAD
- "Center for Mental Health - Ruse" EOOD
- SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD
- ''Medical Center-1-Sevlievo'' EOOD
- MHAT -Silistra AD
- MC ''Tsaritsa Yoanna''EOOD
- MC 'Cardiohelp' EOOD
- "Acibadem City Clinic University Hospital" EOOD
- Acibadem City Clinic Tokuda Ead
- MHAT "Sveta Anna - Sofia" AD, Clinic of Internal Diseases
- "SHATPD-Troyan" EOOD
- MC Medica Plus OOD
- MHAT ''Sveta Petka" AD
- Vancouver Coastal Health Research Institution-clinical research unit-Diamond Health Care Centre
- The Ottawa Hospital General Campus
- The Ottawa Hospital Civic Campus
- Manna Research Inc. (Toronto)
- Intermed Groupe Santé
- Q & T Research Outaouais Inc.
- Centre Integre de Sante et de Services Sociaux de la Monteregie- Center- Hopital Charles LeMoyne
- CIUSSS de l'Estrie - CHUS
- Centre Integre Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec
- Centre de recherche du CHU de Quebec-Universite Laval
- Centre de recherche Saint-Louis
- ALPHA Recherche Clinique
- Centro de Investigacion Clínica del Sur
- Psicomed Esudios Medicos
- Hospital Dr. Hernan Henriquez Aravena
- Biomedica Research Group
- Fundacion Arriaran
- Hospital Pablo Tobon Uribe
- Fundacion Centro de Investigacion Clinica - CIC
- Instituto de Coloproctologia ICO
- Clinica de la Costa Ltda.
- Asociación IPS Médicos Internistas de Caldas
- Centro de Investigaciones - MedPlus Centro de Recuperación Integral S.A.S.
- Fundación Cardiomet CEQUIN
- Fundacion Cardiovascular de Colombia
- Fundacion Valle del Lili
- Centro Medico Imbanaco de Cali S.A.
- Doktor Brno s.r.o.
- Ordinace vseobecneho praktickeho lekare
- Nemocnice Kyjov, prispevkova organizace, Infekcni oddeleni
- Slezska Nemocnice v Opave, prispevkova organizace
- Policska nemocnice s.r.o.,
- Fakultni nemocnice v Motole
- Oblastni nemocnice Pribram, a.s.
- Interna a kardiologie s.r.o.
- Nemocnice Slany, p.o.
- Sarkamed s.r.o.
- Krajska zdravotni, a.s., Masarykova nemocnice Usti nad Labem
- Helsinki University Central Hospital
- Kokkola Vaccine Research Clinic
- Oulu Vaccine Research Clinic
- Pori Vaccine Research Clinic
- Tampere Vaccine Research Clinic
- Turku Vaccine Research Clinic
- CHU DIJON BOURGOGNE- Hopital Francois Mitterrand
- CIC Vaccinologie Cochin- Pasteur 1417
- Hopital Nord-CHU Saint Etienne
- CHRU de Tours- Hopital Bretonneau
- Emovis GmbH
- MECS Cottbus GmbH
- Diabetologische Gemeinschaftspraxis Dr. Schaper & Dr. Faulmann
- Universitaetsklinikum Essen, Klinik fuer Infektiologie
- EUGASTRO GmbH/ Praxis
- SIBAmed Studienzentrum GmbH & Co.KG
- Gemeinschaftspraxis Dr. med. Heidrun Taeschner und Dr. med. Susanne Bonigut
- Universitaetsmedizin Rostock
- Praxis Dr. med. J. Springub/ W. Schwarz
- Studienzentrum Nordwest
- Klinikum Wuerzburg Mitte gGmbH
- Bajai Szent Rokus Korhaz, II Belgyogyaszat
- DRC Kft.
- Budapesti Szent Ferenc Korhaz, Kardiologiai Rehabilitacios Osztaly
- Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, I. Belgyogyaszati Osztaly
- Orszagos Koranyi Pulmonologiai Intezet, VI. Osztaly
- Semmelweis Egyetem III. Sz. Belgyogyaszati Klinika
- ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia
- CRU Hungary Kft.
- Somogy Megyei Kaposi Mor Oktato Korhaz, Infektologiai Osztaly
- Tokai Memorial Hospital
- Aichi Medical University Hospital
- Daido Clinic
- Kamiiida daiichi General Hospital
- Iizuka Hospital
- Seishinkai Inoue Hospital
- Fukuoka Tokushukai Hospital
- Kenwakai Otemachi Hospital
- Fukuyama City Hospital
- Miyanomori Memorial Hospital
- Medical Corporation Tokushukai Koga General Hospital
- Mito Kyodo General Hospital
- Yokosuka Kyosai Hospital
- Osaki Citizen Hospital
- Social Medical Care Corporation Hose-kai Marunouchi Hospital
- Nozaki Tokushukai Hospital
- Omi Medical Center
- Yaizu City Hospital
- Juntendo University Hospital
- Fukuwa Clinic
- Nerima General Hospital
- Sekino Hospital
- Fukui-Ken Saiseikai Hospital
- Japanese Red Cross Kumamoto Hospital
- Saga-Ken Medical Centre Koseikan
- Yonsei University Wonju Severance Christian Hospital
- Korea University Ansan Hospital
- Asan Medical Center
- Dong-A University Hospital
- Kyungpook National University Hospital
- The Catholic University of Korea, St. Vincent's Hospital
- Gachon University Gil Medical Center
- Inha University Hospital
- Korea University Anam Hospital
- Hallym University Kangdong Sacred Heart Hospital
- Samsung Medical Center
- Hallym University Kangnam Sacred Heart Hospital
- Korea University Guro Hospital
- Hospital Cayetano Heredia
- Hospital Nacional Adolfo Guevara Velasco
- Clinica Internacional S.A
- Centro de Investigaciones Biomédicas - CIBIOM/Clinica Peruano Americana S.A
- NZOZ Vitamed
- Synexus Polska Sp. z o.o Oddzial w Gdansku
- Synexus Polska Sp. z o.o. Oddzial w Gdyni
- SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach
- Niepubliczny Zaklad Opieki Zdrowotnej Salmed S. C.
