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

January 17, 2025 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14727

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1425
        • Sanatorio Mater Dei
      • Buenos Aires, Argentina, C1040 AAL
        • Centro de Investigación Clinica OSECAC
      • Caba, Argentina, C1426BOS
        • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
      • Salta, Argentina, 4400
        • Hospital Público Materno Infantil
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Clinica Del Niño Y La Madre
    • Santa FE
      • Rosario, Santa FE, Argentina, 2000
        • Hospital Italiano de Rosario
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • Instituto de Maternidad y Ginecologia: "Nuestra Senora de las Mercedes"
  • Australia
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • Women's and Children's Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Children's Hospital
      • Geelong, Victoria, Australia, 3220
        • Barwon Health, University Hospital Geelong
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Telethon Kids Institute
      • Subiaco, Western Australia, Australia, 6008
        • St John of God Hospital Subiaco
  • Brazil
    • RS
      • Canoas, RS, Brazil, 92425-900
        • Hospital Universitario/GAMP - Grupo de Apoio a Medicina Preventiva e a Saude Publica
      • Porto Alegre, RS, Brazil, 90035-001
        • Hospital Moinhos de Vento - HMV
      • Porto Alegre, RS, Brazil, 90560-030
        • Hospital Moinhos de Vento - HMV
    • SC
      • Joinville, SC, Brazil, 89202-190
        • Maternidade Darcy Vargas
    • SP
      • Sorocaba, SP, Brazil, 18040-425
        • Clinica de Alergia Martti Antila S/S Ltda./ CMPC - Consultoria Medica e Pesquisa Clinica
  • Canada
      • Quebec, Canada, G1V 4G2
        • CHU de Quebec-Universite Laval
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • Canadian Center for Vaccinology - IWK Health Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • CHU Sainte-Justine
  • Chile
    • Región DE LOS Lagos
      • Osorno, Región DE LOS Lagos, Chile, 5311523
        • Hospital Base San José de Osorno (Servicio de Obstetricia y Ginecología)
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 7510186
        • Centro de Capacitación e Investigaciones Clínicas (CCIC)
      • Santiago, Región Metropolitana, Chile, 7620157
        • Clínica Universidad de los Andes
      • Santiago, Región Metropolitana, Chile, 8350488
        • Satellite (Deliveries): Hospital San Juan de Dios (Maternidad)
      • Santiago, Región Metropolitana, Chile, 8360160
        • Instituto de Investigaciones Materno Infantil (IDIMI)
      • Santiago, Región Metropolitana, Chile, 8380419
        • Deliveries (satellite): Hospital San Jose
      • Santiago, Región Metropolitana, Chile, 8380453
        • Grupo Estudios Clínicos Infectología Respiratoria
      • Santiago, Región Metropolitana, Chile, 8380456
        • Deliveries (satellite): Hospital Clínico Universidad de Chile
      • Santiago, Región Metropolitana, Chile, 8420383
        • Centro Internacional de Estudios Clinicos - CIEC
      • Santiago, Región Metropolitana, Chile, 8880465
        • Hospital Padre Hurtado
  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital
      • Hillerod, Denmark, 3400
        • Nordsjællands Hospital
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital
      • Odense, Denmark, DK-5000
        • Odense Universitets Hospital
  • Finland
      • Helsinki, Finland, 00290
        • MeVac
      • Kokkola, Finland, 67100
        • Kokkola Vaccine Research Clinic
      • Oulu, Finland, 90220
        • Oulu Vaccine Research Clinic
      • Oulu, Finland, 90220
        • Tampereen yliopisto Oulun Rokotetutkimusklinikka
      • Pori, Finland, 28100
        • Pori Vaccine Research Clinic
      • Seinajoki, Finland, 60100
        • Seinäjoki Vaccine Research Clinic
      • Tampere, Finland, 33100
        • Tampere Vaccine Research Clinic
      • Turku, Finland, 20520
        • Turku Vaccine Research Clinic
  • Gambia
      • Fajara KMC, Gambia
        • Medical Research Council Unit the Gambia at the London School of Hygiene & Tropical Medicine
      • Sukuta, Gambia
        • Medical Research Council Unit the Gambia at the London School of Hygiene & Tropical Medicine (LSHTM)
  • Japan
      • Saitama, Japan, 336-8522
        • Saitama City Hospital
      • Shizuoka, Japan, 420-8527
        • Shizuoka General Hospital
    • Fukui
      • Fukui-shi, Fukui, Japan, 910-0833
        • Fukui Aiiku Hospital
    • Hyōgo
      • Amagasaki, Hyōgo, Japan, 660-8550
        • Hyogo Prefectural Amagasaki General Medical Center
    • Kanagawa
      • Fujisawa, Kanagawa, Japan, 251-0041
        • Shonan Fujisawa Tokushukai Hospital
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 607-8062
        • Rakuwakai Otowa Hospital
    • MIE
      • Kuwana-shi, MIE, Japan, 511-0061
        • Kuwana City Medical Center
    • Miyagi
      • Sendai-city, Miyagi, Japan, 982-8502
        • Sendai City Hospital
    • Oita
      • Beppu, Oita, Japan, 874-0011
        • National Hospital Organization Beppu Medical Center
    • Okinawa
      • Nakagami-gun, Okinawa, Japan, 901-2492
        • Social Medical Corporation KARIYUSHIKAI Heartlife Hospital
    • Osaka
      • Habikino, Osaka, Japan, 583-8588
        • Osaka Habikino Medical Center
    • Tokyo
      • Meguro-ku, Tokyo, Japan, 152-8902
        • National Hospital Organization Tokyo Medical Center
  • Korea, Republic of
      • Gwangju, Korea, Republic of, 61469
        • Chonnam National University Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 05278
        • Kyunghee University Hospital at Gangdong
  • Mexico
      • Durango, Mexico, 34000
        • Hospital General de Durango
      • Veracruz, Mexico, 91910
        • Arke SMO S.A. de C.V.
