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A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

Primary Purpose

Respiratory Tract Infection

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RSVpreF
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Tract Infection focused on measuring Respiratory Tract infection, RSV, Vaccine, Maternal

Eligibility Criteria

0 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria - Maternal Participants:

  • Healthy women ≤49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Receiving prenatal standard of care based on country requirements.
  • Had a fetal anomaly ultrasound examination performed at ≥18 weeks of pregnancy with no significant fetal abnormalities observed.
  • Determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study.
  • Documented negative HIV antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization (Visit 1).
  • Intention to deliver at a hospital or birthing facility where study procedures can be obtained.
  • Expected to be available for the duration of the study and can be contacted by telephone during study participation.
  • Participant is willing to give informed consent for her infant to participate in the study.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol OR If the maternal participant is illiterate, a thumbprinted informed consent must be obtained, which must be signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant has been informed of all pertinent aspects of the study.

Inclusion Criteria -Infant Participants:

  • Evidence of a signed and dated ICD signed by the parent(s)/legal guardian(s) OR If the infant participant's maternal participant/parent(s)/legal guardian(s) is illiterate, a thumbprinted informed consent must have been obtained, which must have been signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant/parent(s)/legal guardian(s) has been informed of all pertinent aspects of the study for herself (maternal participant) and her fetus/infant prior to taking part in the study.
  • Parent(s)/legal guardian(s) willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria - Maternal Participants:

  • Prepregnancy body mass index (BMI) of >40 kg/m2. If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used.
  • Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any related vaccine.
  • Current pregnancy resulting from in vitro fertilization.

  • Current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and completion of the study, including but not limited to the following:

    • Preeclampsia, eclampsia, or uncontrolled gestational hypertension.
    • Placental abnormality.
    • Polyhydramnios or oligohydramnios.
    • Significant bleeding or blood clotting disorder.
    • Endocrine disorders, including untreated hyperthyroidism or untreated hypothyroidism. This also includes disorders of glucose intolerance (eg, diabetes mellitus type 1 or 2) antedating pregnancy or occurring during pregnancy if uncontrolled at the time of consent.
    • Any signs of premature labor with the current pregnancy or having ongoing intervention (medical/surgical) in the current pregnancy to prevent preterm birth.

  • Prior pregnancy complications or abnormalities at the time of consent, based on the investigator's judgment, that will increase the risk associated with the participation in and completion of the study, including but not limited to the following:

    • Prior preterm delivery ≤34 weeks' gestation.
    • Prior stillbirth or neonatal death.
    • Previous infant with a known genetic disorder or significant congenital anomaly.
  • Major illness of the maternal participant or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the maternal or infant participant's participation in, and completion of, the study or could preclude the evaluation of the maternal participant's response (includes positive serologic testing for regional endemic conditions assessed during routine maternal care, as per local standards of care and obstetric recommendations).
  • Congenital or acquired immunodeficiency disorder, or rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrollment.
  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Participation in other studies involving investigational drug(s) within 28 days prior to consent and/or during study participation.
  • Receipt of monoclonal antibodies within the year prior to enrollment or the use of systemic corticosteroids for >14 days within 28 days prior to study enrollment. Permitted treatments include the receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) monoclonal antibodies, prednisone doses of <20 mg/day for ≤14 days and, inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids.
  • Current alcohol abuse or illicit drug use. Note: Marijuana use is not considered an exclusion criterion for the study when elicited in participant screening, though it may be considered illicit in some locales.
  • Receipt of blood or plasma products or immunoglobulin (Ig), from 60 days before investigational product administration, or planned receipt through delivery, with 1 exception, Rho(D) immune globulin (eg, RhoGAM), which can be given at any time.
  • Previous vaccination with any licensed or investigational RSV vaccine or planned. Note: Licensed COVID-19 vaccines or COVID-19 vaccines authorized for temporary or emergency use will not be prohibited during the course of this study.
  • 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 Pfizer employees, including their family members, directly involved in the conduct of the study.
  • Participants who are breastfeeding at the time of enrollment.

Exclusion Criteria -Infant Participants:

o Infant who is a direct descendant (eg, child or grandchild) of the study personnel.