- Synexus Polska Sp. z o.o. Oddział w Poznaniu
- Synexus Polska Sp. z o.o. Oddzial w Warszawie
- Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
- Hospital Garcia de Orta
- Centro Hospitalar do Baixo Vouga, E.P.E.
- Hospital de Braga
- Hospital Senhora de Oliveira - Guimaraes, E.P.E.
- Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
- PULMO-MEDIK s.r.o., Pneumologicko-ftizeologicka ambulancia
- Medak s.r.o., Gastroenterologicka ambulancia
- Stalerg, s.r.o.
- KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
- Dionea, s.r.o.
- MEDIPA, s.r.o.
- MUDr. Viliam Cibik, PhD, s.r.o.
- Medilex s.r.o., Interna ambulancia
- Plucna ambulancia Hrebenar s.r.o.
- SPAOLO s.r.o., Ambulancia vnutorneho lekarstva
- Privatna urologicka ambulancia, s.r.o.
- MUDr. Zakova, s.r.o.
- Fakutna nemocnica Trnava
- EAP Centelles
- Hospital Universitari de Bellvitge
- Complejo Hospitalario Universitario A Coruna
- Parc de Salut Mar- Hospital del Mar
- Hospital Clinic de Barcelona
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitario de la Princesa
- Hospital Universitario Gregorio Marañón
- Hospital Universitario Ramon y Cajal
- Hospital Universitario Fundacion Jimenez Diaz
- Hospital Universitario Virgen Macarena
- Hospital Universitari i Politecnic La Fe
- Infektionskliniken, Malarsjukhuset
- Sahlgrenska Universitetssjukhuset - Ostra Sjukhuset
- Gothia Forum CTC/Sahlgrenska Universitetssjukhuset
- Avdelningen for kliniska provningar, S-huset
- Karolinska Trial Alliance, KTA Prim Sabbatsbergs sjukhus
- Kaohsiung Veterans General Hospital
- Far Eastern Memorial Hospital
- National Taiwan University Hospital
- Stockport Nhs Foundation Trust
- Fowey River Practice
- Oak Tree Surgery
- The Alverton Practise, St Clare Medical Centre
- Rame Group Practice, Rame Medical Ltd.
- Royal Devon & Exeter Hospital
- Knowle House Surgery
- Layton Medical Centre
- University Hospitals of Leicester NHS Trust
- NHS Lothian, Western General Hospital
- Heart of England NHS Foundation Trust
- St James University Hospital
- Newcastle upon Tyne Hospitals NHS Foundation trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Clostridium difficile vaccine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of First Primary Episodes of Clostridium Difficile Infection (CDI) (Definition 1) Follow-up After Dose 3
CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by polymerase chain reaction [PCR)] and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Number of First Primary Episodes of Clostridium Difficile Infection (CDI) (Definition 1) Follow-up After Dose 2
CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 1
Local reactions included redness, swelling and pain at injection site. These were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 centimeter (cm) and graded as mild: 2.5 to 5.0 cm, moderate: greater than (>) 5.0 to 10.0 cm, severe: >10.0 cm. Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity. Grade 4 indicated emergency room visit or hospitalization.
Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 2
Local reactions included redness, swelling and pain at injection site. These were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm, severe: >10.0 cm. Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity. Grade 4 indicated emergency room visit or hospitalization.
Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 3
Local reactions included redness, swelling and pain at injection site. These were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm, severe: >10.0 cm. Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity. Grade 4 indicated emergency room visit or hospitalization.
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1
Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 degree Celsius [deg C]), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), potentially life threatening (> 40.0 deg C). Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock.
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 2
Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 deg C), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), potentially life threatening (> 40.0 deg C). Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock.
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 3
Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 deg C), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), potentially life threatening (> 40.0 deg C). Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock.
Number of Participants Reporting Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and all non-serious adverse events. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event. AEs included both SAEs and all Non-SAEs (except local and systemic events).
