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NCT06866405PHASE3RecruitingAccepts Healthy Volunteers

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

Pfizer

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

Pregnant Participants-Cohort 1 and Cohort 2 Key Inclusion Criteria * Women aged 18 to 49 who are pregnant, between 24 and 36 weeks along, and expecting one baby without known risks for complications can participate. * Had the RSVpreF or Abrysvo vaccine during a previous pregnancy. * Had an ultrasound scan at 18 weeks or later during their current pregnancy, with no major fetal problems detected. * Based on their medical history, physical check-up, and the doctor's judgment, they are found suitable to join the study. * Agrees to let their baby take part in the study and gives their permission. * Able to sign a consent form, agreeing to follow the rules and conditions of the study. Key Exclusion Criteria * Received any approved or experimental RSV vaccine since their previous pregnancy. * Has a pre-pregnancy body mass index (BMI) over 40 kg/m2. * History of a severe bad reaction to a vaccine or a serious allergic reaction (like anaphylaxis) to any ingredient in the study vaccine or a similar vaccine. * Current pregnancy problems or issues at the time of giving consent. * Previous pregnancy issues or problems at the time of giving consent. * Women who are breastfeeding at the time of enrollment Infant Participants * Proof that the parent(s) or legal guardian(s) has signed and dated a consent form. * Parent(s) or legal guardian(s) must agree to attend scheduled visits and follow the study plan, including laboratory tests and other procedures. Nonpregnant Participants-Cohort 3 Key Inclusion Criteria * Have already received one dose of the RSVpreF vaccine during their previous pregnancy as part of the Pfizer clinical trial, and the results from that time can be used for this study. * Able to sign a consent form, agreeing to follow the rules and requirements of the study. Key Exclusion Criteria * Received any approved or experimental RSV vaccine after participating in the Pfizer clinical trial. * Taking part in other studies with new drugs within 28 days before giving consent or during the study period.

Interventions

BIOLOGICAL

RSVpreF

BIOLOGICAL

Placebo

Interested in This Trial?

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Conditions

RSV Infection

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