Sites / Locations

  • Central Research Associates, Inc.
  • Endocrinology and Internal Medicine Associates, PC
  • OB/GYN Associates of Alabama, PC
  • Sharp and Stone OB/GYN PC
  • St Vincent's Hospital
  • Children's of Alabama
  • UAB Women & Infants Center - UAB Medicine
  • University of Alabama at Birmingham/Center for Women's Reproductive Health
  • Cullman Clinical Research, Inc
  • Cullman Primary Care, PC
  • Cullman Regional
  • University of South Alabama Children's and Women's Hospital
  • USA Health Strada Patient Care Center
  • Springhill Medical Center
  • Velocity Clinical Research, Gulfport
  • Arrowhead Community Hospital
  • Banner Thunderbird Hospital
  • Abrazo West Campus Hospital
  • Velocity Clinical Research - Pheonix
  • Valleywise Comprehensive Health Center Women's Clinic
  • Valleywise Health Medical Center
  • St. Joseph's Hospital and Medical Center
  • MedPharmics, LLC
  • Velocity Clinical Research - Pheonix
  • Mesquite Pediatrics
  • Watching Over Mothers and Babies
  • Banner University Medical Center
  • University of Arizona
  • Banner University Medical Center ( North Campus )
  • St. Bernards Medical Center
  • St. Bernards OBGYN Associates
  • The Children's Clinic of Jonesboro, P.A.
  • The Children's Clinic of Jonesboro, PA
  • Century Research Institute
  • Chowchilla Medical Center
  • Loma Linda University Pediatric Clinic - Highland
  • Century Research Institute
  • Matrix Clinical Research
  • Chemidox Clinical Trials
  • Leonard S. Kurian, M.D., A Medical Corporation
  • Women & Infants Pavilion, Antelope Valley Hospital
  • Loma Linda University Adventist Health Sciences Center
  • Loma Linda University Faculty Medical Clinics
  • Loma Linda University Pediatric Clinics
  • Loma Linda Unversity Children's Hospital
  • Long Beach Clinical Trials
  • Long Beach Memorial Medical Center
  • St Mary Medical Center
  • Century Research Institute
  • Matrix Clinical Research..
  • East LA Doctors Hospital
  • Hollywood Presbyterian Medical Center
  • White Memorial Medical Center
  • Century Research Institute
  • Peter Morton Medical Building
  • Ronald Reagan UCLA Medical Center Drug Information Center Dept
  • Ronald Reagan University of California Los Angeles Medical Center
  • UCLA David Geffen School of Medicine
  • Affiliated Physician Practice
  • Charles E. Ugwu-Oju, M.D., F.A.C.O.G., Obstetrics & Gynecology
  • Madera Community Hospital
  • Madera Family Medical Group
  • Monterey Park Hospital
  • Lucile Packard Children's Hospital
  • Stanford University
  • Fomat- Raymond Poliakin, MD.
  • Carey Chronis, MD
  • Children's Hospital Colorado
  • University of Colorado Anschutz Inpatient Pavilion 2
  • University of Colorado AO1
  • University of Colorado Hospital Inpatient Pavilion
  • University of Colorado Hospital Outpatient Pavilion
  • University of Colorado Hospital
  • University of Colorado Leprino Building
  • University of Colorado Research II Building
  • Delta Memorial Hospital
  • Colorado Canyon's Hospital
  • Boeson Research
  • Dino-Peds
  • Women's Health Care of Western Colorado
  • Boeson Research
  • Community Hospital
  • SCL St. Mary's Medical Center
  • Montrose Memorial Hospital
  • Yale School Medicine Church Street Research Unit
  • Emerson Clinical Research Institute
  • Axcess Medical Research
  • North Shore Medical Center
  • Citadelle Clinical Research
  • A1 Imaging of Aventura
  • Rainbow Pediatrics
  • Baldwin Pediatrics
  • Emerald Coast Obstetrics and Gynecology
  • Emerald Coast Pediatrics
  • Gulf Coast Regional Medical Center
  • Rainbow Pediatrics
  • American Research Centers of Florida
  • Emory University Hospital Midtown
  • Emory Children's Center Illness POD
  • Emory Clinic
  • Emory University Investigational Drug Service
  • Emory University School of Medicine
  • Piedmont Columbus Regional Midtown
  • Columbus Regional Research Institute
  • 1st Choice Urgent Care & Family Medicine
  • Bingham Memorial Hospital
  • Elite Clinical Trials LLLP
  • Grove Creek Medical Center
  • ASR, LLC
  • Saint Alphonsus Regional Medical Center
  • St. Luke's Boise Medical Center
  • West Valley Medical Center
  • Clinical Research Prime
  • Eastern Idaho Regional Medical Center
  • Mountain View Hospital
  • The Pediatric Center
  • Saltzer Health
  • St. Luke's Meridian Medical Center
  • Saltzer Health
  • ASR, LLC
  • Saltzer Health
  • St. Alphonsus Medical Center- Nampa
  • St. Luke's Nampa Medical Center
  • Pocatello Women's Health Clinic
  • Portneuf Medical Center
  • 1st Choice Urgent Care
  • Clinical Research Prime Rexburg
  • Elite Clinical Trials LLLP
  • Madison Memorial Hospital
  • The Pediatric Center
  • Dupont Pediatrics
  • Women's Health Advantage
  • Mcfarland Clinic PC
  • Mary Greeley Medical Center
  • McFarland Clinic, P.C.
  • PMG Research of McFarland Clinic
  • The Iowa Clinic
  • Methodist West Hospital
  • The Iowa Clinic, P.C.
  • Alliance for Multispecialty Research, LLC
  • University of Kansas Medical Center
  • Alliance for Multispecialty Research, LLC
  • Owensboro Health Regional Hospital
  • Research Integrity, LLC
  • The Women's Pavillion, P.S.C
  • Alexandria Cardiology Clinic - Secondary Research Site
  • Cambridge Medical Trials - Main Research Site
  • Cambridge Medical Trials
  • Rabie Clinic for Women
  • Rapides Regional Medical Center Labor and Delivery
  • Lakeview Regional Medical Center
  • Medpharmics, LLC
  • St. Tammany Parish Hospital
  • Velocity Clinical Research
  • Ochsner Health Center - West Bank
  • North Oaks Medical Center
  • North Oaks Obstetrics & Gynecology
  • North Oaks Rural Health Clinic
  • MedPharmics LLC
  • Crescent City Physicians and Obstetrics
  • MedPharmics LLC
  • Ochsner Baptist Medical Center
  • Touro Infirmary
  • Ochsner Clinic Foundation
  • Ochsner Health Center for Children
  • Women Under Study, LLC
  • MedPharmics, LLC
  • Slidell Memorial Hospital
  • Boston Medical Center
  • Investigational Pharmacy Service
  • C.S. Mott Center
  • Hutzel-Harper Women's Hospital
  • University Health Center
  • Wayne State University Physician Group
  • Gulfport Memorial Hospital
  • MedPharmics, LLC
  • MedPharmics
  • Singing River Health System
  • Barnes Jewish Hospital
  • St. Louis Children's Hospital
  • Washington University School of Medicine
  • Baer Pediatrics
  • KDB Enterprises
  • Sundance Clinical Research, LLC
  • Boeson Research (BUT)
  • St James Healthcare
  • Benefis Health System
  • Boeson Research (GTF)
  • Origin Health GTF
  • Boeson Research (GTF)
  • Marcus Daly Memorial Hospital
  • Boeson Research (HLN)
  • St Peters Health
  • Boeson Reseach (KAL)
  • Kalispell Regional Medical Center
  • The Birth Center
  • Boeson Research LLC
  • Boeson Research
  • Community Medical Center
  • Community Physicians Group-Maternal Fetal Medicine
  • St Luke Community Clinic - Ronan
  • North Valley Hospital
  • Grand Island Regional Medical Center
  • CHI Health St. Francis
  • Grand Island Regional Medical Center
  • Meridian Clinical Research, LLC
  • Mary Lanning
  • Meridian Clinical Research
  • Midwest Children's Health Research Institute
  • Midwest Children's Health Research Institute.
  • Bryan Health
  • Midwest Childrens Health Research Institute
  • Women's Health Care Center of Williamsburg
  • Midwest Children's Health Research Institute
  • Meridian Clinical Research, LLC
  • Cooper University Hospital
  • Jaffe Family Womens Care Center
  • Pediatrics at Sheridan Pavilion- Three Cooper Plaza
  • Cooper Faculty OBGYN at Cherry Hill
  • Saint Peters University Hospital
  • Cooper Faculty OBGYN at Sewell
  • MedPharmics
  • Presbyterian Hospital
  • University of New Mexico Hospital
  • Velocity Clinical Research, Albuquerque
  • Lovelace Women's Hospital
  • New York Presbyterian of Queens Hospital
  • Theresa Lang Children's Ambulatory Center
  • Fresh Meadows Family Health Center
  • Hollis Women's Center
  • Jackson Heights Family Health Center
  • NYU Langone Hospital - Long Island
  • Women's Contemporary Care
  • Columbia Doctors
  • Audubon Clinic
  • Center for Prenatal Pediatrics
  • Columbia University Irving Medical Center
  • Herbert Irving Pavilion
  • Morgan Stanley Childrens Hospital
  • Meridian Clinical Research LLC
  • UNC OB/GYN at Panther Creek (recruitment, randomization, administration of IP)
  • UNC Children's Hospital (Pediatric follow up)
  • UNC Healthcare (recruitment, randomization, administration of IP)
  • UNC OB/GYN at Weaver Crossing (recruitment, randomization, administration of IP)
  • Duke Children's Primary Care - Roxboro Street
  • Duke Regional Hospital
  • Duke University.
  • Duke University Hospital
  • Womack Army Medical Center
  • FirstHealth Clinical Trials
  • FirstHealth Moore Regional Hospital
  • Sandhills Pediatrics
  • Sandhills Pediatrics
  • FirstHealth Southern Pines Women's Health Center
  • The Christ Hospital
  • University of Cincinnati Medical Center Department of Obstetrics and Gynecology
  • Cincinnati Children's Hospital Medical Center
  • Dayton Clinical Research
  • HWC Women's Research Center, LLC
  • UC Health West Chester Hospital
  • Integris Yukon Hospital
  • Tekton Research