Number of Participants Reporting Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Secondary Outcome Measures
Number of All Episodes of CDI (Definition 1 and 2) After Dose 3
CDI definition 1 for primary episode of CDI (no previous CDI onset in prior 8 weeks) and CDI definition 2 for recurrent episode (episode occurred 8 weeks or less after onset of previous episode [provided symptoms of previous episode resolved]) were both defined as either a) presence of diarrhea, (passage of 3 or more unformed stools [Bristol stool chart types 5-7]) in 24 or fewer consecutive hours, stool sample positive for toxin B gene (by PCR),positive for toxin A and/or toxin B, as measured in central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, surgery, histopathologically; and corresponding stool sample positive for toxin B gene (via PCR) as measured in central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Time to Resolution for Participants With First Primary Episodes of CDI (Definition 1) After Dose 3
Resolution of the event was the last day on which the event was recorded in the e-diary or the date the event ends if it was unresolved during the participant diary-recording period (end date collected on the case report form [CRF]). CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Proportion of Participants Who Required Medical Attention During First Primary Episode of CDI (Definition 1) After Dose 3
CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Number of Participants With Recurrent Episodes of CDI (Definition 2) After Dose 3
CDI definition 2 for a recurrent episode (an episode of CDI that occurred 8 weeks or less after the onset of a previous CDI episode [provided the symptoms of the previous episode had resolved]), was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours; and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (by PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Number of All Episodes of CDI (Definition 1 and 2) After Dose 2
CDI definition 1 for primary episode of CDI (no previous CDI onset in prior 8 weeks) and CDI definition 2 for recurrent episode (episode occurred 8 weeks or less after onset of previous episode [provided symptoms of previous episode resolved]) were both defined as either a) presence of diarrhea, (passage of 3 or more unformed stools [Bristol stool chart types 5-7]) in 24 or fewer consecutive hours, stool sample positive for toxin B gene (by PCR),positive for toxin A and/or toxin B, as measured in central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, surgery, histopathologically; and corresponding stool sample positive for toxin B gene (via PCR) as measured in central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Number of Participants With Recurrent Episodes of CDI (Definition 2) After Dose 2
CDI definition 2 for a recurrent episode (an episode of CDI that occurred 8 weeks or less after the onset of a previous CDI episode [provided the symptoms of the previous episode had resolved]), was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours; and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (by PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Number of First Primary Episode of CDI (Definition 1) After Dose 2 and Before Dose 3
CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Number of Participants With Recurrent Episode of CDI (Definition 2) After Dose 2 and Before Dose 3
CDI definition 2 for a recurrent episode (an episode of CDI that occurred 8 weeks or less after the onset of a previous CDI episode [provided the symptoms of the previous episode had resolved]), was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours; and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (by PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03090191
Brief Title
Clostridium Difficile Vaccine Efficacy Trial
Acronym
Clover
Official Title
A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2017 (Actual)
Primary Completion Date
December 21, 2021 (Actual)
Study Completion Date
December 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated.
Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17535 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clostridium difficile vaccine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Clostridium difficile vaccine
Intervention Description
Toxoid-based Clostridium difficile vaccine
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Normal saline solution (0.9% sodium chloride)
Primary Outcome Measure Information:
Title
Number of First Primary Episodes of Clostridium Difficile Infection (CDI) (Definition 1) Follow-up After Dose 3
Description
CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by polymerase chain reaction [PCR)] and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Time Frame
From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
Title
Number of First Primary Episodes of Clostridium Difficile Infection (CDI) (Definition 1) Follow-up After Dose 2
Description
CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Time Frame
From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
Title
Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 1
Description
Local reactions included redness, swelling and pain at injection site. These were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 centimeter (cm) and graded as mild: 2.5 to 5.0 cm, moderate: greater than (>) 5.0 to 10.0 cm, severe: >10.0 cm. Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity. Grade 4 indicated emergency room visit or hospitalization.
Time Frame
Within 7 days after Dose 1 at Month 0
Title
Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 2
Description
Local reactions included redness, swelling and pain at injection site. These were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm, severe: >10.0 cm. Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity. Grade 4 indicated emergency room visit or hospitalization.
Time Frame
Within 7 days after Dose 2 at Month 1
Title
Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 3
Description
Local reactions included redness, swelling and pain at injection site. These were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm, severe: >10.0 cm. Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity. Grade 4 indicated emergency room visit or hospitalization.
Time Frame
Within 7 days after Dose 3 at Month 6
Title
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1
Description
Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 degree Celsius [deg C]), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), potentially life threatening (> 40.0 deg C). Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock.
Time Frame
Within 7 days after Dose 1 at Month 0
Title
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 2
Description
Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 deg C), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), potentially life threatening (> 40.0 deg C). Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock.
Time Frame
Within 7 days after Dose 2 at Month 1
Title
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 3
Description
Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 deg C), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), potentially life threatening (> 40.0 deg C). Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock.
Time Frame
Within 7 days after Dose 3 at Month 6
Title
Number of Participants Reporting Adverse Events (AEs)
Description
An AE was defined as any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and all non-serious adverse events. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event. AEs included both SAEs and all Non-SAEs (except local and systemic events).
Time Frame
From Day 1 of Dose 1 to 1 Month after Dose 3 (7 Months)
Title
Number of Participants Reporting Serious Adverse Events (SAEs)
Description
An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Time Frame
From Day 1 of Dose 1 up to 6 months after Dose 3 (up to Month 12)
Secondary Outcome Measure Information:
Title
Number of All Episodes of CDI (Definition 1 and 2) After Dose 3
Description
CDI definition 1 for primary episode of CDI (no previous CDI onset in prior 8 weeks) and CDI definition 2 for recurrent episode (episode occurred 8 weeks or less after onset of previous episode [provided symptoms of previous episode resolved]) were both defined as either a) presence of diarrhea, (passage of 3 or more unformed stools [Bristol stool chart types 5-7]) in 24 or fewer consecutive hours, stool sample positive for toxin B gene (by PCR),positive for toxin A and/or toxin B, as measured in central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, surgery, histopathologically; and corresponding stool sample positive for toxin B gene (via PCR) as measured in central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Time Frame
From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
Title
Time to Resolution for Participants With First Primary Episodes of CDI (Definition 1) After Dose 3
Description
Resolution of the event was the last day on which the event was recorded in the e-diary or the date the event ends if it was unresolved during the participant diary-recording period (end date collected on the case report form [CRF]). CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Time Frame
From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
Title
Proportion of Participants Who Required Medical Attention During First Primary Episode of CDI (Definition 1) After Dose 3
Description
CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Time Frame
From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
Title
Number of Participants With Recurrent Episodes of CDI (Definition 2) After Dose 3
Description
CDI definition 2 for a recurrent episode (an episode of CDI that occurred 8 weeks or less after the onset of a previous CDI episode [provided the symptoms of the previous episode had resolved]), was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours; and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (by PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Time Frame