    • Ciudad DE Mexico
      • Cuauhtemoc, Ciudad DE Mexico, Mexico, 06700
        • Arke SMO S.A. de C.V.
    • Hidalgo
      • Pachuca de Soto, Hidalgo, Mexico, 42070
        • Asociacion Mexicana para la Investigacion Clinica, A. C.
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64460
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Netherlands
      • Hoofddorp, Netherlands, 2134 TM
        • Spaarne Gasthuis (Kennemer Gasthuis)
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
      • Utrecht, Netherlands, 3582 KE
        • Diakonessenhuis Utrecht
  • New Zealand
      • Auckland, New Zealand, 1010
        • Optimal Clinical Trials Ltd
      • Auckland, New Zealand, 2025
        • Aotearoa Clinical Trials Trust (ACTT)
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital (Canterbury District Health Board)
      • Wellington, New Zealand, 6021
        • Capital, Coast and Hutt Valley District- Wellington Regional Hospital
    • Auckland
      • Golflands, Auckland, New Zealand, 2013
        • Botany Downs Primary Birthing Unit
      • Papakura North, Auckland, New Zealand, 2110
        • Papakura Primary Birthing Unit
      • Papatoetoe, Auckland, New Zealand, 2025
        • Middlemore Hospital
      • Pukekohe, Auckland, New Zealand, 2120
        • Pukekohe Primary Birthing Unit
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • New Zealand Clinical Research (ChristChurch)
  • Philippines
    • Metro Manila
      • Muntinlupa City, Metro Manila, Philippines, 1780
        • Asian Hospital and Medical Center
  • South Africa
      • Cape Town, South Africa, 7570
        • Kraaifontein Satellite site
      • Worcester, South Africa, 6850
        • Worcester Satellite site
    • FREE State
      • Bloemfontein, FREE State, South Africa, 9300
        • Josha Research
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2001
        • Wits RHI Shandukani Research Centre
      • Pretoria, Gauteng, South Africa, 0181
        • Into Research, West Wing Medical Centre
      • Soshanguve, Gauteng, South Africa, 0152
        • Setshaba Research Centre
      • Soweto, Gauteng, South Africa, 1862
        • University of the Witwatersrand Vaccines & Infectious Diseases Analytics (VIDA)
    • Limpopo
      • Thabazimbi, Limpopo, South Africa, 0380
        • Limpopo Clinical Research Initiative
    • Western CAPE
      • Cape Town, Western CAPE, South Africa, 7700
        • MRC Unit on Child And Adolescent Health
      • Khayelitsha, Western CAPE, South Africa, 7784
        • Khayelitsha Satellite Site: Michael Mapongwana Community Health Centre
      • Parow Valley, Western CAPE, South Africa, 7505
        • FAMCRU, University of Stellenbosch, Paediatric
  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Mostoles, Spain, 28938
        • Hospital Madrid Puerta del Sur Mostoles
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • CHUS - Hospital Clinico Universitario
    • Malaga
      • Antequera, Malaga, Spain, 29200
        • Hospital de Antequera
  • Taiwan
      • Hsinchu, Taiwan, 30071
        • HsinChu MacKay Memorial Hospital
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei City, Taiwan, 10449
        • Mackay Memorial Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Children's of Alabama
      • Birmingham, Alabama, United States, 35205
        • Central Research Associates, Inc.
      • Birmingham, Alabama, United States, 35205
        • Endocrinology and Internal Medicine Associates, PC
      • Birmingham, Alabama, United States, 35205
        • OB/GYN Associates of Alabama, PC
      • Birmingham, Alabama, United States, 35205
        • Sharp and Stone OB/GYN PC
      • Birmingham, Alabama, United States, 35205
        • St Vincent's Hospital
      • Birmingham, Alabama, United States, 35233
        • UAB Women & Infants Center - UAB Medicine
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham/Center for Women's Reproductive Health
      • Cullman, Alabama, United States, 35058
        • Cullman Clinical Research, Inc
      • Cullman, Alabama, United States, 35058
        • Cullman Primary Care, PC
      • Cullman, Alabama, United States, 35058
        • Cullman Regional
      • Mobile, Alabama, United States, 36604
        • USA Health Strada Patient Care Center
      • Mobile, Alabama, United States, 36604
        • University of South Alabama Children's and Women's Hospital
      • Mobile, Alabama, United States, 36608
        • Springhill Medical Center
      • Mobile, Alabama, United States, 36608
        • Velocity Clinical Research, Gulfport
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Valleywise Comprehensive Health Center Women's Clinic
      • Phoenix, Arizona, United States, 85008
        • Valleywise Health Medical Center
      • Phoenix, Arizona, United States, 85006
        • Velocity Clinical Research - Pheonix
      • Tucson, Arizona, United States, 85724
        • Banner University Medical Center
      • Tucson, Arizona, United States, 85724
        • University of Arizona
      • Tucson, Arizona, United States, 85712
        • Mesquite Pediatrics
      • Tucson, Arizona, United States, 85712
        • Watching Over Mothers and Babies
      • Tucson, Arizona, United States, 87519
        • Banner University Medical Center ( North Campus )
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • The Children's Clinic of Jonesboro, P.A.