  • Allegheny Health and Wellness Pavilion
  • OBGYN Associates of Erie
  • Liberty Family Practice
  • Saint Vincent Hospital
  • Reading Hospital - Children's Health Center
  • Reading Hospital - Women's Health Center
  • Reading Hospital-Family Health Care Center
  • Reading Hospital
  • Bon Secours St. Francis Hospital
  • Charleston 0B/GYN
  • Coastal Pediatric Research
  • Prisma Health-Upstate Office of Maternal Fetal Medicine
  • Prisma Health
  • Lowcountry Womens Specialists
  • Summerville Medical Center
  • Coastal Pediatric Research
  • Sanford Children's Specialty Clinic
  • Sanford Obstetrics and Gynecology Clinic (Recruitment, Consenting, IP Administration, and Follow Up)
  • Sanford Obstetrics and Gynecology Clinic
  • Sanford USD Medical Center (Main Hospital)
  • Sanford Women's Health Plaza (Recruitment, Consenting, and Follow Up)
  • Premier Medical Group
  • University of Tennessee Medical Center
  • Texas Health Arlington Memorial Hospital
  • Ventavia Research Group, LLC
  • Medical City Arlington (Women's Hospital)
  • St. David's Medical Center
  • Tekton Research, Inc.
  • Center for Women''s Health and Birthcare
  • Christus St. Elizabeth Hospital
  • Gadolin Research, LLC
  • Texas Health Harris Methodist Hospital Hurst-Euless-Bedford
  • Child Care Pediatrics, P.A.
  • Ventavia Research Group LLC
  • Texas Health Presbyterian Hospital Dallas
  • Ventavia Research Group LLC
  • Wise Health System Dectaur
  • Cline Pediatrics
  • Doctor's Hospital Womens Hospital
  • South Texas Health System- Edinburg
  • 8th Avenue Obstetrics & Gynecology
  • Baylor Scott & White All Saints Medical Center
  • Texas Health Harris Methodist Hospital Fort Worth
  • Ventavia Research Group, LLC
  • Texas Health Harris Methodist Hospital Southwest
  • University of Texas Medical Branch
  • Chisholm Trail Pediatrics
  • FMC Science
  • Georgetown OBGYN
  • St. David's Georgetown Hospital
  • Baylor Scott & White of Grapevine (Hospital)
  • Ventavia Research Group, LLC
  • Hany H. Ahmed, MD
  • HG Pediatrics
  • Van Tran Family Clinic
  • Ventavia Research Group, LLC
  • Memorial Hermann Memorial City
  • UT Health Women's Research Center at Memorial City
  • HCA: The Women's Hospital of Texas
  • Javara Inc.
  • Privia Medical Group Gulf Coast, PLLC
  • Texas Center for Drug Development, Inc
  • AdventHealth Family Medicine Rural Health Clinic, Inc.
  • FMC Science
  • Maximos Ob/Gyn
  • DCOL Center for Clinical Research
  • Diagnostic Clinic of Longview (Hollybrook)
  • Diagnostic Clinic of Longview (Medical Circle)
  • Longview Regional Medical Center
  • Rio Grande Regional Hospital
  • South Texas Health System- McAllen
  • Dr. Ruben Aleman and Associates
  • Medical City Plano
  • Texas Health Presbyterian Hospital Plano
  • Ventavia Research Group LLC
  • St. Luke's Baptist Hospital
  • Tekton Research, Inc.
  • DM Clinical Research
  • Medical City Weatherford
  • Ventavia Research Group
  • Alpine Medical Group
  • Intermountain Medical Center
  • JBR Clinical Research
  • Old Farm Obstetrics & Gynecology, LLC
  • Holladay Family Practice
  • St. Marks Hospital
  • University of Utah Hospital
  • University of Utah
  • Sentara Leigh Hospital
  • The Group for Women
  • Tidewater Physicians for Women
  • Clinical Research Partners, LLC
  • Virginia Commonwealth Univeristy Health Systems-Children's Pavilion
  • Virginia Commonwealth University Health System-Main Hospital
  • Virginia Commonwealth University Health System-Nelson Clinic
  • Clinical Research Partners, LLC
  • VCU Health Adult Outpatient Pavillion
  • Virginia Commonwealth University
  • Tidewater Physicians for Women
  • Seattle Children's Hospital
  • UW Neighborhood Ravenna Clinic
  • UW Neighborhood South Lake Union Clinic
  • University of Washington Medical Center - Northwest
  • UW Midwives Clinic at Northwest Outpatient Medical center
  • University of Washington Medical Center- Montlake
  • UW Neighborhood Shoreline Clinic
  • MultiCare Health System - Mary Bridge Children's Health Center
  • Multicare Health System-Multicare Women's Center Tacoma
  • Multicare Health System-Pediatrics Northwest
  • Multicare Health System-Tacoma General Hospital
  • MultiCare Institute for Research & Innovation
  • Cabell Huntington Hospital
  • Marshall Health
  • University Physicians and Surgeons dba Marshall Health Department of Obstetrics and Gynecology
  • University Physicians and Surgeons dba Marshall Health Department of Pediatrics
  • Marshfield Medical Center - Marshfield
  • Marshfield Medical Center
  • Clínica del Niño y la Madre
  • Hospital Italiano de Rosario
  • Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L
  • Instituto de Maternidad y Ginecologia: "Nuestra Senora de las Mercedes"
  • Sanatorio Mater Dei
  • Centro de Investigación Clinica OSECAC
  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
  • Hospital Publico Materno Infantil
  • Women's and Children's Hospital
  • Monash Children's Hospital
  • Barwon Health, University Hospital Geelong
  • Perth Children's Hospital
  • Telethon Kids Institute
  • St John of God Hospital Subiaco
  • Hospital Universitario/GAMP - Grupo de Apoio a Medicina Preventiva e a Saude Publica
  • Hospital Moinhos de Vento - HMV
  • Hospital Moinhos de Vento - HMV
  • Maternidade Darcy Vargas
  • Clinica de Alergia Martti Antila S/S Ltda./ CMPC - Consultoria Medica e Pesquisa Clinica
  • Canadian Center for Vaccinology - IWK Health Centre
  • CHU Sainte-Justine
  • CHU de Québec-Université Laval
  • Hospital Base San José de Osorno (Servicio de Obstetricia y Ginecología)
  • Centro de Capacitación e Investigaciones Clínicas (CCIC)
  • Clinica Universidad de los Andes
  • Satellite (Deliveries): Hospital San Juan de Dios (Maternidad)
  • Instituto de Investigaciones Materno Infantil (IDIMI)
  • Deliveries (satellite): Hospital San Jose
  • Grupo Estudios Clínicos Infectología Respiratoria
  • Deliveries (satellite): Hospital Clínico Universidad de Chile
  • Centro Internacional de Estudios Clinicos - CIEC
  • Hospital Padre Hurtado
  • Aarhus Universitetshospital
  • Nordsjællands Hospital
  • Hvidovre Hospital
  • Odense Universitets Hospital
  • FVR, Tampere Clinic
  • FVR, Oulu Clinic
  • MeVac
  • FVR, Kokkola Clinic
  • Kokkola Vaccine Research Clinic
  • FVR, Oulun rokotetutkimusklinikka
  • Oulu Vaccine Research Clinic
  • Tampereen yliopisto Oulun Rokotetutkimusklinikka
  • FVR, Pori Clinic
  • Pori Vaccine Research Clinic
  • Seinajoki Vaccine Research Clinic
  • Tampere Vaccine Research Clinic
  • FVR, Turku Clinic
  • Tampere University Vaccine Research Turku
  • Turku Vaccine Research Clinic
  • Medical Research Council Unit the Gambia at the London School of Hygiene & Tropical Medicine (LSHTM)
  • Fukui Aiiku Hospital
  • Hyogo Prefectural Amagasaki General Medical Center
  • Shonan Fujisawa Tokushukai Hospital
  • Rakuwakai Otowa Hospital
  • Kuwana City Medical Center
  • Sendai City Hospital
  • National Hospital Organization Beppu Medical Center
  • Social Medical Corporation KARIYUSHIKAI Heartlife Hospital
  • Osaka Habikino Medical Center
  • National Hospital Organization Tokyo Medical Center
  • Saitama City hospital
  • Shizuoka General Hospital
  • Chonnam National University Hospital
  • Seoul National University Hospital
  • Kyunghee University Hospital at Gangdong
  • Korea University Guro Hospital
  • Arke SMO S.A. de C.V.
  • Asociacion Mexicana para la Investigacion Clinica, A. C.
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Hospital General de Durango
  • Arke SMO S.A. de C.V.
  • Spaarne Gasthuis (Kennemer Gasthuis)
  • Diakonessenhuis Utrecht
  • University Medical Center Utrecht
  • Botany Downs Primary Birthing Unit
  • Papakura Primary Birthing Unit
  • Middlemore Hospital
  • Pukekohe Primary Birthing Unit
  • New Zealand Clinical Research (Christchurch)
  • Optimal Clinical Trials Ltd
  • Aotearoa Clinical Trials Trust (ACTT)
  • Middlemore Clinical Trials(Middlemore Hospital)
  • Christchurch Hospital (Canterbury District Health Board)
  • Capital, Coast and Hutt Valley District- Wellington Regional Hospital
  • Wellington Hospital (Capital and Coast District Health Board)
  • Asian Hospital and Medical Center
  • JOSHA Research
  • Wits RHI Shandukani Research Centre
  • Into Research, West Wing Medical Centre
  • Setshaba Research Centre
  • University of the Witwatersrand Vaccines & Infectious Diseases Analytics (VIDA)
  • Limpopo Clinical Research Initiative
  • MRC Unit on Child and Adolescent Health
  • Khayelitsha Satellite Site: Michael Mapongwana Community Health Centre
  • FAMCRU, University of Stellenbosch, Paediatric
  • Kraaifontein Satellite site
  • University of the Witwatersrand Vaccines & Infectious Diseases Analytics (VIDA)
  • Worcester Satellite site
  • CHUS - Hospital Clinico Universitario
  • Hospital de Antequera
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Madrid Puerta del Sur Mostoles
  • Hospital Universitari i Politecnic La Fe
  • Hsinchu Mackay Memorial Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Mackay Memorial Hospital
  • National Taiwan University Hospital
  • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RSVpreF vaccine

