A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose
NCT ID: NCT06866405
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
550 participants
INTERVENTIONAL
2025-04-16
2028-02-24
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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RSVpreF
RSVpreF
Single Dose
Placebo
Placebo
Single Dose
Interventions
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RSVpreF
Single Dose
Placebo
Single Dose
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
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.
* 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.
0 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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 (inpatient hospital)
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
Emerald Coast Pediatrics
Panama City Beach, 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
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 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 Regional Hospital
Durham, North Carolina, 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
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
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
Into Research
Pretoria, Gauteng, South Africa
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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Marguerite
Identifier Type: OTHER
Identifier Source: secondary_id
C3671059
Identifier Type: -
Identifier Source: org_study_id