      • Jonesboro, Arkansas, United States, 72401
        • St. Bernards Medical Center
      • Jonesboro, Arkansas, United States, 72401
        • St. Bernards OBGYN Associates
      • Jonesboro, Arkansas, United States, 72401
        • The Children's Clinic of Jonesboro, PA
    • California
      • Bellflower, California, United States, 90706
        • Century Research Institute
      • Chowchilla, California, United States, 93610
        • Chowchilla Medical Center
      • Highland, California, United States, 92346
        • Loma Linda University Pediatric Clinic - Highland
      • Huntington Park, California, United States, 90255
        • Century Research Institute
      • Huntington Park, California, United States, 90255
        • Matrix Clinical Research
      • Lancaster, California, United States, 93534
        • Chemidox Clinical Trials
      • Lancaster, California, United States, 93534
        • Leonard S. Kurian, M.D., A Medical Corporation
      • Lancaster, California, United States, 93534
        • Women & Infants Pavilion, Antelope Valley Hospital
      • Loma Linda, California, United States, 92354
        • Loma Linda University Adventist Health Sciences Center
      • Loma Linda, California, United States, 92354
        • Loma Linda University Faculty Medical Clinics
      • Loma Linda, California, United States, 92354
        • Loma Linda University Pediatric Clinics
      • Loma Linda, California, United States, 92354
        • Loma Linda Unversity Children's Hospital
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center
      • Long Beach, California, United States, 90806
        • Long Beach Clinical Trials
      • Long Beach, California, United States, 90806
        • St Mary Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA David Geffen School of Medicine
      • Los Angeles, California, United States, 90027
        • Hollywood Presbyterian Medical Center
      • Los Angeles, California, United States, 90006
        • Century Research Institute
      • Los Angeles, California, United States, 90006
        • Matrix Clinical Research..
      • Los Angeles, California, United States, 90023
        • East LA Doctors Hospital
      • Los Angeles, California, United States, 90033
        • White Memorial Medical Center
      • Los Angeles, California, United States, 90095
        • Peter Morton Medical Building
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center Drug Information Center Dept
      • Los Angeles, California, United States, 90095
        • Ronald Reagan University of California Los Angeles Medical Center
      • Los Angeles, California, United States, 90033
        • Century Research Institute
      • Madera, California, United States, 93637
        • Affiliated Physician Practice
      • Madera, California, United States, 93637
        • Charles E. Ugwu-Oju, M.D., F.A.C.O.G., Obstetrics & Gynecology
      • Madera, California, United States, 93637
        • Madera Community Hospital
      • Madera, California, United States, 93637
        • Madera Family Medical Group
      • Monterey Park, California, United States, 91754
        • Monterey Park Hospital
      • Palo Alto, California, United States, 94304
        • Stanford University
      • Palo Alto, California, United States, 94304
        • Lucile Packard Children's Hospital
      • Thousand Oaks, California, United States, 91360
        • Fomat- Raymond Poliakin, MD.
      • Ventura, California, United States, 93003
        • Carey Chronis, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Inpatient Pavilion 2
      • Aurora, Colorado, United States, 80045
        • University of Colorado AO1
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital Inpatient Pavilion
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital Outpatient Pavilion
      • Aurora, Colorado, United States, 80045
        • University of Colorado Leprino Building
      • Aurora, Colorado, United States, 80045
        • University of Colorado Research II Building
      • Delta, Colorado, United States, 81416
        • Delta Memorial Hospital
      • Fruita, Colorado, United States, 81521
        • Colorado Canyon's Hospital
      • Grand Junction, Colorado, United States, 81501
        • Boeson Research
      • Grand Junction, Colorado, United States, 81501
        • Dino-Peds
      • Grand Junction, Colorado, United States, 81501
        • Women's Health Care of Western Colorado
      • Grand Junction, Colorado, United States, 81505
        • Boeson Research
      • Grand Junction, Colorado, United States, 81505
        • Community Hospital
      • Grand Junction, Colorado, United States, 81505
        • SCL St. Mary's Medical Center
      • Montrose, Colorado, United States, 81401
        • Montrose Memorial Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale School Medicine Church Street Research Unit
    • District of Columbia
      • Washington, District of Columbia, United States, 20011
        • Emerson Clinical Research Institute
    • Florida
      • Loxahatchee Groves, Florida, United States, 33470
        • Axcess Medical Research
      • Miami, Florida, United States, 33150
        • North Shore Medical Center
      • North Miami Beach, Florida, United States, 33162
        • Citadelle Clinical Research
      • North Miami Beach, Florida, United States, 33180
        • A1 Imaging of Aventura
      • Panama City, Florida, United States, 32405
        • Baldwin Pediatrics
      • Panama City, Florida, United States, 32405
        • Emerald Coast Obstetrics and Gynecology
      • Panama City, Florida, United States, 32405
        • Emerald Coast Pediatrics
      • Panama City, Florida, United States, 32405
        • Gulf Coast Regional Medical Center
      • Panama City, Florida, United States, 32405
        • Rainbow Pediatrics
      • Panama City Beach, Florida, United States, 32407
        • Rainbow Pediatrics
      • Pembroke Pines, Florida, United States, 33027
        • American Research Centers of Florida
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30322
        • Emory Clinic
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine
      • Atlanta, Georgia, United States, 30322
        • Emory University Investigational Drug Service
      • Columbus, Georgia, United States, 31904
        • Columbus Regional Research Institute
      • Columbus, Georgia, United States, 31901
        • Piedmont Columbus Regional Midtown
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • 1st Choice Urgent Care & Family Medicine
      • Blackfoot, Idaho, United States, 83221
        • Bingham Memorial Hospital
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials LLLP
      • Blackfoot, Idaho, United States, 83221
        • Grove Creek Medical Center
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Regional Medical Center
      • Boise, Idaho, United States, 83702
        • ASR, LLC
      • Boise, Idaho, United States, 83712
        • St. Luke's Boise Medical Center
      • Caldwell, Idaho, United States, 83605
        • West Valley Medical Center
      • Idaho Falls, Idaho, United States, 83404
        • Clinical Research Prime
      • Idaho Falls, Idaho, United States, 83404
        • Eastern Idaho Regional Medical Center
      • Idaho Falls, Idaho, United States, 83404
        • Mountain View Hospital
      • Idaho Falls, Idaho, United States, 83404
        • The Pediatric Center
      • Meridian, Idaho, United States, 83642
        • Saltzer Health
      • Meridian, Idaho, United States, 83642
        • St. Luke's Meridian Medical Center
      • Nampa, Idaho, United States, 83687
        • ASR, LLC
      • Nampa, Idaho, United States, 83686
        • Saltzer Health
      • Nampa, Idaho, United States, 83687
        • Saltzer Health
      • Nampa, Idaho, United States, 83687
        • St. Alphonsus Medical Center- Nampa
      • Nampa, Idaho, United States, 83687
        • St. Luke's Nampa Medical Center
      • Pocatello, Idaho, United States, 83201
        • Pocatello Women's Health Clinic
      • Pocatello, Idaho, United States, 83201
        • Portneuf Medical Center
      • Pocatello, Idaho, United States, 83204
        • 1st Choice Urgent Care
      • Rexburg, Idaho, United States, 83440
        • Clinical Research Prime Rexburg
      • Rexburg, Idaho, United States, 83440
        • Elite Clinical Trials LLLP
      • Rexburg, Idaho, United States, 83440
        • Madison Memorial Hospital
      • Rigby, Idaho, United States, 83442
        • The Pediatric Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Dupont Pediatrics
      • Fort Wayne, Indiana, United States, 46825
        • Women's Health Advantage
    • Iowa
      • Ames, Iowa, United States, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, United States, 50010
        • McFarland Clinic, P.C.