Placebo dose

Arm Description

RSVpreF

Placebo

Outcomes

Primary Outcome Measures

The percentage reduction in the incidence of medically attended LRTI (MA-LRTI) due to RSV in infants through 180 days of life
The percentage relative risk reduction in the incidence of MA-LRTI due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants
The percentage reduction in the incidence of medically attended severe LRTI due to RSV in infants through 180 days of life
The percentage relative risk reduction in the incidence of severe MA-LRTI due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants
The percentage of infant participants with specific birth outcomes
Describe specific birth outcomes for infant participants
The percentage of infant participants with adverse events (AEs) from birth to 1 month of age
Describe AE for infant participants from birth to 1 month of age
The percentage of infant participants with serious adverse events (SAE) and newly diagnosed chronic medical conditions (NDCMCs) from birth to 12 months of age
Describe SAE and NDCMCs for infant participants from birth to 12 months of age
The percentage of infant participants with serious adverse events (SAE) and newly diagnosed chronic medical conditions (NDCMCs) from birth to 24 months of age
Describe SAE and NDCMCs for infant participants from birth to 24 months of age
Percentage of maternal participants reporting local reactions and systemic events from day of vaccination (Day 1) until Day 7
Describe local reactions and systemic events after vaccination
Percentage of maternal participants reporting Adverse Events (AE) within 1 month after vaccination
Describe adverse events (AE) after vaccination
Percentage of maternal participants reporting SAEs
Describe serious adverse events from enrolment up to 180 days after delivery

Secondary Outcome Measures

The percentage reduction in the incidence of hospitalizations due to RSV in infants through 360 days of life
The percentage relative risk reduction in the incidence of hospitalization due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants
The percentage reduction in the incidence of all-cause MA-LRTI in infant participants
The percentage relative risk reduction in the incidence of all-cause MA-LRTI in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants
The percentage reduction in the incidence of MA-LRTI due to RSV in infants participants
The percentage relative risk reduction in the incidence of MA-LRTI due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants

Full Information

First Posted
June 3, 2020
Last Updated
September 26, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04424316
Brief Title
A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
Official Title
A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

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
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.
Detailed Description
This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy, safety, and immunogenicity of RSVpreF or placebo (1:1 randomization) in infants born to healthy women vaccinated during pregnancy, as well as the safety and immunogenicity in the pregnant women. This will be a global study which will span multiple RSV seasons.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infection
Keywords
Respiratory Tract infection, RSV, Vaccine, Maternal

