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RecruitingPhase 3NCT06866405

A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose

A Phase 3 Study to Investigate the Safety, Tolerability, and Immunogenicity of Revaccinating Pregnant Participants During Subsequent Pregnancies and Persistence of Immunity of a Single Dose of a Bivalent Respiratory Syncytial Virus (RSV) Vaccine.

Sponsor

Pfizer

Enrollment

550 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

RSV Infection

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.

Eligibility

Min Age: 0 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Placebo and a biological treatment called RSVpreF for people with rsv infection. The study is currently recruiting participants at 95 locations. People eligible for this study include aged 0 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRSVpreF

Single Dose

BIOLOGICALPlacebo

Single Dose

Locations(97)

Center for Research in Women's Health

Birmingham, Alabama, United States

Children's of Alabama

Birmingham, Alabama, United States

University of Alabama at Birmingham - School of Medicine

Birmingham, Alabama, United States

University of Alabama at Birmingham Women & Infants Center

Birmingham, Alabama, United States

USA Health Children's and Women's Hospital

Mobile, Alabama, United States

USA Health Strada Patient Care Center

Mobile, Alabama, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Ronald Reagan UCLA Medical Center (inpatient hospital)

Los Angeles, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

UCLA (outpatient clinic)

Los Angeles, California, United States

UCLA Clinical and Translational Research Center (research clinic)

Los Angeles, California, United States

UCLA

Los Angeles, California, United States

Lucile Packard Children's Hospital-Labor and Delivery Unit

Palo Alto, California, United States

Stanford Obstetrics Clinic

Palo Alto, California, United States

Stanford University Medical Center

Palo Alto, California, United States

Stanford University

Palo Alto, California, United States

Anschutz Health Sciences Building (AHSB)

Aurora, Colorado, United States

Children's Hospital Colorado

Aurora, Colorado, United States

CU Research Pharmacy

Aurora, Colorado, United States

University of Colorado AO1 UCH

Aurora, Colorado, United States

University of Colorado Hospital Inpatient Pavilion

Aurora, Colorado, United States

University of Colorado Hospital Outpatient Pavilion

Aurora, Colorado, United States

University of Colorado Research II Building

Aurora, Colorado, United States

Citadelle Clinical Research

North Miami Beach, Florida, United States

Emerald Coast OBGYN Clinical Research

Panama City, Florida, United States

Emerald Coast Pediatrics

Panama City, Florida, United States

HCA Florida Gulf Coast Hospital

Panama City, Florida, United States

Advanced Specialty Research

Boise, Idaho, United States

Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

St. Luke's Boise Medical Center

Boise, Idaho, United States

Clinical Research Prime

Idaho Falls, Idaho, United States

Saint Alphonsus Medical Center

Nampa, Idaho, United States

St. Luke's Nampa Medical Center

Nampa, Idaho, United States

Accellacare - McFarland

Ames, Iowa, United States

Mary Greeley Medical Center

Ames, Iowa, United States

McFarland Clinic, PC

Ames, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Velocity Clinical Research, Lafayette

Lafayette, Louisiana, United States

Velocity Clinical Research - New Orleans

New Orleans, Louisiana, United States

Boston Medical Center

Boston, Massachusetts, United States

Velocity Clinical Research, Gulfport

Gulfport, Mississippi, United States

Boeson Research GTF

Great Falls, Montana, United States

OBGYN Associates

Great Falls, Montana, United States

Boeson Research KAL

Kalispell, Montana, United States

Heart & Hands Midwifery

Kalispell, Montana, United States

Boeson Research Laboratory

Missoula, Montana, United States

Boeson Research MSO

Missoula, Montana, United States

Origin Health

Missoula, Montana, United States

Velocity Clinical Research, Grand Island

Grand Island, Nebraska, United States

Velocity Clinical Research, Norfolk

Norfolk, Nebraska, United States

Presbyterian Hospital

Albuquerque, New Mexico, United States

UNM Hospital

Albuquerque, New Mexico, United States

Velocity Clinical Research, Albuquerque

Albuquerque, New Mexico, United States

Lovelace Women's Hospital

Albuquerque, New Mexico, United States

Duke University - Main Hospital and Clinics

Durham, North Carolina, United States

Duke University - Main Hospital and Clinics

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Prisma Health-Upstate

Greenville, South Carolina, United States

Prisma Health

Greenville, South Carolina, United States

Memorial Hermann Memorial City Hospital

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Helios Clinical Research - WEA

Weatherford, Texas, United States

Medical City Weatherford

Weatherford, Texas, United States

Weatherford OB/GYN Associates

Weatherford, Texas, United States

University of Utah Obstetrics and Gynecology Research Offices

Salt Lake City, Utah, United States

University of Utah Madsen Health Center - Women's Health

Salt Lake City, Utah, United States

University of Utah

Salt Lake City, Utah, United States

University of Utah Clinical Neuroscience Center

Salt Lake City, Utah, United States

University of Utah Hospital

Salt Lake City, Utah, United States

University of Utah

Salt Lake City, Utah, United States

Sentara Leigh Hospital

Norfolk, Virginia, United States

The Group For Women - Kempsville Office

Norfolk, Virginia, United States

Tidewater Physicians for Women

Norfolk, Virginia, United States

WomensCare Center

Norfolk, Virginia, United States

Virginia Physicians For Women (VPFW)

North Chesterfield, Virginia, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Infusion Solutions, LLC

Richmond, Virginia, United States

Seattle Children's Research Institute

Seattle, Washington, United States

Seattle Children's Hospital

Seattle, Washington, United States

University of Washington - Northwest

Seattle, Washington, United States

University of Washington Medical Center - Montlake

Seattle, Washington, United States

Fundación Respirar

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Clinica Del Niño Y La Madre

Mar del Plata, Buenos Aires, Argentina

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

San Miguel de Tucumán, Tucumán Province, Argentina

Instituto de Maternidad y Ginecología Nuestra Señora de las Mercedes

San Miguel de Tucumán, Tucumán Province, Argentina

Centro de investigación Clínica OSECAC - Sede Jonas Salk

Buenos Aires, Argentina

Equipo Ciencia

Buenos Aires, Argentina

Hospital Público Materno Infantil

Salta, Argentina

Josha Research

Bloemfontein, Free State, South Africa

University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)

Johannesburg, Gauteng, South Africa

Wits RHI

Johannesburg, Gauteng, South Africa

Setshaba Research Centre

Pretoria, Gauteng, South Africa

Into Research

Pretoria, Gauteng, South Africa

Family Clinical Research Unit (Fam-Cru)

Cape Town, Western Cape, South Africa

MRC Unit on Child And Adolescent Health

Cape Town, Western Cape, South Africa

University of Cape Town Lung Institute (Pty) Ltd

Cape Town, Western Cape, South Africa

Medical Research Council Unit

Banjul, Fajara, The Gambia

View Full Details on ClinicalTrials.gov

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NCT06866405

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