      • Ames, Iowa, United States, 50010
        • McFarland Clinic PC
      • Ankeny, Iowa, United States, 50023
        • The Iowa Clinic
      • West Des Moines, Iowa, United States, 50266
        • Methodist West Hospital
      • West Des Moines, Iowa, United States, 50266
        • The Iowa Clinic, P.C.
    • Kansas
      • El Dorado, Kansas, United States, 67042
        • Alliance for Multispecialty Research, LLC
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Newton, Kansas, United States, 67114
        • Alliance for Multispecialty Research, LLC
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Research Integrity, LLC
      • Owensboro, Kentucky, United States, 42303
        • Owensboro Health Regional Hospital
      • Owensboro, Kentucky, United States, 42303
        • The Women's Pavillion, P.S.C
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Alexandria Cardiology Clinic - Secondary Research Site
      • Alexandria, Louisiana, United States, 71301
        • Cambridge Medical Trials - Main Research Site
      • Alexandria, Louisiana, United States, 71301
        • Cambridge Medical Trials
      • Alexandria, Louisiana, United States, 71301
        • Rabie Clinic for Women
      • Alexandria, Louisiana, United States, 71301
        • Rapides Regional Medical Center Labor and Delivery
      • Covington, Louisiana, United States, 70433
        • St. Tammany Parish Hospital
      • Covington, Louisiana, United States, 70433
        • Lakeview Regional Medical Center
      • Covington, Louisiana, United States, 70433
        • Velocity Clinical Research
      • Gretna, Louisiana, United States, 70056
        • Ochsner Health Center - West Bank
      • Hammond, Louisiana, United States, 70131
        • North Oaks Medical Center
      • Hammond, Louisiana, United States, 70403
        • North Oaks Obstetrics & Gynecology
      • Hammond, Louisiana, United States, 70403
        • North Oaks Rural Health Clinic
      • Lafayette, Louisiana, United States, 70508
        • MedPharmics LLC
      • Metairie, Louisiana, United States, 70005
        • Crescent City Physicians and Obstetrics
      • Metairie, Louisiana, United States, 70006
        • MedPharmics LLC
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, United States, 70115
        • Ochsner Baptist Medical Center
      • New Orleans, Louisiana, United States, 70115
        • Touro Infirmary
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Health Center for Children
      • New Orleans, Louisiana, United States, 70125
        • Women Under Study, LLC
      • Slidell, Louisiana, United States, 70458
        • Slidell Memorial Hospital
      • Slidell, Louisiana, United States, 70458
        • Velocity Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Boston, Massachusetts, United States, 02118
        • Investigational Pharmacy Service
    • Michigan
      • Detroit, Michigan, United States, 48201
        • C.S. Mott Center
      • Detroit, Michigan, United States, 48201
        • Hutzel-Harper Women's Hospital
      • Detroit, Michigan, United States, 48201
        • University Health Center
      • Southfield, Michigan, United States, 48034
        • Wayne State University Physician Group
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • Velocity Clinical Research
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital
      • Saint Louis, Missouri, United States, 63141
        • Sundance Clinical Research, LLC
      • Saint Louis, Missouri, United States, 63110
        • Barnes Jewish Hospital
      • Saint Louis, Missouri, United States, 63131
        • Baer Pediatrics
      • Saint Louis, Missouri, United States, 63141
        • KDB Enterprises
    • Montana
      • Butte, Montana, United States, 59701
        • Boeson Research (BUT)
      • Butte, Montana, United States, 59701
        • St James Healthcare
      • Great Falls, Montana, United States, 59405
        • Benefis Health System
      • Great Falls, Montana, United States, 59405
        • Origin Health GTF
      • Great Falls, Montana, United States, 59804
        • Boeson Research (GTF)
      • Hamilton, Montana, United States, 59840
        • Marcus Daly Memorial Hospital
      • Helena, Montana, United States, 59601
        • Boeson Research (HLN)
      • Helena, Montana, United States, 59601
        • St Peters Health
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, United States, 59901
        • Boeson Reseach (KAL)
      • Missoula, Montana, United States, 59803
        • The Birth Center
      • Missoula, Montana, United States, 59804
        • Boeson Research LLC
      • Missoula, Montana, United States, 59804
        • Boeson Research
      • Missoula, Montana, United States, 59804
        • Community Medical Center
      • Missoula, Montana, United States, 59804
        • Community Physicians Group-Maternal Fetal Medicine
      • Ronan, Montana, United States, 59864
        • St Luke Community Clinic - Ronan
      • Whitefish, Montana, United States, 59937
        • North Valley Hospital
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Meridian Clinical Research, LLC
      • Grand Island, Nebraska, United States, 68803
        • CHI Health St. Francis
      • Grand Island, Nebraska, United States, 68801
        • Grand Island Regional Medical Center
      • Hastings, Nebraska, United States, 68901
        • Mary Lanning
      • Hastings, Nebraska, United States, 68901
        • Meridian Clinical Research
      • Lincoln, Nebraska, United States, 68504
        • Midwest Children's Health Research Institute
      • Lincoln, Nebraska, United States, 68505
        • Midwest Children's Health Research Institute.