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This is a double-blinded, placebo-controlled study.
Allocation
Randomized
Enrollment
14763 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RSVpreF vaccine
Arm Type
Experimental
Arm Description
RSVpreF
Arm Title
Placebo dose
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
RSVpreF
Intervention Description
RSV vaccine (RSVpreF)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
The percentage reduction in the incidence of medically attended LRTI (MA-LRTI) due to RSV in infants through 180 days of life
Description
The percentage relative risk reduction in the incidence of MA-LRTI due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants
Time Frame
Delivery to 180 days after delivery
Title
The percentage reduction in the incidence of medically attended severe LRTI due to RSV in infants through 180 days of life
Description
The percentage relative risk reduction in the incidence of severe MA-LRTI due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants
Time Frame
Delivery to 180 days after delivery
Title
The percentage of infant participants with specific birth outcomes
Description
Describe specific birth outcomes for infant participants
Time Frame
Birth
Title
The percentage of infant participants with adverse events (AEs) from birth to 1 month of age
Description
Describe AE for infant participants from birth to 1 month of age
Time Frame
Up to 1 month of age
Title
The percentage of infant participants with serious adverse events (SAE) and newly diagnosed chronic medical conditions (NDCMCs) from birth to 12 months of age
Description
Describe SAE and NDCMCs for infant participants from birth to 12 months of age
Time Frame
From birth up to 12 months of age
Title
The percentage of infant participants with serious adverse events (SAE) and newly diagnosed chronic medical conditions (NDCMCs) from birth to 24 months of age
Description
Describe SAE and NDCMCs for infant participants from birth to 24 months of age
Time Frame
From birth up to 24 months of age
Title
Percentage of maternal participants reporting local reactions and systemic events from day of vaccination (Day 1) until Day 7
Description
Describe local reactions and systemic events after vaccination
Time Frame
From day of vaccination until 7 days after vaccination
Title
Percentage of maternal participants reporting Adverse Events (AE) within 1 month after vaccination
Description
Describe adverse events (AE) after vaccination
Time Frame
Within 1 month after vaccination
Title
Percentage of maternal participants reporting SAEs
Description
Describe serious adverse events from enrolment up to 180 days after delivery
Time Frame
From enrollment up to 180 days after delivery
Secondary Outcome Measure Information:
Title
The percentage reduction in the incidence of hospitalizations due to RSV in infants through 360 days of life
Description
The percentage relative risk reduction in the incidence of hospitalization due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants
Time Frame
Delivery to 360 days after delivery
Title
The percentage reduction in the incidence of all-cause MA-LRTI in infant participants
Description
The percentage relative risk reduction in the incidence of all-cause MA-LRTI in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants
Time Frame
Delivery to 360 days after delivery
Title
The percentage reduction in the incidence of MA-LRTI due to RSV in infants participants
Description
The percentage relative risk reduction in the incidence of MA-LRTI due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants
Time Frame
Delivery to 360 days after delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Healthy women ≤49 years of age who are between 24 and 36 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria - Maternal Participants: Healthy women ≤49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Receiving prenatal standard of care based on country requirements. Had a fetal anomaly ultrasound examination performed at ≥18 weeks of pregnancy with no significant fetal abnormalities observed. Determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study. Documented negative HIV antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization (Visit 1). Intention to deliver at a hospital or birthing facility where study procedures can be obtained. Expected to be available for the duration of the study and can be contacted by telephone during study participation. Participant is willing to give informed consent for her infant to participate in the study. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol OR If the maternal participant is illiterate, a thumbprinted informed consent must be obtained, which must be signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant has been informed of all pertinent aspects of the study. Inclusion Criteria -Infant Participants: Evidence of a signed and dated ICD signed by the parent(s)/legal guardian(s) OR If the infant participant's maternal participant/parent(s)/legal guardian(s) is illiterate, a thumbprinted informed consent must have been obtained, which must have been signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant/parent(s)/legal guardian(s) has been informed of all pertinent aspects of the study for herself (maternal participant) and her fetus/infant prior to taking part in the study. Parent(s)/legal guardian(s) willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria - Maternal Participants: Prepregnancy body mass index (BMI) of >40 kg/m2. If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any related vaccine. Current pregnancy resulting from in vitro fertilization. Current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and completion of the study, including but not limited to the following: Preeclampsia, eclampsia, or uncontrolled gestational hypertension. Placental abnormality. Polyhydramnios or oligohydramnios. Significant bleeding or blood clotting disorder. Endocrine disorders, including untreated hyperthyroidism or untreated hypothyroidism. This also includes disorders of glucose intolerance (eg, diabetes mellitus type 1 or 2) antedating pregnancy or occurring during pregnancy if uncontrolled at the time of consent. Any signs of premature labor with the current pregnancy or having ongoing intervention (medical/surgical) in the current pregnancy to prevent preterm birth. Prior pregnancy complications or abnormalities at the time of consent, based on the investigator's judgment, that will increase the risk associated with the participation in and completion of the study, including but not limited to the following: Prior preterm delivery ≤34 weeks' gestation. Prior stillbirth or neonatal death. Previous infant with a known genetic disorder or significant congenital anomaly. Major illness of the maternal participant or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the maternal or infant participant's participation in, and completion of, the study or could preclude the evaluation of the maternal participant's response (includes positive serologic testing for regional endemic conditions assessed during routine maternal care, as per local standards of care and obstetric recommendations). Congenital or acquired immunodeficiency disorder, or rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrollment. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. Participation in other studies involving investigational drug(s) within 28 days prior to consent and/or during study participation. Receipt of monoclonal antibodies within the year prior to enrollment or the use of systemic corticosteroids for >14 days within 28 days prior to study enrollment. Permitted treatments include the receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) monoclonal antibodies, prednisone doses of <20 mg/day for ≤14 days and, inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids. Current alcohol abuse or illicit drug use. Note: Marijuana use is not considered an exclusion criterion for the study when elicited in participant screening, though it may be considered illicit in some locales. Receipt of blood or plasma products or immunoglobulin (Ig), from 60 days before investigational product administration, or planned receipt through delivery, with 1 exception, Rho(D) immune globulin (eg, RhoGAM), which can be given at any time. Previous vaccination with any licensed or investigational RSV vaccine or planned. Note: Licensed COVID-19 vaccines or COVID-19 vaccines authorized for temporary or emergency use will not be prohibited during the course of this study. 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 Pfizer employees, including their family members, directly involved in the conduct of the study. Participants who are breastfeeding at the time of enrollment. Exclusion Criteria -Infant Participants: o Infant who is a direct descendant (eg, child or grandchild) of the study personnel.
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
Central Research Associates, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Endocrinology and Internal Medicine Associates, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
OB/GYN Associates of Alabama, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Sharp and Stone OB/GYN PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
St Vincent's Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
UAB Women & Infants Center - UAB Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham/Center for Women's Reproductive Health
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Cullman Clinical Research, Inc
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Cullman Primary Care, PC
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Cullman Regional
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
University of South Alabama Children's and Women's Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
USA Health Strada Patient Care Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Springhill Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Velocity Clinical Research, Gulfport
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Arrowhead Community Hospital
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Banner Thunderbird Hospital
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Abrazo West Campus Hospital
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Facility Name
Velocity Clinical Research - Pheonix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Valleywise Comprehensive Health Center Women's Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
Valleywise Health Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
MedPharmics, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Velocity Clinical Research - Pheonix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Mesquite Pediatrics
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Watching Over Mothers and Babies
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Banner University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Banner University Medical Center ( North Campus )
City
Tucson
State/Province
Arizona
ZIP/Postal Code
87519
Country
United States
Facility Name
St. Bernards Medical Center
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
St. Bernards OBGYN Associates
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
The Children's Clinic of Jonesboro, P.A.
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
The Children's Clinic of Jonesboro, PA
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Century Research Institute
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Chowchilla Medical Center
City
Chowchilla
State/Province
California
ZIP/Postal Code
93610
Country
United States
Facility Name
Loma Linda University Pediatric Clinic - Highland
City
Highland
State/Province
California
ZIP/Postal Code
92346
Country
United States
Facility Name
Century Research Institute
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Matrix Clinical Research
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Chemidox Clinical Trials
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Leonard S. Kurian, M.D., A Medical Corporation
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Women & Infants Pavilion, Antelope Valley Hospital
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Loma Linda University Adventist Health Sciences Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Loma Linda University Faculty Medical Clinics
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Loma Linda University Pediatric Clinics
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Loma Linda Unversity Children's Hospital
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Long Beach Clinical Trials