From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
Title
Number of All Episodes of CDI (Definition 1 and 2) After Dose 2
Description
CDI definition 1 for primary episode of CDI (no previous CDI onset in prior 8 weeks) and CDI definition 2 for recurrent episode (episode occurred 8 weeks or less after onset of previous episode [provided symptoms of previous episode resolved]) were both defined as either a) presence of diarrhea, (passage of 3 or more unformed stools [Bristol stool chart types 5-7]) in 24 or fewer consecutive hours, stool sample positive for toxin B gene (by PCR),positive for toxin A and/or toxin B, as measured in central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, surgery, histopathologically; and corresponding stool sample positive for toxin B gene (via PCR) as measured in central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Time Frame
From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
Title
Number of Participants With Recurrent Episodes of CDI (Definition 2) After Dose 2
Description
CDI definition 2 for a recurrent episode (an episode of CDI that occurred 8 weeks or less after the onset of a previous CDI episode [provided the symptoms of the previous episode had resolved]), was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours; and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (by PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Time Frame
From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
Title
Number of First Primary Episode of CDI (Definition 1) After Dose 2 and Before Dose 3
Description
CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Time Frame
From 14 days after Dose 2 to Dose 3 or the day the third vaccination was expected (168 days after Dose 2) for participants who received only 2 doses
Title
Number of Participants With Recurrent Episode of CDI (Definition 2) After Dose 2 and Before Dose 3
Description
CDI definition 2 for a recurrent episode (an episode of CDI that occurred 8 weeks or less after the onset of a previous CDI episode [provided the symptoms of the previous episode had resolved]), was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours; and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (by PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
Time Frame
From 14 days after Dose 2 to Dose 3 or the day the third vaccination was expected (168 days after Dose 2) for participants who received only 2 doses
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Evidence of a personally signed and dated informed consent document.
Willing and able to comply with study procedures.
Subjects with an increased risk of future contact with healthcare systems or subjects who have received systemic antibiotics in the previous 12 weeks.
Ability to be contacted by telephone during study participation.
Negative urine pregnancy test for female subjects of childbearing potential.
Exclusion Criteria:
Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
Participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry until 1 month after the third vaccination.
Previous administration of an investigational C difficile vaccine or C difficile mAb therapy.
Prior episode of CDI..
Receipt of blood products or immunoglobulins within 6 months before enrollment.
Subjects who may be unable to respond to vaccination due to:
Metastatic malignancy; or
End-stage renal disease; or
Any serious medical disorder likely to be fatal within the next 12 months; or
Congenital or acquired immunodeficiency; or
Receipt of high dose systemic corticosteroids for 14 days within 28 days of enrollment; or
Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months of enrollment.
Known infection with human immunodeficiency virus (HIV).
Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection.
Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
Prior small- or large-bowel resection.
Any condition or treatment resulting in frequent diarrhea.
Other acute or chronic condition or abnormality that may increase the risk associated with study participation or IP administration or may interfere with interpretation of study results
Pregnant or breastfeeding female subjects; male subjects and female subjects who are sexually active and at risk for pregnancy and will not/cannot use 2 methods of contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
North Alabama Research Center, LLC
City
Athens
State/Province
Alabama
ZIP/Postal Code
35611
Country
United States
Facility Name
Medical Affiliated Research Center, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Coastal Clinical Research, LLC, An AMR Company
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
The Pain Center of Arizona
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Phoenix VA Health Care System
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Phoenix Clinical LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
MedPharmics, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
The Pain Center of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Clinical Research Institute of Arizona, LLC
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85374
Country
United States
Facility Name
Baptist Health Center for Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Baptist Health Rehabilitation Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
California Kidney Specialist
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
Usborne Family Medicine
City
Covina
State/Province
California
ZIP/Postal Code
91724
Country
United States
Facility Name
Kaiser Permanente Daly City
City
Daly City
State/Province
California
ZIP/Postal Code
94015
Country
United States
Facility Name
Premier Health Research Center, LLC
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Facility Name
Paradigm Clinical Research Centers, Inc.
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
VA Loma Linda Healthcare System Research Pharmacy
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
VA Loma Linda Healthcare System
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
Long Beach Clinical Trials Services, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Long Beach Clinical Trials
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Academic Medical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA CTRC Outpatient Unit
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
VA Northern California Health Care System
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States
Facility Name
Veterans Affairs Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Covigilant Research, LLC
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Paradigm Clinical Research Centers, Inc.
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
VA Loma Linda Healthcare System Ambulatory Care System
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Facility Name
Covigilant Research LLC
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Kaiser Permanente Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
One Community Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95811
Country
United States
Facility Name
Kaiser Permanente Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
CTSC Clinical Research Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Lawrence J. Ellison Ambulatory Care Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente South Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Breakthrough Clinical Trials
City
San Bernardino
State/Province
California
ZIP/Postal Code
92408
Country
United States
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
California Kidney Specialists
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
Kaiser Permanente San Jose
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Kaiser Permanente Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Alta California Medical Group
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Kaiser Permanente Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Clinical Trial Center University of Colorado Denver, School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Clinical & Translational Research Center Clinic
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Clinical & Translational Research Center Outpatient Clinic
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Denver, School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Department of AIP 2. Pharmacy Bulk Storage
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Gastroenterology Center of Connecticut, PC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Medical Research Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Clinical Research Consulting, LLC
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Bay Pines VA Healthcare System
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Facility Name
Florida Sleep Disorder Center of Brandon
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Teradan Clinical Trials
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Southeast Clinical Research
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
Facility Name
Innovative Research of West FL., Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Alliance for Multispecialty Reseach, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Omega Research Consultants, LLC
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Accel Research Sites - DeLand Clinical Research Unit
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Fleming Island Center for Clinical Research
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
Malcom Randall VA Medical Center Investigational Drug Services
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Malcom Randall VA Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Indago Research & Health Center, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Clinical Neuroscience Solutions,Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Multi-Specialty Research Associates, Inc.