      • Lincoln, Nebraska, United States, 68506
        • Bryan Health
      • Lincoln, Nebraska, United States, 68516
        • Midwest Childrens Health Research Institute
      • Lincoln, Nebraska, United States, 68516
        • Women's Health Care Center of Williamsburg
      • Lincoln, Nebraska, United States, 68522
        • Midwest Children's Health Research Institute
      • Norfolk, Nebraska, United States, 68701
        • Velocity Clinical Research, Norfolk
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
      • Camden, New Jersey, United States, 08103
        • Jaffe Family Womens Care Center
      • Camden, New Jersey, United States, 08103
        • Pediatrics at Sheridan Pavilion- Three Cooper Plaza
      • Cherry Hill, New Jersey, United States, 08034
        • Cooper Faculty OBGYN at Cherry Hill
      • New Brunswick, New Jersey, United States, 08901
        • Saint Peters University Hospital
      • Sewell, New Jersey, United States, 08080
        • Cooper Faculty OBGYN at Sewell
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Presbyterian Hospital
      • Albuquerque, New Mexico, United States, 87102
        • MedPharmics
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Hospital
      • Albuquerque, New Mexico, United States, 87109
        • Lovelace Women's Hospital
      • Albuquerque, New Mexico, United States, 87107
        • Velocity Clinical Research, Albuquerque
    • New York
      • Flushing, New York, United States, 11355
        • New York Presbyterian of Queens Hospital
      • Flushing, New York, United States, 11355
        • Theresa Lang Children's Ambulatory Center
      • Fresh Meadows, New York, United States, 11365
        • Fresh Meadows Family Health Center
      • Hollis, New York, United States, 11423
        • Hollis Women's Center
      • Jackson Heights, New York, United States, 11372
        • Jackson Heights Family Health Center
      • Mineola, New York, United States, 11501
        • NYU Langone Hospital - Long Island
      • Mineola, New York, United States, 11501
        • Women's Contemporary Care
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
      • New York, New York, United States, 10019
        • Columbia Doctors
      • New York, New York, United States, 10032
        • Audubon Clinic
      • New York, New York, United States, 10032
        • Center for Prenatal Pediatrics
      • New York, New York, United States, 10032
        • Herbert Irving Pavilion
      • New York, New York, United States, 10032
        • Morgan Stanley Childrens Hospital
      • Vestal, New York, United States, 13850
        • Meridian Clinical Research LLC
    • North Carolina
      • Cary, North Carolina, United States, 27519
        • UNC OB/GYN at Panther Creek (recruitment, randomization, administration of IP)
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Children's Hospital (Pediatric follow up)
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Healthcare (recruitment, randomization, administration of IP)
      • Chapel Hill, North Carolina, United States, 27514
        • UNC OB/GYN at Weaver Crossing (recruitment, randomization, administration of IP)
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital
      • Durham, North Carolina, United States, 27704
        • Duke Children's Primary Care - Roxboro Street
      • Durham, North Carolina, United States, 27704
        • Duke Regional Hospital
      • Durham, North Carolina, United States, 27705
        • Duke University.
      • Fort Bragg, North Carolina, United States, 28310
        • Womack Army Medical Center
      • Pinehurst, North Carolina, United States, 28374
        • Firsthealth Moore Regional Hospital
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth Clinical Trials
      • Seven Lakes, North Carolina, United States, 27376
        • Sandhills Pediatrics
      • Southern Pines, North Carolina, United States, 28387
        • Sandhills Pediatrics
      • Southern Pines, North Carolina, United States, 28388
        • FirstHealth Southern Pines Women's Health Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center Department of Obstetrics and Gynecology
      • Dayton, Ohio, United States, 45409
        • Dayton Clinical Research
      • Englewood, Ohio, United States, 45322
        • HWC Women's Research Center, LLC
      • West Chester, Ohio, United States, 45069
        • UC Health West Chester Hospital
    • Oklahoma
      • Yukon, Oklahoma, United States, 73099
        • Integris Yukon Hospital
      • Yukon, Oklahoma, United States, 73099
        • Tekton Research
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16506
        • Allegheny Health and Wellness Pavilion
      • Erie, Pennsylvania, United States, 16508
        • Liberty Family Practice
      • Erie, Pennsylvania, United States, 16507
        • OBGYN Associates of Erie
      • Erie, Pennsylvania, United States, 16544
        • Saint Vincent Hospital
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital - Children's Health Center
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital - Women's Health Center
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital-Family Health Care Center
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Coastal Pediatric Research
      • Charleston, South Carolina, United States, 29414
        • Bon Secours St. Francis Hospital
      • Charleston, South Carolina, United States, 29414
        • Charleston 0B/GYN
      • Greenville, South Carolina, United States, 29605
        • Prisma Health
      • Greenville, South Carolina, United States, 29605
        • Prisma Health-Upstate Office of Maternal Fetal Medicine
      • Summerville, South Carolina, United States, 29485
        • Lowcountry Womens Specialists
      • Summerville, South Carolina, United States, 29485
        • Summerville Medical Center
      • Summerville, South Carolina, United States, 29486
        • Coastal Pediatric Research
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford Obstetrics and Gynecology Clinic (Recruitment, Consenting, IP Administration, and Follow Up)
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford USD Medical Center (Main Hospital)
      • Sioux Falls, South Dakota, United States, 57108
        • Sanford Women's Health Plaza (Recruitment, Consenting, and Follow Up)
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford Obstetrics and Gynecology Clinic
    • Tennessee
      • Clarksville, Tennessee, United States, 37040
        • Premier Medical Group
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Health Arlington Memorial Hospital
      • Arlington, Texas, United States, 76012
        • Ventavia Research Group, LLC
      • Arlington, Texas, United States, 76015
        • Medical City Arlington (Women's Hospital)
      • Austin, Texas, United States, 78705
        • St. David's Medical Center
      • Austin, Texas, United States, 78705
        • Tekton Research, Inc.