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
St Mary Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Century Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90006
Country
United States
Facility Name
Matrix Clinical Research..
City
Los Angeles
State/Province
California
ZIP/Postal Code
90006
Country
United States
Facility Name
East LA Doctors Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90023
Country
United States
Facility Name
Hollywood Presbyterian Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
White Memorial Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Century Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Peter Morton Medical Building
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center Drug Information Center Dept
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Ronald Reagan University of California Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA David Geffen School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Affiliated Physician Practice
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Charles E. Ugwu-Oju, M.D., F.A.C.O.G., Obstetrics & Gynecology
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Madera Community Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Madera Family Medical Group
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Monterey Park Hospital
City
Monterey Park
State/Province
California
ZIP/Postal Code
91754
Country
United States
Facility Name
Lucile Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Fomat- Raymond Poliakin, MD.
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Carey Chronis, MD
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Anschutz Inpatient Pavilion 2
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado AO1
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital Inpatient Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital Outpatient Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Leprino Building
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Research II Building
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Delta Memorial Hospital
City
Delta
State/Province
Colorado
ZIP/Postal Code
81416
Country
United States
Facility Name
Colorado Canyon's Hospital
City
Fruita
State/Province
Colorado
ZIP/Postal Code
81521
Country
United States
Facility Name
Boeson Research
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Dino-Peds
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Women's Health Care of Western Colorado
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Boeson Research
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81505
Country
United States
Facility Name
Community Hospital
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81505
Country
United States
Facility Name
SCL St. Mary's Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81505
Country
United States
Facility Name
Montrose Memorial Hospital
City
Montrose
State/Province
Colorado
ZIP/Postal Code
81401
Country
United States
Facility Name
Yale School Medicine Church Street Research Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Emerson Clinical Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Facility Name
Axcess Medical Research
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
North Shore Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33150
Country
United States
Facility Name
Citadelle Clinical Research
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
A1 Imaging of Aventura
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Rainbow Pediatrics
City
Panama City Beach
State/Province
Florida
ZIP/Postal Code
32407
Country
United States
Facility Name
Baldwin Pediatrics
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Emerald Coast Obstetrics and Gynecology
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Emerald Coast Pediatrics
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Gulf Coast Regional Medical Center
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Rainbow Pediatrics
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
American Research Centers of Florida
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory Children's Center Illness POD
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University Investigational Drug Service
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Piedmont Columbus Regional Midtown
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31901
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
1st Choice Urgent Care & Family Medicine
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Bingham Memorial Hospital
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Elite Clinical Trials LLLP
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Grove Creek Medical Center
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
ASR, LLC
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
St. Luke's Boise Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
West Valley Medical Center
City
Caldwell
State/Province
Idaho
ZIP/Postal Code
83605
Country
United States
Facility Name
Clinical Research Prime
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Eastern Idaho Regional Medical Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Mountain View Hospital
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
The Pediatric Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Saltzer Health
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
St. Luke's Meridian Medical Center
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Saltzer Health
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
ASR, LLC
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
Saltzer Health
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
St. Alphonsus Medical Center- Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
St. Luke's Nampa Medical Center
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
Pocatello Women's Health Clinic
City
Pocatello
State/Province
Idaho
ZIP/Postal Code
83201
Country
United States
Facility Name
Portneuf Medical Center
City
Pocatello
State/Province
Idaho
ZIP/Postal Code
83201
Country
United States
Facility Name
1st Choice Urgent Care
City
Pocatello
State/Province
Idaho
ZIP/Postal Code
83204
Country
United States
Facility Name
Clinical Research Prime Rexburg
City
Rexburg
State/Province
Idaho
ZIP/Postal Code
83440
Country
United States
Facility Name
Elite Clinical Trials LLLP
City
Rexburg
State/Province
Idaho
ZIP/Postal Code
83440
Country
United States
Facility Name
Madison Memorial Hospital
City
Rexburg
State/Province
Idaho
ZIP/Postal Code
83440
Country
United States
Facility Name
The Pediatric Center
City
Rigby
State/Province
Idaho
ZIP/Postal Code
83442
Country
United States
Facility Name
Dupont Pediatrics
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Women's Health Advantage
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Mcfarland Clinic PC
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010-3014
Country
United States
Facility Name
Mary Greeley Medical Center
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
McFarland Clinic, P.C.
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
PMG Research of McFarland Clinic
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
The Iowa Clinic
City
Ankeny
State/Province
Iowa
ZIP/Postal Code
50023
Country
United States
Facility Name
Methodist West Hospital
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
The Iowa Clinic, P.C.
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Owensboro Health Regional Hospital
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Research Integrity, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
The Women's Pavillion, P.S.C
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Alexandria Cardiology Clinic - Secondary Research Site
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Cambridge Medical Trials - Main Research Site
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Cambridge Medical Trials
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Rabie Clinic for Women
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Rapides Regional Medical Center Labor and Delivery
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Lakeview Regional Medical Center
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Medpharmics, LLC
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
St. Tammany Parish Hospital
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Velocity Clinical Research
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Ochsner Health Center - West Bank
City
Gretna
State/Province
Louisiana
ZIP/Postal Code
70056
Country
United States
Facility Name
North Oaks Medical Center
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70131
Country
United States
Facility Name
North Oaks Obstetrics & Gynecology
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Facility Name
North Oaks Rural Health Clinic
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Facility Name
MedPharmics LLC
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70508
Country
United States
Facility Name
Crescent City Physicians and Obstetrics
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70005
Country
United States
Facility Name
MedPharmics LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Ochsner Baptist Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Touro Infirmary
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Ochsner Health Center for Children
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Women Under Study, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70125
Country
United States
Facility Name
MedPharmics, LLC
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Slidell Memorial Hospital
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Investigational Pharmacy Service
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
C.S. Mott Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Hutzel-Harper Women's Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University Health Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Wayne State University Physician Group
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Gulfport Memorial Hospital
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39501
Country
United States
Facility Name
MedPharmics, LLC
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Facility Name
MedPharmics
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Facility Name
Singing River Health System
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Baer Pediatrics
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
KDB Enterprises
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Sundance Clinical Research, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Boeson Research (BUT)
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
St James Healthcare
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Benefis Health System
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Boeson Research (GTF)
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Origin Health GTF
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Boeson Research (GTF)
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Marcus Daly Memorial Hospital
City
Hamilton
State/Province
Montana
ZIP/Postal Code
59840
Country
United States
Facility Name
Boeson Research (HLN)
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
St Peters Health
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Boeson Reseach (KAL)
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
The Birth Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59803
Country
United States
Facility Name
Boeson Research LLC
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Boeson Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Community Medical Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Community Physicians Group-Maternal Fetal Medicine
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
St Luke Community Clinic - Ronan
City
Ronan
State/Province
Montana
ZIP/Postal Code
59864
Country
United States
Facility Name
North Valley Hospital
City
Whitefish
State/Province
Montana
ZIP/Postal Code
59937
Country
United States
Facility Name
Grand Island Regional Medical Center
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68801
Country
United States
Facility Name
CHI Health St. Francis
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Grand Island Regional Medical Center
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Mary Lanning
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Facility Name
Meridian Clinical Research
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Facility Name
Midwest Children's Health Research Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68504
Country
United States