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Charisma Medical and Research Center
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Ocean Blue Medical Research Center, Inc.
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Optimus U. Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Finlay Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Doctors Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Acevedo Clinical Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Next Phase Research Alliance
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
HMD Research LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Pines Care Research Center, LLC
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Precision Clinical Research, LLC
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Soma Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
Atlanta VA Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Meridian Clinical Research
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Snake River Research, PLLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Advanced Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Solaris Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Christie Clinic, LLC
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61822
Country
United States
Facility Name
Edward Hines Jr VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Springfield Clinic Infectious Diseases
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Community Clinical Research Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Infectious Disease of Indiana, PSC
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
St. Vincent Outpatient Treatment Center
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Deaconess Clinic Mt. Pleasant
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47725
Country
United States
Facility Name
St. Vincent Hospital & Health Care Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
St. Vincent Hospital and Health Care Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
MOC Research
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46544
Country
United States
Facility Name
Meridian Clinical Research
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51106
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Kentucky Pediatric/Adult Research
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Central Kentucky Research Associates, LLC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Tandem Clinical Research, LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
MedPharmics, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Barnum Medical Research Inc
City
Natchitoches
State/Province
Louisiana
ZIP/Postal Code
71457
Country
United States
Facility Name
Ochsner Center for Primary Care and Wellness
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Luminis Health Anne Arundel Medical Center Infusion Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Luminis Health Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Luminis Health Research Institute: Research Office
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
VA Ann Arbor Healthcare System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
ClinSite, LLC
City
Canton
State/Province
Michigan
ZIP/Postal Code
48187
Country
United States
Facility Name
Aa Mrc Llc
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Revival Research Institute, LLC
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48313
Country
United States
Facility Name
Mayo Clinic Rochester, Methodist Hospital Campus
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
MedPharmics
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Facility Name
Center for Outpatient Health
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1093
Country
United States
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Center for Advanced Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Center For Clinical Studies
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Sundance Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Bozeman Health GI Clinic
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Mercury Street Medical Group, PLLC
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Barrett Clinic
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68128
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
ID Care
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Amici Clinical Research
City
Raritan
State/Province
New Jersey
ZIP/Postal Code
08869
Country
United States
Facility Name
South Jersey Infectious Disease
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
New Mexico VA Healthcare System
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Meridian Clinical Research LLC
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Rochester Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
PMG Research of Charlotte, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Durham VAMC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Early Phase Clinical Research
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Duke University Hospital Investigational Drug Services (IDS) Pharmacy
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
PharmQuest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
PMG Research of Hickory, LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
PMG Research of Raleigh, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Rocky Mount, LLC
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
PMG Research of Salisbury, LLC
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Waterway Primary Care LLC DBA Tabor City Family Medicine
City
Tabor City
State/Province
North Carolina
ZIP/Postal Code
28463
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
PMG Research of Winston-Salem, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Progressive Medicine of the Triad, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Lillestol Research LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Aultman Cardiology Clinical Trials
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
UC Health Physicians Office Clifton
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Sterling Research Group, Ltd.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
University Of Cincinnati-Internal Medicine Division of Digestive Diseases
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Louis Stokes Cleveland VA Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Velocity Clinical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
OhioHealth Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Remington-Davis, Incorporated
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
PriMED Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
Great Lakes Medical Research LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Kaiser Permanente Center For Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Columbia Research Group, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
VA Portland Healthcare System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lehigh Valley Health Network/Network Office of Research and Innovation
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Capital Area Research, LLC
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Westminster Family Medicine
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
Liberty Family Practice
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16508
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Preferred Primary Care Physicians, Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Preferred Primary Care Physicians, Inc.
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Velocity Clinical Research, Providence
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Facility Name
Medical Research South, LLC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Main Street Physician's Care - Waterway
City
Little River
State/Province
South Carolina
ZIP/Postal Code
29566
Country
United States
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Holston Medical Group
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Internal Medicine and Pediatric Associates of Bristol, PC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
PMG Research of Bristol, LLC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
PMG Research, Inc. d/b/a PMG Research of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Facility Name
PMG Research,Inc. d/b/a PMG Research of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37938
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Trinity Clinical Research
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Facility Name
Tekton Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
North Texas Infectious Diseases Consultants, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Synexus US, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75324
Country
United States
Facility Name
Texas Health Care, PLLC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Ventavia Research Group, LLC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of North Texas Health Science Center at Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Kelsey Research Foundation
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Kelsey-Seybold Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Texas Center for Drug Development, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Synexus US, dba Research Across America
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
LinQ Research, LLC
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
South Texas Veterans Healthcare System, Audie L Murphy Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Martin Diagnostic Clinic
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
J. Lewis Research Inc. / Foothill Family Clinic Draper
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Advanced Clinical Research/Gut Whisperer
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
Facility Name
J. Lewis Research, Inc./Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J Lewis Research, Incorporated
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
J. Lewis Research, Inc. - Jordan River Family Medicine
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Clinical Alliance for Research & Education - Infectious Diseases, LLC
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Virginia Research Center LLC
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Salem VAMC
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Frandsen Family Medicine DBA Sound Medical Research
City
Port Orchard
State/Province
Washington
ZIP/Postal Code
98366
Country
United States
Facility Name
MultiCare Institute for Research & Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Universal Research Group, LLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Wenatchee Valley Hospital & Clinics
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Marshfield Medical Center - Marshfield
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Hospital Aleman
City
C.a.b.a.
