Back to resultsA Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
Primary Purpose
Pneumonia, Pneumococcal
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
V116
PCV15
PPSV23
Sponsored by
About this trial
This is an interventional prevention trial for Pneumonia, Pneumococcal
Eligibility Criteria
Inclusion Criteria:
- Has received pneumococcal vaccine >= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).
Exclusion Criteria:
- Has a history of invasive pneumococcal disease (IPD).
- Has a known hypersensitivity to any component of V116, PCV15, PCV20, or PPSV23, including diphtheria toxoid.
- Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease.
- Has a coagulation disorder contraindicating intramuscular vaccination.
- Has a known malignancy that is progressing or has required active treatment.
- Has received PPSV23 followed by either PCV15 or PCV20.
- Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day).
- Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease.
- Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine.
- Has received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine.
- Has received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 post-vaccination blood draw is complete.
Sites / Locations
- Central Research Associates ( Site 0024)
- Lenzmeier Family Medicine/CCT Research ( Site 0008)
- Fiel Family and Sports Medicine, PC/CCT Research ( Site 0006)
- Southland Clinical Research Center ( Site 0026)
- Diablo Clinical Research, Inc. ( Site 0019)
- Alliance for Multispecialty Research, LLC ( Site 0020)
- Indago Research & Health Center, Inc ( Site 0005)
- Advanced Medical Research Institute ( Site 0018)
- Solaris Clinical Research ( Site 0025)
- Centennial Medical Group ( Site 0002)
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0016)
- Meridian Clinical Research, LLC ( Site 0009)
- Advanced Medical Research ( Site 0001)
- University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si
- Health Research of Hampton Roads, Inc. ( Site 0003)
- Hamilton Medical Research Group ( Site 0114)
- Milestone Research Inc. ( Site 0104)
- Manna Research Mirabel ( Site 0109)
- CHU de Québec-Université Laval-Équipe de recherche en vaccination ( Site 0120)
- Diex Recherche Sherbrooke Inc. ( Site 0101)
- CHU Bordeaux Haut-Leveque ( Site 0202)
- CHRU de Brest ( Site 0200)
- centre hospitalier lyon sud ( Site 0204)
- Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0203)
- Rambam Health Care Campus ( Site 0303)
- Maccabi Health Services - Holon ( Site 0305)
- Maccabi Healthcare Services ( Site 0306)
- Hadassah Medical Center-Clinical Reaserch Unit ( Site 0300)
- Meir Medical Center ( Site 0301)
- Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0304)
- Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0302)
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0400)
- Ospedale San Raffaele ( Site 0403)
- A.O.U. Policlinico Paolo Giaccone ( Site 0402)
- Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 0405)
- PS Clinic ( Site 0700)
- Nishikumamoto Hospital ( Site 0701)
- Gachon University Gil Medical Center ( Site 0755)
- Korea University Ansan Hospital ( Site 0751)
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 0752)
- The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0753)
- Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 0754)
- Korea University Guro Hospital ( Site 0750)
- HOSPITAL CLÍNIC DE BARCELONA-Medicina Preventiva i Epidemiologia ( Site 0503)
- EBA CENTELLES ( Site 0500)
- Hospital Universitari de Bellvitge ( Site 0505)
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0508)
- Hospital Internacional Xanit ( Site 0520)
- Hospital La Princesa ( Site 0515)
- National Cheng Kung University Hospital ( Site 0801)
- National Taiwan University Hospital ( Site 0800)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Arm Label
Cohort 1: V116
Cohort 1: PCV15
Cohort 2: V116
Cohort 2: PPSV23
Cohort 3: V116
Arm Description
Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Participants will receive a single 0.5 mL IM injection of PCV15 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
Participants will receive a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV20, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
Outcomes
Primary Outcome Measures
Percentage of Participants with Solicited Injection-site Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited injection-site AEs include tenderness/injection-site pain, injection-site redness/injection-site erythema, and injection-site swelling/injection-site swelling.