      • Beaumont, Texas, United States, 77702
        • Center for Women''s Health and Birthcare
      • Beaumont, Texas, United States, 77702
        • Christus St. Elizabeth Hospital
      • Beaumont, Texas, United States, 77702
        • Gadolin Research, LLC
      • Bedford, Texas, United States, 76022
        • Texas Health Harris Methodist Hospital Hurst-Euless-Bedford
      • Burleson, Texas, United States, 76028
        • Child Care Pediatrics, P.A.
      • Burleson, Texas, United States, 76028
        • Ventavia Research Group LLC
      • Dallas, Texas, United States, 75231
        • Texas Health Presbyterian Hospital Dallas
      • Dallas, Texas, United States, 75231
        • Ventavia Research Group LLC
      • Decatur, Texas, United States, 76243
        • Wise Health System Dectaur
      • Dickinson, Texas, United States, 77539
        • Cline Pediatrics
      • Edinburg, Texas, United States, 78539
        • Doctor's Hospital Womens Hospital
      • Edinburg, Texas, United States, 78539
        • South Texas Health System- Edinburg
      • Fort Worth, Texas, United States, 76104
        • Ventavia Research Group, LLC
      • Fort Worth, Texas, United States, 76104
        • 8th Avenue Obstetrics & Gynecology
      • Fort Worth, Texas, United States, 76104
        • Baylor Scott & White All Saints Medical Center
      • Fort Worth, Texas, United States, 76104
        • Texas Health Harris Methodist Hospital Fort Worth
      • Fort Worth, Texas, United States, 76132
        • Texas Health Harris Methodist Hospital Southwest
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch
      • Georgetown, Texas, United States, 78626
        • Chisholm Trail Pediatrics
      • Georgetown, Texas, United States, 78626
        • St. David's Georgetown Hospital
      • Georgetown, Texas, United States, 78626
        • FMC Science
      • Grapevine, Texas, United States, 76051
        • Baylor Scott & White of Grapevine (Hospital)
      • Grapevine, Texas, United States, 76051
        • Ventavia Research Group, LLC
      • Houston, Texas, United States, 77008
        • Hany H. Ahmed, MD
      • Houston, Texas, United States, 77008
        • HG Pediatrics
      • Houston, Texas, United States, 77008
        • Van Tran Family Clinic
      • Houston, Texas, United States, 77008
        • Ventavia Research Group, LLC
      • Houston, Texas, United States, 77024
        • Memorial Hermann Memorial City
      • Houston, Texas, United States, 77024
        • UT Health Women's Research Center at Memorial City
      • Houston, Texas, United States, 77054
        • HCA: The Women's Hospital of Texas
      • Houston, Texas, United States, 77054
        • Javara Inc.
      • Houston, Texas, United States, 77054
        • Privia Medical Group Gulf Coast, PLLC
      • Houston, Texas, United States, 77081
        • Texas Center for Drug Development, Inc
      • Lampasas, Texas, United States, 76550
        • FMC Science
      • Lampasas, Texas, United States, 76550
        • AdventHealth Family Medicine Rural Health Clinic, Inc.
      • League City, Texas, United States, 77573
        • Maximos Ob/Gyn
      • Longview, Texas, United States, 75605
        • DCOL Center for Clinical Research
      • Longview, Texas, United States, 75605
        • Diagnostic Clinic of Longview (Hollybrook)
      • Longview, Texas, United States, 75605
        • Diagnostic Clinic of Longview (Medical Circle)
      • Longview, Texas, United States, 75605
        • Longview Regional Medical Center
      • McAllen, Texas, United States, 78503
        • Rio Grande Regional Hospital
      • McAllen, Texas, United States, 78503
        • South Texas Health System- McAllen
      • McAllen, Texas, United States, 78504
        • Dr. Ruben Aleman and Associates
      • Plano, Texas, United States, 75093
        • Texas Health Presbyterian Hospital Plano
      • Plano, Texas, United States, 75093
        • Ventavia Research Group LLC
      • Plano, Texas, United States, 75075
        • Medical City Plano
      • San Antonio, Texas, United States, 78229
        • St. Luke's Baptist Hospital
      • San Antonio, Texas, United States, 78229
        • Tekton Research, LLC.