State/Province
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
C.a.b.a.
State/Province
Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Centro Médico Dra. De Salvo
City
C.a.b.a.
State/Province
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Sanatorio Británico S.A.
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
S2000CVB
Country
Argentina
Facility Name
Hospital Nuestra Senora de la Misericordia
City
Cordoba
ZIP/Postal Code
X5000JRD
Country
Argentina
Facility Name
Paratus Clinical Pty Ltd
City
Kanwal
State/Province
New South Wales
ZIP/Postal Code
2259
Country
Australia
Facility Name
Australian Clinical Research Network
City
Maroiubra
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
Maroubra Medical Centre
City
Maroubra
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
University Clinic Pharmacy
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Austrials Pty Ltd
City
Sherwood
State/Province
Queensland
ZIP/Postal Code
4075
Country
Australia
Facility Name
Mater Misericordiae Ltd & Mater Medical Research Institute Ltd
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Eastern Health - Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Emeritus Research
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Barwon Health
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Linear Clinical Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Australian Clinical Research Network
City
Maroubra
ZIP/Postal Code
2035
Country
Australia
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Liège - Domaine universitaire du Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
"MHAT- Dr. Hristo Stambolski" EOOD
City
Kazanlak
ZIP/Postal Code
6100
Country
Bulgaria
Facility Name
MHAT ''Sv.Ivan Rilski-Kozloduy'' EOOD; Internal Department
City
Kozloduy
ZIP/Postal Code
3320
Country
Bulgaria
Facility Name
MHAT "Sv. Nikolay Chudotvorets" EOOD
City
Lom
ZIP/Postal Code
3600
Country
Bulgaria
Facility Name
UMHAT "Dr. Georgi Stranski" EAD, Second Psychiatric Clinic of general psychiatry and dependence
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMHAT "Sveti Georgi" EAD
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
"Center for Mental Health - Ruse" EOOD
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
Facility Name
SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
''Medical Center-1-Sevlievo'' EOOD
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
MHAT -Silistra AD
City
Silistra
ZIP/Postal Code
7500
Country
Bulgaria
Facility Name
MC ''Tsaritsa Yoanna''EOOD
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
MC 'Cardiohelp' EOOD
City
Sofia
ZIP/Postal Code
1142
Country
Bulgaria
Facility Name
"Acibadem City Clinic University Hospital" EOOD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Acibadem City Clinic Tokuda Ead
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
MHAT "Sveta Anna - Sofia" AD, Clinic of Internal Diseases
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Facility Name
"SHATPD-Troyan" EOOD
City
Troyan
ZIP/Postal Code
5600
Country
Bulgaria
Facility Name
MC Medica Plus OOD
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
MHAT ''Sveta Petka" AD
City
Vidin
ZIP/Postal Code
3700
Country
Bulgaria
Facility Name
Vancouver Coastal Health Research Institution-clinical research unit-Diamond Health Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
Facility Name
The Ottawa Hospital General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
The Ottawa Hospital Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Manna Research Inc. (Toronto)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W4L6
Country
Canada
Facility Name
Intermed Groupe Santé
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7Y8
Country
Canada
Facility Name
Q & T Research Outaouais Inc.
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 6S8
Country
Canada
Facility Name
Centre Integre de Sante et de Services Sociaux de la Monteregie- Center- Hopital Charles LeMoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
CIUSSS de l'Estrie - CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada
Facility Name
Centre Integre Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
Centre de recherche du CHU de Quebec-Universite Laval
City
Quebec
ZIP/Postal Code
G1E7G9
Country
Canada
Facility Name
Centre de recherche Saint-Louis
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
ALPHA Recherche Clinique
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Centro de Investigacion Clínica del Sur
City
Temuco
State/Province
IX Region DE LA Araucania
ZIP/Postal Code
4781156
Country
Chile
Facility Name
Psicomed Esudios Medicos
City
Antofagasta
State/Province
Region DE Antofagasta
ZIP/Postal Code
1270244
Country
Chile
Facility Name
Hospital Dr. Hernan Henriquez Aravena
City
Temuco
State/Province
Region DE LA Araucania
ZIP/Postal Code
4781151
Country
Chile
Facility Name
Biomedica Research Group
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Fundacion Arriaran
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8360159
Country
Chile
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050001
Country
Colombia
Facility Name
Fundacion Centro de Investigacion Clinica - CIC
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050021
Country
Colombia
Facility Name
Instituto de Coloproctologia ICO
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050025
Country
Colombia
Facility Name
Clinica de la Costa Ltda.
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Asociación IPS Médicos Internistas de Caldas
City
Manizales
State/Province
Caldas
ZIP/Postal Code
170004
Country
Colombia
Facility Name
Centro de Investigaciones - MedPlus Centro de Recuperación Integral S.A.S.
City
Bogota
State/Province
D.c.
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Fundación Cardiomet CEQUIN
City
Armenia
State/Province
Quindío
ZIP/Postal Code
630004
Country
Colombia
Facility Name
Fundacion Cardiovascular de Colombia
City
Floridablanca
State/Province
Santander
ZIP/Postal Code
681002
Country
Colombia
Facility Name
Fundacion Valle del Lili
City
Cali
State/Province
Valle DEL Cauca
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Centro Medico Imbanaco de Cali S.A.
City
Cali
State/Province
Valle DEL Cauca
ZIP/Postal Code
760043
Country
Colombia
Facility Name
Doktor Brno s.r.o.