Percentage of Participants with Solicited Systemic AEs
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The solicited systemic AEs include muscle aches all over body/myalgia, headache, and tiredness/fatigue.
Percentage of Participants with Vaccine-related Serious Adverse Events (SAEs)
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination will be summarized.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses
Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA).
Secondary Outcome Measures
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
The GMC of serotype-specific IgG for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using an pneumococcal electrochemiluminescence (Pn ECL) assay.
Geometric Mean Fold Rise (GMFR) of Serotype-specific OPA
Activity for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Geometric Mean Fold Rise (GMFR) of Serotype-specific IgG
Activity for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using an Pn ECL assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05420961
Brief Title
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
Official Title
A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
May 16, 2023 (Actual)
Study Completion Date
May 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.
Detailed Description
Participants will be randomized to 1 of 3 cohorts depending upon prior vaccinations. Prior vaccinations by cohort include: PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) for Cohort 1; PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) for Cohort 2; PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™), PCV20 (pneumococcal 20-valent conjugate vaccine; PREVNAR 20™), PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 for Cohort 3.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumococcal
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Cohorts 1 and 2: participants, investigator, sponsor Cohort 3: no blinding
Allocation
Randomized
Enrollment
717 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: V116
Arm Type
Experimental
Arm Description
Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Arm Title
Cohort 1: PCV15
Arm Type
Active Comparator
Arm Description
Participants will receive a single 0.5 mL IM injection of PCV15 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Arm Title
Cohort 2: V116
Arm Type
Experimental
Arm Description
Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
Arm Title
Cohort 2: PPSV23
Arm Type
Active Comparator
Arm Description
Participants will receive a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
Arm Title
Cohort 3: V116
Arm Type
Experimental
Arm Description
Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV20, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
Intervention Type
Biological
Intervention Name(s)
V116
Other Intervention Name(s)
Pneumococcal 21-valent Conjugate Vaccine
Intervention Description
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
Intervention Type
Biological
Intervention Name(s)
PCV15
Other Intervention Name(s)
VAXNEUVANCE™
Intervention Description
Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, and 4 μg of 6B in each 0.5 mL sterile solution
Intervention Type
Biological
Intervention Name(s)
PPSV23
Other Intervention Name(s)
PNEUMOVAX™23
Intervention Description
Pneumococcal 23-valent vaccine with 25 μg of each of the PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
Primary Outcome Measure Information:
Title
Percentage of Participants with Solicited Injection-site Adverse Events (AEs)
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited injection-site AEs include tenderness/injection-site pain, injection-site redness/injection-site erythema, and injection-site swelling/injection-site swelling.
Time Frame
Up to 5 days post-vaccination
Title
Percentage of Participants with Solicited Systemic AEs
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The solicited systemic AEs include muscle aches all over body/myalgia, headache, and tiredness/fatigue.
Time Frame
Up to 5 days post-vaccination
Title
Percentage of Participants with Vaccine-related Serious Adverse Events (SAEs)
Description
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination will be summarized.
Time Frame
Up to ~180 days
Title
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses
Description
Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA).
Time Frame
30 Days post-vaccination
Secondary Outcome Measure Information:
Title
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Description
The GMC of serotype-specific IgG for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using an pneumococcal electrochemiluminescence (Pn ECL) assay.
Time Frame
30 Days post-vaccination
Title
Geometric Mean Fold Rise (GMFR) of Serotype-specific OPA
Description
Activity for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Time Frame
Day 1 (Baseline) and 30 days post-vaccination
Title
Geometric Mean Fold Rise (GMFR) of Serotype-specific IgG
Description
Activity for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using an Pn ECL assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Time Frame
Baseline (Day 1) and 30 days post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Has received pneumococcal vaccine >= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).
Exclusion Criteria:
Has a history of invasive pneumococcal disease (IPD).
Has a known hypersensitivity to any component of V116, PCV15, PCV20, or PPSV23, including diphtheria toxoid.
Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease.
Has a coagulation disorder contraindicating intramuscular vaccination.
