🔎 Trials Near Me

Home › Respiratory Syncytial Virus Infections › NCT06866405

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

RecruitingPhase 3Healthy volunteers welcome

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.

Who can join

Ages 0 and older · All sexes · Healthy volunteers welcome

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Pfizer · Participants: 550 · Started: Apr 16, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06866405

Locations in the U.S.

AlabamaCenter for Research in Women's Health, Birmingham
Children's of Alabama, Birmingham
University of Alabama at Birmingham - School of Medicine, Birmingham
University of Alabama at Birmingham Women & Infants Center, Birmingham
USA Health Children's and Women's Hospital, Mobile
USA Health Strada Patient Care Center, Mobile
ArizonaClinMed, LLC, Phoenix
CaliforniaRonald Reagan UCLA Medical Center, Los Angeles
Ronald Reagan UCLA Medical Center, Los Angeles
Ronald Reagan UCLA Medical Center (inpatient hospital), Los Angeles
UCLA, Los Angeles
UCLA (outpatient clinic), Los Angeles
UCLA Clinical and Translational Research Center (research clinic), Los Angeles
Lucile Packard Children's Hospital-Labor and Delivery Unit, Palo Alto
Stanford Obstetrics Clinic, Palo Alto
Stanford University, Palo Alto
Stanford University Medical Center, Palo Alto
ColoradoAnschutz Health Sciences Building (AHSB), Aurora
CU Research Pharmacy, Aurora
Children's Hospital Colorado, Aurora
University of Colorado AO1 UCH, Aurora
University of Colorado Hospital Inpatient Pavilion, Aurora
University of Colorado Hospital Outpatient Pavilion, Aurora
University of Colorado Research II Building, Aurora
FloridaCitadelle Clinical Research, North Miami Beach
Emerald Coast OBGYN Clinical Research, Panama City
Emerald Coast Pediatrics, Panama City
HCA Florida Gulf Coast Hospital, Panama City
IdahoAdvanced Specialty Research, Boise
Saint Alphonsus Regional Medical Center, Boise
St. Luke's Boise Medical Center, Boise
Clinical Research Prime, Idaho Falls
Saint Alphonsus Medical Center, Nampa
St. Luke's Nampa Medical Center, Nampa
IowaAccellacare - McFarland, Ames
Mary Greeley Medical Center, Ames
McFarland Clinic, PC, Ames
KansasUniversity of Kansas Medical Center, Kansas City
LouisianaVelocity Clinical Research - New Orleans, New Orleans
MassachusettsBoston Medical Center, Boston
MississippiVelocity Clinical Research, Gulfport, Gulfport
MontanaBoeson Research GTF, Great Falls
OBGYN Associates, Great Falls
Boeson Research KAL, Kalispell
Heart & Hands Midwifery, Kalispell
Boeson Research Laboratory, Missoula
Boeson Research MSO, Missoula
Origin Health, Missoula
NebraskaVelocity Clinical Research, Grand Island, Grand Island
Velocity Clinical Research, Norfolk, Norfolk
New MexicoLovelace Women's Hospital, Albuquerque
Presbyterian Hospital, Albuquerque
UNM Hospital, Albuquerque
Velocity Clinical Research, Albuquerque, Albuquerque
North CarolinaDuke University - Main Hospital and Clinics, Durham
Duke University - Main Hospital and Clinics, Durham
OhioCincinnati Children's Hospital Medical Center, Cincinnati
South CarolinaPrisma Health Maternal Fetal Medicine, Greenville
Prisma Health OBGYN Center, Greenville
TexasMemorial Hermann Memorial City Hospital, Houston
The University of Texas Health Science Center at Houston, Houston
Helios Clinical Research - WEA, Weatherford
Medical City Weatherford, Weatherford
Weatherford OB/GYN Associates, Weatherford
UtahUniversity of Utah, Salt Lake City
University of Utah, Salt Lake City
University of Utah Clinical Neuroscience Center, Salt Lake City
University of Utah Madsen Health Center - Women's Health, Salt Lake City
University of Utah Obstetrics and Gynecology Research Offices, Salt Lake City
VirginiaSentara Leigh Hospital, Norfolk
The Group For Women - Kempsville Office, Norfolk
Tidewater Physicians for Women, Norfolk
WomensCare Center, Norfolk
Virginia Physicians For Women (VPFW), North Chesterfield
Clinical Research Partners, LLC, Richmond
Infusion Solutions, LLC, Richmond
WashingtonSeattle Children's Hospital, Seattle
Seattle Children's Research Institute, Seattle
University of Washington - Northwest, Seattle
University of Washington Medical Center - Montlake, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.