Facility Name
Midwest Children's Health Research Institute.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68505
Country
United States
Facility Name
Bryan Health
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Midwest Childrens Health Research Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Women's Health Care Center of Williamsburg
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Midwest Children's Health Research Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68522
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Jaffe Family Womens Care Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Pediatrics at Sheridan Pavilion- Three Cooper Plaza
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Cooper Faculty OBGYN at Cherry Hill
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
Saint Peters University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Cooper Faculty OBGYN at Sewell
City
Sewell
State/Province
New Jersey
ZIP/Postal Code
08080
Country
United States
Facility Name
MedPharmics
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Presbyterian Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
University of New Mexico Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Velocity Clinical Research, Albuquerque
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87107
Country
United States
Facility Name
Lovelace Women's Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
New York Presbyterian of Queens Hospital
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Theresa Lang Children's Ambulatory Center
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Fresh Meadows Family Health Center
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11365
Country
United States
Facility Name
Hollis Women's Center
City
Hollis
State/Province
New York
ZIP/Postal Code
11423
Country
United States
Facility Name
Jackson Heights Family Health Center
City
Jackson Heights
State/Province
New York
ZIP/Postal Code
11372
Country
United States
Facility Name
NYU Langone Hospital - Long Island
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Women's Contemporary Care
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Columbia Doctors
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Audubon Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Center for Prenatal Pediatrics
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Herbert Irving Pavilion
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Morgan Stanley Childrens Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Meridian Clinical Research LLC
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
UNC OB/GYN at Panther Creek (recruitment, randomization, administration of IP)
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27519
Country
United States
Facility Name
UNC Children's Hospital (Pediatric follow up)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
UNC Healthcare (recruitment, randomization, administration of IP)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
UNC OB/GYN at Weaver Crossing (recruitment, randomization, administration of IP)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke Children's Primary Care - Roxboro Street
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Duke Regional Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Duke University.
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Womack Army Medical Center
City
Fort Bragg
State/Province
North Carolina
ZIP/Postal Code
28310
Country
United States
Facility Name
FirstHealth Clinical Trials
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
FirstHealth Moore Regional Hospital
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Sandhills Pediatrics
City
Seven Lakes
State/Province
North Carolina
ZIP/Postal Code
27376
Country
United States
Facility Name
Sandhills Pediatrics
City
Southern Pines
State/Province
North Carolina
ZIP/Postal Code
28387
Country
United States
Facility Name
FirstHealth Southern Pines Women's Health Center
City
Southern Pines
State/Province
North Carolina
ZIP/Postal Code
28388
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati Medical Center Department of Obstetrics and Gynecology
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Dayton Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
HWC Women's Research Center, LLC
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
UC Health West Chester Hospital
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
Integris Yukon Hospital
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Facility Name
Tekton Research
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Facility Name
Allegheny Health and Wellness Pavilion
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
OBGYN Associates of Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507
Country
United States
Facility Name
Liberty Family Practice
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16508
Country
United States
Facility Name
Saint Vincent Hospital
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16544
Country
United States
Facility Name
Reading Hospital - Children's Health Center
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Reading Hospital - Women's Health Center
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Reading Hospital-Family Health Care Center
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Reading Hospital
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Bon Secours St. Francis Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Charleston 0B/GYN
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Coastal Pediatric Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Prisma Health-Upstate Office of Maternal Fetal Medicine
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Lowcountry Womens Specialists
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Summerville Medical Center
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Coastal Pediatric Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Facility Name
Sanford Children's Specialty Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford Obstetrics and Gynecology Clinic (Recruitment, Consenting, IP Administration, and Follow Up)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford Obstetrics and Gynecology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford USD Medical Center (Main Hospital)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford Women's Health Plaza (Recruitment, Consenting, and Follow Up)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Premier Medical Group
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37040
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Texas Health Arlington Memorial Hospital
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Ventavia Research Group, LLC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Medical City Arlington (Women's Hospital)
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Facility Name
St. David's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Tekton Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Center for Women''s Health and Birthcare
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Christus St. Elizabeth Hospital
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Gadolin Research, LLC
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Texas Health Harris Methodist Hospital Hurst-Euless-Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Child Care Pediatrics, P.A.
City
Burleson
State/Province
Texas
ZIP/Postal Code
76028
Country
United States
Facility Name
Ventavia Research Group LLC
City
Burleson
State/Province
Texas
ZIP/Postal Code
76028
Country
United States
Facility Name
Texas Health Presbyterian Hospital Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Ventavia Research Group LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Wise Health System Dectaur
City
Decatur
State/Province
Texas
ZIP/Postal Code
76243
Country
United States
Facility Name
Cline Pediatrics
City
Dickinson
State/Province
Texas
ZIP/Postal Code
77539
Country
United States
Facility Name
Doctor's Hospital Womens Hospital
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
South Texas Health System- Edinburg
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
8th Avenue Obstetrics & Gynecology
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor Scott & White All Saints Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Health Harris Methodist Hospital Fort Worth
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
Texas Health Harris Methodist Hospital Southwest
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Chisholm Trail Pediatrics
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78626
Country
United States
Facility Name
FMC Science
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78626
Country
United States
Facility Name
Georgetown OBGYN
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78626
Country
United States
Facility Name
St. David's Georgetown Hospital
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78626
Country
United States
Facility Name
Baylor Scott & White of Grapevine (Hospital)
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
Ventavia Research Group, LLC
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
Hany H. Ahmed, MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
HG Pediatrics
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Van Tran Family Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Ventavia Research Group, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Memorial Hermann Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
UT Health Women's Research Center at Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
HCA: The Women's Hospital of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Javara Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Privia Medical Group Gulf Coast, PLLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
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
AdventHealth Family Medicine Rural Health Clinic, Inc.
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
FMC Science
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
Maximos Ob/Gyn
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
DCOL Center for Clinical Research
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Diagnostic Clinic of Longview (Hollybrook)
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Diagnostic Clinic of Longview (Medical Circle)
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Longview Regional Medical Center
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Rio Grande Regional Hospital
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
South Texas Health System- McAllen
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Dr. Ruben Aleman and Associates
City
McAllen
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Facility Name
Medical City Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Texas Health Presbyterian Hospital Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Ventavia Research Group LLC
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
St. Luke's Baptist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Tekton Research, Inc.
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
Medical City Weatherford
City
Weatherford
State/Province
Texas
ZIP/Postal Code
76086
Country
United States
Facility Name
Ventavia Research Group
City
Weatherford
State/Province
Texas
ZIP/Postal Code
76086
Country
United States
Facility Name
Alpine Medical Group
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Intermountain Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
JBR Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Old Farm Obstetrics & Gynecology, LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Holladay Family Practice
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
St. Marks Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Sentara Leigh Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
The Group for Women
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Tidewater Physicians for Women
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Clinical Research Partners, LLC
City
North Chesterfield
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Virginia Commonwealth Univeristy Health Systems-Children's Pavilion
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Virginia Commonwealth University Health System-Main Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Virginia Commonwealth University Health System-Nelson Clinic
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Clinical Research Partners, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
VCU Health Adult Outpatient Pavillion
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Tidewater Physicians for Women