      • Tomball, Texas, United States, 77375
        • DM Clinical Research
      • Weatherford, Texas, United States, 76086
        • Medical City Weatherford
      • Weatherford, Texas, United States, 76086
        • Ventavia Research Group
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital
      • Salt Lake City, Utah, United States, 84107
        • JBR Clinical Research
      • Salt Lake City, Utah, United States, 84102
        • Alpine Medical Group
      • Salt Lake City, Utah, United States, 84107
        • Intermountain Medical Center
      • Salt Lake City, Utah, United States, 84107
        • Old Farm Obstetrics & Gynecology, LLC
      • Salt Lake City, Utah, United States, 84117
        • Holladay Family Practice
      • Salt Lake City, Utah, United States, 84124
        • St. Marks Hospital
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Tidewater Physicians for Women
      • Norfolk, Virginia, United States, 23502
        • Sentara Leigh Hospital
      • Norfolk, Virginia, United States, 23502
        • The Group for Women
      • North Chesterfield, Virginia, United States, 23235
        • Clinical Research Partners, LLC
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth Univeristy Health Systems-Children's Pavilion
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth University Health System-Main Hospital
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth University Health System-Nelson Clinic
      • Richmond, Virginia, United States, 23226
        • Clinical Research Partners, LLC
      • Richmond, Virginia, United States, 23298
        • VCU Health Adult Outpatient Pavillion
      • Virginia Beach, Virginia, United States, 23462
        • Tidewater Physicians for Women
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital
      • Seattle, Washington, United States, 98105
        • UW Neighborhood Ravenna Clinic
      • Seattle, Washington, United States, 98109
        • UW Neighborhood South Lake Union Clinic
      • Seattle, Washington, United States, 98133
        • University of Washington Medical Center - Northwest
      • Seattle, Washington, United States, 98133
        • UW Midwives Clinic at Northwest Outpatient Medical center
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center- Montlake
      • Shoreline, Washington, United States, 98133
        • UW Neighborhood Shoreline Clinic
      • Tacoma, Washington, United States, 98405
        • MultiCare Institute for Research & Innovation
      • Tacoma, Washington, United States, 98405
        • MultiCare Health System - Mary Bridge Children's Health Center
      • Tacoma, Washington, United States, 98405
        • Multicare Health System-Multicare Women's Center Tacoma
      • Tacoma, Washington, United States, 98405
        • Multicare Health System-Pediatrics Northwest
      • Tacoma, Washington, United States, 98405
        • Multicare Health System-Tacoma General Hospital
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Cabell Huntington Hospital
      • Huntington, West Virginia, United States, 25701
        • Marshall Health
      • Huntington, West Virginia, United States, 25701
        • University Physicians and Surgeons dba Marshall Health Department of Obstetrics and Gynecology
      • Huntington, West Virginia, United States, 25701
        • University Physicians and Surgeons dba Marshall Health Department of Pediatrics
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center - Marshfield

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 49 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo dose
Placebo
Biological: Placebo
Placebo
Experimental: RSVpreF vaccine
RSVpreF
Biological: RSVpreF
RSV vaccine (RSVpreF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Infant Participants With Medically Attended Lower Respiratory Tract Illness (MA-LRTI) Cases Due to RSV Occurring Within 90 Days After Birth (Efficacy)
Time Frame: Within 90 days after birth
Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: infant with an MA-RTI visit with age related fast breathing (respiratory rate [RR] more than or equal to [>=] 60 breaths per minute [bpm] for less than [<] 2 months of age [<60 days of age], >=50 bpm for >=2 months to <12 months of age, or >=40 bpm for >=12 months to 24 months of age) or oxygen saturation (SpO2) <95 percent (%) or chest wall indrawing and RSV positive test results by reverse transcription-polymerase chain reaction (RT-PCR) testing of midturbinate nasal swab samples.
Within 90 days after birth
Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 120 Days After Birth (Efficacy)
Time Frame: Within 120 days after birth
Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (RR >=60 bpm for <2 months of age [<60 days of age], >=50 bpm for >=2 months to <12 months of age, or >=40 bpm for >=12 months to 24 months of age) or SpO2 <95% or chest wall indrawing and RSV positive test results by RT-PCR testing of midturbinate nasal swab samples.
Within 120 days after birth
Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 150 Days After Birth (Efficacy)
Time Frame: Within 150 days after birth
Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (RR >=60 bpm for <2 months of age [<60 days of age], >=50 bpm for >=2 months to <12 months of age, or >=40 bpm for >=12 months to 24 months of age) or SpO2 <95% or chest wall indrawing and RSV positive test results by RT-PCR testing of midturbinate nasal swab samples.
Within 150 days after birth
Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 180 Days After Birth (Efficacy)
Time Frame: Within 180 days after birth
Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (RR >=60 bpm for <2 months of age [<60 days of age], >=50 bpm for >=2 months to <12 months of age, or >=40 bpm for >=12 months to 24 months of age) or SpO2 <95% or chest wall indrawing and RSV positive test results by RT-PCR testing of midturbinate nasal swab samples.
Within 180 days after birth
Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 90 Days After Birth (Efficacy)
Time Frame: Within 90 days after birth
Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases included MA-LRTI cases. Severe MA-LRTI case was an RSV positively adjudicated event which met the following defined criteria: an infant with an MA-RTI visit and aged associated fast breathing (RR >=70 bpm for <2 months of age [<60 days of age], >=60 bpm for >=2 months to <12 months of age, or >=50 bpm for >=12 months to 24 months of age) or SpO2 <93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or non-invasive) or intensive care unit (ICU) admission for more than (>) 4 hours or failure to respond/unconscious.
Within 90 days after birth
Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 120 Days After Birth (Efficacy)
Time Frame: Within 120 days after birth
Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases were included MA-LRTI cases. Severe MA-LRTI case was an RSV positively adjudicated event which met the following defined criteria: an infant with an MA-RTI visit and aged associated fast breathing (RR >=70 bpm for <2 months of age [<60 days of age], >=60 bpm for >=2 months to <12 months of age, or >=50 bpm for >=12 months to 24 months of age) or SpO2 <93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or non-invasive) or ICU admission for >4 hours or failure to respond/unconscious.
Within 120 days after birth
Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 150 Days After Birth (Efficacy)
Time Frame: Within 150 days after birth
Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases were included MA-LRTI cases. Severe MA-LRTI case was an RSV positively adjudicated event which met the following defined criteria: an infant with an MA-RTI visit and aged associated fast breathing (RR >=70 bpm for <2 months of age [<60 days of age], >=60 bpm for >=2 months to <12 months of age, or >=50 bpm for >=12 months to 24 months of age) or SpO2 <93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or non-invasive) or ICU admission for >4 hours or failure to respond/unconscious.
Within 150 days after birth
Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 180 Days After Birth (Efficacy)
Time Frame: Within 180 days after birth
Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases were included MA-LRTI cases. Severe MA-LRTI case was an RSV positively adjudicated event which met the following defined criteria: an infant with an MA-RTI visit and aged associated fast breathing (RR >=70 bpm for <2 months of age [<60 days of age], >=60 bpm for >=2 months to <12 months of age, or >=50 bpm for >=12 months to 24 months of age) or SpO2 <93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or non-invasive) or ICU admission for >4 hours or failure to respond/unconscious.
