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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
- RSVpreF (biological)
- Placebo (biological)
Sponsor: Pfizer · Participants: 550 · Started: Apr 16, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT06866405
Locations in the U.S.
| Alabama | Center 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 |
| Arizona | ClinMed, LLC, Phoenix |
| California | Ronald 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 |
| Colorado | Anschutz 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 |
| Florida | Citadelle Clinical Research, North Miami Beach Emerald Coast OBGYN Clinical Research, Panama City Emerald Coast Pediatrics, Panama City HCA Florida Gulf Coast Hospital, Panama City |
| Idaho | Advanced 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 |
| Iowa | Accellacare - McFarland, Ames Mary Greeley Medical Center, Ames McFarland Clinic, PC, Ames |
| Kansas | University of Kansas Medical Center, Kansas City |
| Louisiana | Velocity Clinical Research - New Orleans, New Orleans |
| Massachusetts | Boston Medical Center, Boston |
| Mississippi | Velocity Clinical Research, Gulfport, Gulfport |
| Montana | Boeson 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 |
| Nebraska | Velocity Clinical Research, Grand Island, Grand Island Velocity Clinical Research, Norfolk, Norfolk |
| New Mexico | Lovelace Women's Hospital, Albuquerque Presbyterian Hospital, Albuquerque UNM Hospital, Albuquerque Velocity Clinical Research, Albuquerque, Albuquerque |
| North Carolina | Duke University - Main Hospital and Clinics, Durham Duke University - Main Hospital and Clinics, Durham |
| Ohio | Cincinnati Children's Hospital Medical Center, Cincinnati |
| South Carolina | Prisma Health Maternal Fetal Medicine, Greenville Prisma Health OBGYN Center, Greenville |
| Texas | Memorial 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 |
| Utah | University 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 |
| Virginia | Sentara 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 |
| Washington | Seattle 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.