Has a known malignancy that is progressing or has required active treatment.
Has received PPSV23 followed by either PCV15 or PCV20.
Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day).
Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease.
Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine.
Has received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine.
Has received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 post-vaccination blood draw is complete.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Central Research Associates ( Site 0024)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Lenzmeier Family Medicine/CCT Research ( Site 0008)
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Fiel Family and Sports Medicine, PC/CCT Research ( Site 0006)
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Southland Clinical Research Center ( Site 0026)
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Diablo Clinical Research, Inc. ( Site 0019)
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC ( Site 0020)
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Indago Research & Health Center, Inc ( Site 0005)
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Advanced Medical Research Institute ( Site 0018)
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Solaris Clinical Research ( Site 0025)
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Centennial Medical Group ( Site 0002)
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0016)
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Meridian Clinical Research, LLC ( Site 0009)
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Advanced Medical Research ( Site 0001)
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Health Research of Hampton Roads, Inc. ( Site 0003)
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Hamilton Medical Research Group ( Site 0114)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
Milestone Research Inc. ( Site 0104)
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Manna Research Mirabel ( Site 0109)
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
CHU de Québec-Université Laval-Équipe de recherche en vaccination ( Site 0120)
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1E 7G9
Country
Canada
Facility Name
Diex Recherche Sherbrooke Inc. ( Site 0101)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
CHU Bordeaux Haut-Leveque ( Site 0202)
City
Pessac
State/Province
Aquitaine
ZIP/Postal Code
33600
Country
France
Facility Name
CHRU de Brest ( Site 0200)
City
Brest
State/Province
Finistere
ZIP/Postal Code
29609
Country
France
Facility Name
centre hospitalier lyon sud ( Site 0204)
City
Pierre-Bénite
State/Province
Rhone
ZIP/Postal Code
69310
Country
France
Facility Name
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0203)
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
Rambam Health Care Campus ( Site 0303)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Maccabi Health Services - Holon ( Site 0305)
City
Holon
Country
Israel
Facility Name
Maccabi Healthcare Services ( Site 0306)
City
Jerusalem
ZIP/Postal Code
71713
Country
Israel
Facility Name
Hadassah Medical Center-Clinical Reaserch Unit ( Site 0300)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center ( Site 0301)
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0304)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0302)
City
Sakhnin
ZIP/Postal Code
3081000
Country
Israel
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0400)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedale San Raffaele ( Site 0403)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
A.O.U. Policlinico Paolo Giaccone ( Site 0402)
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 0405)
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
PS Clinic ( Site 0700)
City
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan
Facility Name
Nishikumamoto Hospital ( Site 0701)
City
Kumamoto
ZIP/Postal Code
861-4157
Country
Japan
Facility Name
Gachon University Gil Medical Center ( Site 0755)
City
Namdong-gu
State/Province
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital ( Site 0751)
City
Ansan-si
State/Province
Kyonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 0752)
City
Seoul
ZIP/Postal Code
03312
Country
Korea, Republic of
Facility Name
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0753)
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 0754)
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital ( Site 0750)
City
Seoul
Country
Korea, Republic of
Facility Name
HOSPITAL CLÍNIC DE BARCELONA-Medicina Preventiva i Epidemiologia ( Site 0503)
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08036
Country
Spain
Facility Name
EBA CENTELLES ( Site 0500)
City
Centelles
State/Province
Cataluna
ZIP/Postal Code
08500
Country
Spain
Facility Name
Hospital Universitari de Bellvitge ( Site 0505)
City
L'Hospitalet de Llobregat
State/Province
Cataluna
ZIP/Postal Code
08907
Country
Spain
Facility Name
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0508)
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital Internacional Xanit ( Site 0520)
City
Benalmadena
State/Province
Malaga
ZIP/Postal Code
29630
Country
Spain
Facility Name
Hospital La Princesa ( Site 0515)
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
National Cheng Kung University Hospital ( Site 0801)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 0800)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
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