City
Brno
State/Province
Czech
ZIP/Postal Code
65622
Country
Czechia
Facility Name
Ordinace vseobecneho praktickeho lekare
City
Benatky nad Jizerou
ZIP/Postal Code
29471
Country
Czechia
Facility Name
Nemocnice Kyjov, prispevkova organizace, Infekcni oddeleni
City
Kyjov
ZIP/Postal Code
697 01
Country
Czechia
Facility Name
Slezska Nemocnice v Opave, prispevkova organizace
City
Opava
ZIP/Postal Code
74601
Country
Czechia
Facility Name
Policska nemocnice s.r.o.,
City
Policka
ZIP/Postal Code
572 01
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Oblastni nemocnice Pribram, a.s.
City
Pribram I.
ZIP/Postal Code
26101
Country
Czechia
Facility Name
Interna a kardiologie s.r.o.
City
Roznov pod Radhostem
ZIP/Postal Code
756 61
Country
Czechia
Facility Name
Nemocnice Slany, p.o.
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
Sarkamed s.r.o.
City
Slany
ZIP/Postal Code
27401
Country
Czechia
Facility Name
Krajska zdravotni, a.s., Masarykova nemocnice Usti nad Labem
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029 HUS
Country
Finland
Facility Name
Kokkola Vaccine Research Clinic
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
Oulu Vaccine Research Clinic
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Pori Vaccine Research Clinic
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
Tampere Vaccine Research Clinic
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Turku Vaccine Research Clinic
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
CHU DIJON BOURGOGNE- Hopital Francois Mitterrand
City
Dijon cedex
ZIP/Postal Code
21079
Country
France
Facility Name
CIC Vaccinologie Cochin- Pasteur 1417
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Nord-CHU Saint Etienne
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
CHRU de Tours- Hopital Bretonneau
City
Tours Cedex 09
ZIP/Postal Code
37044
Country
France
Facility Name
Emovis GmbH
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
MECS Cottbus GmbH
City
Cottbus
ZIP/Postal Code
03050
Country
Germany
Facility Name
Diabetologische Gemeinschaftspraxis Dr. Schaper & Dr. Faulmann
City
Dresden
ZIP/Postal Code
01279
Country
Germany
Facility Name
Universitaetsklinikum Essen, Klinik fuer Infektiologie
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
EUGASTRO GmbH/ Praxis
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
SIBAmed Studienzentrum GmbH & Co.KG
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. med. Heidrun Taeschner und Dr. med. Susanne Bonigut
City
Leipzig
ZIP/Postal Code
04249
Country
Germany
Facility Name
Universitaetsmedizin Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Praxis Dr. med. J. Springub/ W. Schwarz
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Studienzentrum Nordwest
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Klinikum Wuerzburg Mitte gGmbH
City
Wuerzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Bajai Szent Rokus Korhaz, II Belgyogyaszat
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
DRC Kft.
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Budapesti Szent Ferenc Korhaz, Kardiologiai Rehabilitacios Osztaly
City
Budapest
ZIP/Postal Code
1021
Country
Hungary
Facility Name
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, I. Belgyogyaszati Osztaly
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Orszagos Koranyi Pulmonologiai Intezet, VI. Osztaly
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Semmelweis Egyetem III. Sz. Belgyogyaszati Klinika
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Facility Name
CRU Hungary Kft.
City
Encs
ZIP/Postal Code
3860
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz, Infektologiai Osztaly
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Tokai Memorial Hospital
City
Kasugai
State/Province
Aichi
ZIP/Postal Code
487-0031
Country
Japan
Facility Name
Aichi Medical University Hospital
City
Nagakute
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Daido Clinic
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Kamiiida daiichi General Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
462-0802
Country
Japan
Facility Name
Iizuka Hospital
City
Iizuka
State/Province
Fukuoka
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Seishinkai Inoue Hospital
City
Itoshima
State/Province
Fukuoka
ZIP/Postal Code
819-1104
Country
Japan
Facility Name
Fukuoka Tokushukai Hospital
City
Kasuga
State/Province
Fukuoka
ZIP/Postal Code
816-0864
Country
Japan
Facility Name
Kenwakai Otemachi Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
803-8543
Country
Japan
Facility Name
Fukuyama City Hospital
City
Fukuyama
State/Province
Hiroshima
ZIP/Postal Code
721-8511
Country
Japan
Facility Name
Miyanomori Memorial Hospital
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
064-8570
Country
Japan
Facility Name
Medical Corporation Tokushukai Koga General Hospital
City
Koga
State/Province
Ibaraki
ZIP/Postal Code
306-0041
Country
Japan
Facility Name
Mito Kyodo General Hospital
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
310-0015
Country
Japan
Facility Name
Yokosuka Kyosai Hospital
City
Yokosuka
State/Province
Kanagawa
ZIP/Postal Code
238-8558
Country
Japan
Facility Name
Osaki Citizen Hospital
City
Osaki
State/Province
Miyagi
ZIP/Postal Code
989-6183
Country
Japan
Facility Name
Social Medical Care Corporation Hose-kai Marunouchi Hospital
City
Matsumoto-City
State/Province
Nagano Prefecture
ZIP/Postal Code
390-8601
Country
Japan
Facility Name
Nozaki Tokushukai Hospital
City
Daito
State/Province
Osaka
ZIP/Postal Code
547-0074
Country
Japan
Facility Name
Omi Medical Center
City
Kusatsu
State/Province
Shiga
ZIP/Postal Code
525-8585
Country
Japan
Facility Name
Yaizu City Hospital
City
Yaizu
State/Province
Shizuoka
ZIP/Postal Code
425-8505
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Fukuwa Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Nerima General Hospital
City
Nerima-ku
State/Province
Tokyo
ZIP/Postal Code
176-8530
Country
Japan
Facility Name
Sekino Hospital
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
171-0014
Country
Japan
Facility Name
Fukui-Ken Saiseikai Hospital
City
Fukui
ZIP/Postal Code
918-8503
Country
Japan
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-8520
Country
Japan
Facility Name
Saga-Ken Medical Centre Koseikan
City
Saga
ZIP/Postal Code
840-8571
Country
Japan
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wonju-si
State/Province
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Ansan
State/Province
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Songpa-gu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Hallym University Kangdong Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
05355
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Hospital Cayetano Heredia
City
San Martin de Porres
State/Province
Lima
ZIP/Postal Code
31
Country
Peru
Facility Name
Hospital Nacional Adolfo Guevara Velasco
City
Cusco
ZIP/Postal Code
08002
Country
Peru
Facility Name
Clinica Internacional S.A
City
Lima
ZIP/Postal Code
41
Country
Peru
Facility Name
Centro de Investigaciones Biomédicas - CIBIOM/Clinica Peruano Americana S.A
City
Trujillo, La Libertad
ZIP/Postal Code
13011
Country
Peru
Facility Name
NZOZ Vitamed
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Synexus Polska Sp. z o.o Oddzial w Gdansku
City
Gdansk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdyni
City
Gdynia
ZIP/Postal Code
81-537
Country
Poland
Facility Name
SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Salmed S. C.