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
UW Neighborhood Ravenna Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
UW Neighborhood South Lake Union Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Washington Medical Center - Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
UW Midwives Clinic at Northwest Outpatient Medical center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
University of Washington Medical Center- Montlake
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
UW Neighborhood Shoreline Clinic
City
Shoreline
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
MultiCare Health System - Mary Bridge Children's Health Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Multicare Health System-Multicare Women's Center Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Multicare Health System-Pediatrics Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Multicare Health System-Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
MultiCare Institute for Research & Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Cabell Huntington Hospital
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Marshall Health
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
University Physicians and Surgeons dba Marshall Health Department of Obstetrics and Gynecology
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
University Physicians and Surgeons dba Marshall Health Department of Pediatrics
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Marshfield Medical Center - Marshfield
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Marshfield Medical Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Clínica del Niño y la Madre
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Hospital Italiano de Rosario
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Instituto de Maternidad y Ginecologia: "Nuestra Senora de las Mercedes"
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Sanatorio Mater Dei
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Centro de Investigación Clinica OSECAC
City
Buenos Aires
ZIP/Postal Code
C1040 AAL
Country
Argentina
Facility Name
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
City
Caba
ZIP/Postal Code
C1426BOS
Country
Argentina
Facility Name
Hospital Publico Materno Infantil
City
Salta
ZIP/Postal Code
4400
Country
Argentina
Facility Name
Women's and Children's Hospital
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Monash Children's Hospital
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Barwon Health, University Hospital Geelong
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Perth Children's Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Telethon Kids Institute
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
St John of God Hospital Subiaco
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Hospital Universitario/GAMP - Grupo de Apoio a Medicina Preventiva e a Saude Publica
City
Canoas
State/Province
RS
ZIP/Postal Code
92425-900
Country
Brazil
Facility Name
Hospital Moinhos de Vento - HMV
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-001
Country
Brazil
Facility Name
Hospital Moinhos de Vento - HMV
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90560-030
Country
Brazil
Facility Name
Maternidade Darcy Vargas
City
Joinville
State/Province
SC
ZIP/Postal Code
89202-190
Country
Brazil
Facility Name
Clinica de Alergia Martti Antila S/S Ltda./ CMPC - Consultoria Medica e Pesquisa Clinica
City
Sorocaba
State/Province
SP
ZIP/Postal Code
18040-425
Country
Brazil
Facility Name
Canadian Center for Vaccinology - IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
CHU Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
CHU de Québec-Université Laval
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Hospital Base San José de Osorno (Servicio de Obstetricia y Ginecología)
City
Osorno
State/Province
Región DE LOS Lagos
ZIP/Postal Code
5311523
Country
Chile
Facility Name
Centro de Capacitación e Investigaciones Clínicas (CCIC)
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
7510186
Country
Chile
Facility Name
Clinica Universidad de los Andes
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
7620157
Country
Chile
Facility Name
Satellite (Deliveries): Hospital San Juan de Dios (Maternidad)
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8350488
Country
Chile
Facility Name
Instituto de Investigaciones Materno Infantil (IDIMI)
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8360160
Country
Chile
Facility Name
Deliveries (satellite): Hospital San Jose
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8380419
Country
Chile
Facility Name
Grupo Estudios Clínicos Infectología Respiratoria
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8380453
Country
Chile
Facility Name
Deliveries (satellite): Hospital Clínico Universidad de Chile
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Centro Internacional de Estudios Clinicos - CIEC
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Hospital Padre Hurtado
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8880465
Country
Chile
Facility Name
Aarhus Universitetshospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Nordsjællands Hospital
City
Hillerod
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Odense Universitets Hospital
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
FVR, Tampere Clinic
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33100
Country
Finland
Facility Name
FVR, Oulu Clinic
City
Oulu
State/Province
Pohjois-pohjanmaa
ZIP/Postal Code
90220
Country
Finland
Facility Name
MeVac
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
FVR, Kokkola Clinic
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
Kokkola Vaccine Research Clinic
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
FVR, Oulun rokotetutkimusklinikka
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Oulu Vaccine Research Clinic
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Tampereen yliopisto Oulun Rokotetutkimusklinikka
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
FVR, Pori Clinic
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
Pori Vaccine Research Clinic
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
Seinajoki Vaccine Research Clinic
City
Seinajoki
ZIP/Postal Code
60100
Country
Finland
Facility Name
Tampere Vaccine Research Clinic
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
FVR, Turku Clinic
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Tampere University Vaccine Research Turku
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Turku Vaccine Research Clinic
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Medical Research Council Unit the Gambia at the London School of Hygiene & Tropical Medicine (LSHTM)
City
Sukuta
Country
Gambia
Facility Name
Fukui Aiiku Hospital
City
Fukui-shi
State/Province
Fukui
ZIP/Postal Code
910-0833
Country
Japan
Facility Name
Hyogo Prefectural Amagasaki General Medical Center
City
Amagasaki
State/Province
Hyōgo
ZIP/Postal Code
660-8550
Country
Japan
Facility Name
Shonan Fujisawa Tokushukai Hospital
City
Fujisawa
State/Province
Kanagawa
ZIP/Postal Code
251-0041
Country
Japan
Facility Name
Rakuwakai Otowa Hospital
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
607-8062
Country
Japan
Facility Name
Kuwana City Medical Center
City
Kuwana-shi
State/Province
MIE
ZIP/Postal Code
511-0061
Country
Japan
Facility Name
Sendai City Hospital
City
Sendai-city
State/Province
Miyagi
ZIP/Postal Code
982-8502
Country
Japan
Facility Name
National Hospital Organization Beppu Medical Center
City
Beppu
State/Province
Oita
ZIP/Postal Code
874-0011
Country
Japan
Facility Name
Social Medical Corporation KARIYUSHIKAI Heartlife Hospital
City
Nakagami-gun
State/Province
Okinawa
ZIP/Postal Code
901-2492
Country
Japan
Facility Name
Osaka Habikino Medical Center
City
Habikino
State/Province
Osaka
ZIP/Postal Code
583-8588
Country
Japan
Facility Name
National Hospital Organization Tokyo Medical Center
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Saitama City hospital
City
Saitama
ZIP/Postal Code
336-8522
Country
Japan
Facility Name
Shizuoka General Hospital
City
Shizuoka
ZIP/Postal Code
420-8527
Country
Japan
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kyunghee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Arke SMO S.A. de C.V.
City
Cuauhtemoc
State/Province
Ciudad DE Mexico
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Asociacion Mexicana para la Investigacion Clinica, A. C.
City
Pachuca de Soto
State/Province
Hidalgo
ZIP/Postal Code
42070
Country
Mexico
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Hospital General de Durango
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Arke SMO S.A. de C.V.
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Facility Name
Spaarne Gasthuis (Kennemer Gasthuis)
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Diakonessenhuis Utrecht
City
Utrecht
ZIP/Postal Code
3582 KE
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Botany Downs Primary Birthing Unit
City
Golflands
State/Province
Auckland
ZIP/Postal Code
2013
Country
New Zealand
Facility Name
Papakura Primary Birthing Unit
City
Papakura North
State/Province
Auckland
ZIP/Postal Code
2110
Country
New Zealand
Facility Name
Middlemore Hospital
City
Papatoetoe
State/Province
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Pukekohe Primary Birthing Unit
City
Pukekohe
State/Province
Auckland
ZIP/Postal Code
2120
Country
New Zealand
Facility Name
New Zealand Clinical Research (Christchurch)
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Optimal Clinical Trials Ltd
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Aotearoa Clinical Trials Trust (ACTT)
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Middlemore Clinical Trials(Middlemore Hospital)
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Christchurch Hospital (Canterbury District Health Board)
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Capital, Coast and Hutt Valley District- Wellington Regional Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Wellington Hospital (Capital and Coast District Health Board)
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Asian Hospital and Medical Center
City
Muntinlupa City
State/Province
Metro Manila
ZIP/Postal Code
1780
Country
Philippines
Facility Name
JOSHA Research
City
Bloemfontein
State/Province
FREE State
ZIP/Postal Code
9300
Country
South Africa
Facility Name
Wits RHI Shandukani Research Centre
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2001
Country
South Africa
Facility Name
Into Research, West Wing Medical Centre
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Setshaba Research Centre
City
Soshanguve
State/Province
Gauteng
ZIP/Postal Code
0152
Country
South Africa
Facility Name
University of the Witwatersrand Vaccines & Infectious Diseases Analytics (VIDA)
City
Soweto
State/Province
Gauteng
ZIP/Postal Code
1862
Country
South Africa
Facility Name
Limpopo Clinical Research Initiative
City
Thabazimbi
State/Province
Limpopo
ZIP/Postal Code
0380
Country
South Africa
Facility Name
MRC Unit on Child and Adolescent Health
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Khayelitsha Satellite Site: Michael Mapongwana Community Health Centre
City
Khayelitsha
State/Province
Western CAPE
ZIP/Postal Code
7784
Country
South Africa
Facility Name
FAMCRU, University of Stellenbosch, Paediatric
City
Parow Valley
State/Province
Western CAPE
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Kraaifontein Satellite site
City
Cape Town
ZIP/Postal Code
7570
Country
South Africa
Facility Name
University of the Witwatersrand Vaccines & Infectious Diseases Analytics (VIDA)
City
Soweto
ZIP/Postal Code
1862
Country
South Africa
Facility Name
Worcester Satellite site
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
Facility Name
CHUS - Hospital Clinico Universitario
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital de Antequera
City
Antequera
State/Province
Malaga
ZIP/Postal Code
29200
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Madrid Puerta del Sur Mostoles
City
Mostoles
ZIP/Postal Code
28938
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hsinchu Mackay Memorial Hospital
City
Hsinchu City
ZIP/Postal Code
30046
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei City
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

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
Citations:
PubMed Identifier
34774184
Citation
Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11. No abstract available.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3671008
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

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