A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose
Start Date
4/16/2025
Completion Date
2/24/2028
Summary
This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose given during a previous pregnancy by examining the blood of nonpregnant participants who had the vaccine before.
Detailed Description
This study will include pregnant participants and their unborn babies (Cohort 1 and Cohort 2) and non-pregnant participants (Cohort 3), as described below: * Cohort 1- Pregnant participants who had previously received RSVpreF as part of a Pfizer clinical trial and have antibody data available from that trial will get a second dose of RSVpreF. * Cohort 2- Pregnant participants who received the RSVpreF in a previous pregnancy, either through commercial means with Abrysvo® or as part of a Pfizer clinical trial, will be randomly chosen to get either one dose of the RSVpreF or one dose of a placebo. This applies to those who do not have antibody data available from the earlier trial. For both groups of pregnant participants, the study will look at how safe and well-tolerated the vaccine is during pregnancy, as well as how the body responds to it. Infants will be monitored for six months after birth to check safety and antibodies level. • Cohort 3- Nonpregnant participants who received RSVpreF during a previous pregnancy as part of an earlier clinical trial will have blood samples taken to see how well their immune response has persisted over time. Participants will not receive any vaccine.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
RSVpreF
Placebo
Conditions
Locations
Center for Research in Women's Health
Birmingham, Alabama 35233
United States
Children's of Alabama
Birmingham, Alabama 35233
United States
University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama 35233
United States
University of Alabama at Birmingham Women & Infants Center
Birmingham, Alabama 35233
United States
USA Health Children's and Women's Hospital
Mobile, Alabama 36604
United States
USA Health Strada Patient Care Center
Mobile, Alabama 36604
United States
Ronald Reagan UCLA Medical Center
Los Angeles, California 90024
United States
Ronald Reagan UCLA Medical Center (inpatient hospital)
Los Angeles, California 90095
United States
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
United States
UCLA (outpatient clinic)
Los Angeles, California 90095
United States
UCLA Clinical and Translational Research Center (research clinic)
Los Angeles, California 90095
United States
UCLA
Los Angeles, California 90095
United States
Lucile Packard Children's Hospital-Labor and Delivery Unit
Palo Alto, California 94304
United States
Stanford Obstetrics Clinic
Palo Alto, California 94304
United States
Stanford University Medical Center
Palo Alto, California 94304
United States
Stanford University
Palo Alto, California 94304
United States
Anschutz Health Sciences Building (AHSB)
Aurora, Colorado 80045
United States
Children's Hospital Colorado
Aurora, Colorado 80045
United States
CU Research Pharmacy
Aurora, Colorado 80045
United States
University of Colorado AO1 UCH
Aurora, Colorado 80045
United States
University of Colorado Hospital Inpatient Pavilion
Aurora, Colorado 80045
United States
University of Colorado Hospital Outpatient Pavilion
Aurora, Colorado 80045
United States
University of Colorado Research II Building
Aurora, Colorado 80045
United States
Citadelle Clinical Research
North Miami Beach, Florida 33162
United States
Emerald Coast OBGYN Clinical Research
Panama City, Florida 32405
United States
Emerald Coast Pediatrics
Panama City, Florida 32405
United States
HCA Florida Gulf Coast Hospital
Panama City, Florida 32405
United States
Advanced Specialty Research
Boise, Idaho 83702
United States
Saint Alphonsus Regional Medical Center
Boise, Idaho 83706
United States
St. Luke's Boise Medical Center
Boise, Idaho 83712
United States
Clinical Research Prime
Idaho Falls, Idaho 83404
United States
Saint Alphonsus Medical Center
Nampa, Idaho 83687
United States
St. Luke's Nampa Medical Center
Nampa, Idaho 83687
United States
Accellacare - McFarland
Ames, Iowa 50010
United States
Mary Greeley Medical Center
Ames, Iowa 50010
United States
McFarland Clinic, PC
Ames, Iowa 50010
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Velocity Clinical Research, Lafayette