City
Leczna
ZIP/Postal Code
21-010
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddział w Poznaniu
City
Poznan
ZIP/Postal Code
60-702
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Warszawie
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-381
Country
Poland
Facility Name
Hospital Garcia de Orta
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Centro Hospitalar do Baixo Vouga, E.P.E.
City
Aveiro
ZIP/Postal Code
3814-501
Country
Portugal
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Hospital Senhora de Oliveira - Guimaraes, E.P.E.
City
Guimaraes
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
PULMO-MEDIK s.r.o., Pneumologicko-ftizeologicka ambulancia
City
Bojnice
ZIP/Postal Code
972 01
Country
Slovakia
Facility Name
Medak s.r.o., Gastroenterologicka ambulancia
City
Bratislava
ZIP/Postal Code
851 01
Country
Slovakia
Facility Name
Stalerg, s.r.o.
City
Kosice
ZIP/Postal Code
040 22
Country
Slovakia
Facility Name
KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Dionea, s.r.o.
City
Nove Zamky
ZIP/Postal Code
940 01
Country
Slovakia
Facility Name
MEDIPA, s.r.o.
City
Piestany
ZIP/Postal Code
921 01
Country
Slovakia
Facility Name
MUDr. Viliam Cibik, PhD, s.r.o.
City
Pruske
ZIP/Postal Code
01852
Country
Slovakia
Facility Name
Medilex s.r.o., Interna ambulancia
City
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
Plucna ambulancia Hrebenar s.r.o.
City
Spisska Nova Ves
ZIP/Postal Code
052 01
Country
Slovakia
Facility Name
SPAOLO s.r.o., Ambulancia vnutorneho lekarstva
City
Stara Tura
ZIP/Postal Code
916 01
Country
Slovakia
Facility Name
Privatna urologicka ambulancia, s.r.o.
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
Facility Name
MUDr. Zakova, s.r.o.
City
Trencin
ZIP/Postal Code
91101
Country
Slovakia
Facility Name
Fakutna nemocnica Trnava
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia
Facility Name
EAP Centelles
City
Centelles
State/Province
Barcelona
ZIP/Postal Code
08540
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruna
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Parc de Salut Mar- Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Infektionskliniken, Malarsjukhuset
City
Eskilstuna
ZIP/Postal Code
63188
Country
Sweden
Facility Name
Sahlgrenska Universitetssjukhuset - Ostra Sjukhuset
City
Goteborg
ZIP/Postal Code
41650
Country
Sweden
Facility Name
Gothia Forum CTC/Sahlgrenska Universitetssjukhuset
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Avdelningen for kliniska provningar, S-huset
City
Orebro
ZIP/Postal Code
70362
Country
Sweden
Facility Name
Karolinska Trial Alliance, KTA Prim Sabbatsbergs sjukhus
City
Stockholm
ZIP/Postal Code
11324
Country
Sweden
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung City
State/Province
Taiwan (r.o.c.)
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Stockport Nhs Foundation Trust
City
Stockport
State/Province
Cheshire
ZIP/Postal Code
SK27JE
Country
United Kingdom
Facility Name
Fowey River Practice
City
Fowey
State/Province
Cornwall
ZIP/Postal Code
PL23 1DT
Country
United Kingdom
Facility Name
Oak Tree Surgery
City
Liskeard
State/Province
Cornwall
ZIP/Postal Code
PL14 3XA
Country
United Kingdom
Facility Name
The Alverton Practise, St Clare Medical Centre
City
Penzance
State/Province
Cornwall
ZIP/Postal Code
TR183DX
Country
United Kingdom
Facility Name
Rame Group Practice, Rame Medical Ltd.
City
Torpoint
State/Province
Cornwall
ZIP/Postal Code
PL11 2TB
Country
United Kingdom
Facility Name
Royal Devon & Exeter Hospital
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Knowle House Surgery
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL5 3JB
Country
United Kingdom
Facility Name
Layton Medical Centre
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY3 7EN
Country
United Kingdom
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
NHS Lothian, Western General Hospital
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Heart of England NHS Foundation Trust
City
Birmingham
State/Province
WEST Midlands
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
St James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Newcastle upon Tyne Hospitals NHS Foundation trust
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B5091007
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Clostridium Difficile Vaccine Efficacy Trial
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