Within 180 days after birth
Percentage of Infant Participants With Adverse Events of Special Interest (AESI) (Safety)
Time Frame: From birth to 24 months of age
AESI are a subset of targeted medical events based on review of known pharmacology, toxicology findings, possible class effects, published literature, and signals arising from safety data assessments, and on population under study. AESIs were based on targeted medical events associated with pregnant maternal participants and their infants prior to/during delivery and at birth. For infant participants the following were considered as protocol defined AESIs: Preterm birth (born at <37 weeks gestation); birth weight 1001-2500 grams; developmental delay; positive viral (polymerase chain reaction [PCR] or antigen-based) testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), when not reported during MA-RTI visit, were reported as SARS-CoV-2 test positive. Extremely preterm birth (<28 weeks) and extremely low birth weight (=<1000 grams [g]) were reported as serious AESIs.
From birth to 24 months of age
Percentage of Infant Participants With Neonatal Deaths (Safety)
Time Frame: Within 1 Month after birth
Neonatal death was defined as the death of a live-born infant that occurred within a month after birth.
Within 1 Month after birth
Percentage of Infant Participants With Congenital Malformations/Anomalies (Safety)
Time Frame: At birth
Congenital malformations/ anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life.
At birth
Percentage of Infant Participants With Other Neonatal Events (Safety)
Time Frame: Within 1 Month after birth
Other Neonatal problem included dysmaturity, neonatal illness, hospitalization, drug therapies, and neonatal death.
Within 1 Month after birth
Number of Infant Participants According to Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute After Birth (Safety)
Time Frame: 1 minute after birth
APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor.
1 minute after birth
Number of Infant Participants According to APGAR Score at 5 Minutes After Birth (Safety)
Time Frame: 5 minutes after birth
APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor.
5 minutes after birth
Number of Infant Participants According to APGAR Score at 10 Minutes After Birth (Safety)
Time Frame: 10 minutes after birth
APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor.
10 minutes after birth
Percentage of Infant Participants With Adverse Events (AEs) From Birth to 1 Month of Age (Safety)
Time Frame: From birth to 1 month of age
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
From birth to 1 month of age
Percentage of Infant Participants With Serious Adverse Events (SAEs) and Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Birth Through 6 Months of Age (Safety)
Time Frame: From birth to 6 months of age
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
From birth to 6 months of age
Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 12 Months of Age (Safety)
Time Frame: From birth to 12 months of age
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
From birth to 12 months of age
Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 24 Months of Age (Safety)
Time Frame: From birth to 24 months of age
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
From birth to 24 months of age
Percentage of Maternal Participants With Prespecified Local Reactions Within 7 Days After Vaccination (Safety)
Time Frame: From Day 1 to Day 7 after vaccination
Local reactions included redness, swelling, and pain at injection site and were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit= 0.5 centimetre (cm). Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization for the severe pain at the injection site). Grade 4 reactions were classified by the investigator or medically qualified person.
From Day 1 to Day 7 after vaccination
Percentage of Maternal Participants With Prespecified Systemic Events Within 7 Days After Vaccination (Safety)
Time Frame: From Day 1 to Day 7 after vaccination
Systemic events included: fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting and diarrhea and were recorded by participants in an e-diary. Fever was defined as an oral temperature >=38.0 degree Celsius [C]) and classified as mild (38.0 to 38.4), moderate (38.5 to 38.9), severe (39.0 to 40.0) and grade 4 (>40.0 degree C). Headache, nausea, fatigue, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily activity). Vomiting: mild (1-2 times in 24 hours [H]), moderate (>2 times in 24 H), severe (required intravenous [IV] hydration). Diarrhea: mild (2-3 loose stools in 24 H), moderate (4-5 loose stools in 24 H), severe (>=6 in 24 H). For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by investigator or medically qualified person.
From Day 1 to Day 7 after vaccination
Percentage of Maternal Participants With AEs From the Time of Vaccination Through 1 Month After Vaccination (Safety)
Time Frame: From vaccination on Day 1 up to 1 month after vaccination
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included in this outcome measure.
From vaccination on Day 1 up to 1 month after vaccination
Percentage of Maternal Participants With SAEs Throughout the Study Period (Safety)
Time Frame: From vaccination on Day 1 up to 6 months after delivery (maximum up to 10 months)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event.
From vaccination on Day 1 up to 6 months after delivery (maximum up to 10 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Infant Participants With Cases of Hospitalization Due to RSV Within 90, 120, 150, 180 and 360 Days After Birth (Efficacy)
Time Frame: Within 90, 120, 150, 180 and 360 days after birth
Results are reported as confirmed by endpoint adjudication committee.
Within 90, 120, 150, 180 and 360 days after birth
Percentage of Infant Participants With MA-LRTI Cases Due to Any Cause With Protocol Defined Criteria Occurring Within 90, 120, 150, 180 and 360 Days After Birth (Efficacy)
Time Frame: Within 90, 120, 150, 180 and 360 days after birth
MA-LRTI cases due to any cause was defined as an infant with a MA-RTI visit with age related fast breathing (RR >=60 bpm for <2 months of age [<60 days of age], >=50 bpm for >=2 months to <12 months of age, or >=40 bpm for >=12 months to 24 months of age) or SpO2 <95% or chest wall indrawing.
Within 90, 120, 150, 180 and 360 days after birth
Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 210, 240, 270 and 360 Days After Birth (Efficacy)
Time Frame: Within 210, 240, 270 and 360 days after birth
Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (RR >=60 bpm for <2 months of age [<60 days of age], >=50 bpm for >=2 months to <12 months of age, or >=40 bpm for >=12 months to 24 months of age) or SpO2 <95% or chest wall indrawing and RSV positive test results by RT-PCR testing of midturbinate nasal swab samples.
Within 210, 240, 270 and 360 days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2020

Primary Completion (Actual)

October 27, 2023

Study Completion (Actual)

October 27, 2023

Study Registration Dates

First Submitted

June 3, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 17, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C3671008
  • 2019-002943-85 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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