Lafayette, Louisiana 70508
United States
Velocity Clinical Research - New Orleans
New Orleans, Louisiana 70119
United States
Boston Medical Center
Boston, Massachusetts 02118
United States
Velocity Clinical Research, Gulfport
Gulfport, Mississippi 39503
United States
Boeson Research GTF
Great Falls, Montana 59405
United States
OBGYN Associates
Great Falls, Montana 59405
United States
Boeson Research KAL
Kalispell, Montana 59901
United States
Heart & Hands Midwifery
Kalispell, Montana 59901
United States
Boeson Research Laboratory
Missoula, Montana 59804
United States
Boeson Research MSO
Missoula, Montana 59804
United States
Origin Health
Missoula, Montana 59804
United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska 68803
United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska 68701
United States
Presbyterian Hospital
Albuquerque, New Mexico 87107
United States
UNM Hospital
Albuquerque, New Mexico 87107
United States
Velocity Clinical Research, Albuquerque
Albuquerque, New Mexico 87107
United States
Lovelace Women's Hospital
Albuquerque, New Mexico 87109
United States
Duke University - Main Hospital and Clinics
Durham, North Carolina 27705
United States
Duke University - Main Hospital and Clinics
Durham, North Carolina 27710
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
Prisma Health-Upstate
Greenville, South Carolina 29605
United States
Prisma Health
Greenville, South Carolina 29605
United States
Memorial Hermann Memorial City Hospital
Houston, Texas 77024
United States
The University of Texas Health Science Center at Houston
Houston, Texas 77204
United States
Helios Clinical Research - WEA
Weatherford, Texas 76086
United States
Medical City Weatherford
Weatherford, Texas 76086
United States
Weatherford OB/GYN Associates
Weatherford, Texas 76086
United States
University of Utah Obstetrics and Gynecology Research Offices
Salt Lake City, Utah 84108
United States
University of Utah Madsen Health Center - Women's Health
Salt Lake City, Utah 84112
United States
University of Utah
Salt Lake City, Utah 84112
United States
University of Utah Clinical Neuroscience Center
Salt Lake City, Utah 84132
United States
University of Utah Hospital
Salt Lake City, Utah 84132
United States
University of Utah
Salt Lake City, Utah 84132
United States
Sentara Leigh Hospital
Norfolk, Virginia 23502
United States
The Group For Women - Kempsville Office
Norfolk, Virginia 23502
United States
Tidewater Physicians for Women
Norfolk, Virginia 23502
United States
WomensCare Center
Norfolk, Virginia 23502
United States
Virginia Physicians For Women (VPFW)
North Chesterfield, Virginia 23235
United States
Clinical Research Partners, LLC
Richmond, Virginia 23226
United States
Infusion Solutions, LLC
Richmond, Virginia 23226
United States
Seattle Children's Research Institute
Seattle, Washington 98101
United States
Seattle Children's Hospital
Seattle, Washington 98105
United States
University of Washington - Northwest
Seattle, Washington 98133
United States
University of Washington Medical Center - Montlake
Seattle, Washington 98195
United States
Fundación Respirar
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ABP
Argentina
Clinica Del Niño Y La Madre
Mar del Plata, Buenos Aires 7600
Argentina
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, Tucumán Province 4000
Argentina
Instituto de Maternidad y Ginecología Nuestra Señora de las Mercedes
San Miguel de Tucumán, Tucumán Province 4000
Argentina
Centro de investigación Clínica OSECAC - Sede Jonas Salk
Buenos Aires, 1044
Argentina
Equipo Ciencia
Buenos Aires, C1428BNF
Argentina
Hospital Público Materno Infantil
Salta, 4400
Argentina
Josha Research
Bloemfontein, Free State 9301
South Africa
University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)
Johannesburg, Gauteng 1864
South Africa
Wits RHI
Johannesburg, Gauteng 2001
South Africa
Setshaba Research Centre
Pretoria, Gauteng 0152
South Africa
Into Research
Pretoria, Gauteng 0181
South Africa
Family Clinical Research Unit (Fam-Cru)
Cape Town, Western Cape 7500
South Africa
MRC Unit on Child And Adolescent Health
Cape Town, Western Cape 7700
South Africa
University of Cape Town Lung Institute (Pty) Ltd
Cape Town, Western Cape 7700
South Africa
Medical Research Council Unit
Banjul, Fajara PO Box 273
The Gambia