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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Pfizer
Study ID
NCT06866405
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • RSV Infection

Eligibility Criteria

Sex
ALL
Age
0 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • RSVpreF — BIOLOGICAL
    Single Dose
  • Placebo — BIOLOGICAL
    Single Dose

Study Details

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.

Key Dates

Start date
Apr 16, 2025
Status verified
Jun 2026
Primary completion
Feb 24, 2028
Completion
Feb 24, 2028

Study Design

Enrollment
550 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: RSVpreF
  • Placebo Comparator: Placebo

Primary Outcome Measure

Percentage of pregnant participants reporting local reactions [ Time Frame: From Day 1 Through at least Day 7 after Vaccination ]

Central Contacts

Locations (81)

FacilityCityStateZIPSite coordinators
Center for Research in Women's HealthBirminghamAlabama35233-
Children's of AlabamaBirminghamAlabama35233-
University of Alabama at Birmingham - School of MedicineBirminghamAlabama35233-
University of Alabama at Birmingham Women & Infants CenterBirminghamAlabama35233-
USA Health Children's and Women's HospitalMobileAlabama36604-
USA Health Strada Patient Care CenterMobileAlabama36604-
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90024-
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90095-
Ronald Reagan UCLA Medical Center (inpatient hospital)Los AngelesCalifornia90095-
UCLALos AngelesCalifornia90095-
UCLA (outpatient clinic)Los AngelesCalifornia90095-
UCLA Clinical and Translational Research Center (research clinic)Los AngelesCalifornia90095-
Lucile Packard Children's Hospital-Labor and Delivery UnitPalo AltoCalifornia94304-
Stanford Obstetrics ClinicPalo AltoCalifornia94304-
Stanford UniversityPalo AltoCalifornia94304-
Stanford University Medical CenterPalo AltoCalifornia94304-
Anschutz Health Sciences Building (AHSB)AuroraColorado80045-
Children's Hospital ColoradoAuroraColorado80045-
CU Research PharmacyAuroraColorado80045-
University of Colorado AO1 UCHAuroraColorado80045-
University of Colorado Hospital Inpatient PavilionAuroraColorado80045-
University of Colorado Hospital Outpatient PavilionAuroraColorado80045-
University of Colorado Research II BuildingAuroraColorado80045-
Citadelle Clinical ResearchNorth Miami BeachFlorida33162-
Emerald Coast OBGYN Clinical ResearchPanama CityFlorida32405-
Emerald Coast PediatricsPanama CityFlorida32405-
HCA Florida Gulf Coast HospitalPanama CityFlorida32405-
Advanced Specialty ResearchBoiseIdaho83702-
Saint Alphonsus Regional Medical CenterBoiseIdaho83706-
St. Luke's Boise Medical CenterBoiseIdaho83712-
Clinical Research PrimeIdaho FallsIdaho83404-
Saint Alphonsus Medical CenterNampaIdaho83687-
St. Luke's Nampa Medical CenterNampaIdaho83687-
Accellacare - McFarlandAmesIowa50010-
Mary Greeley Medical CenterAmesIowa50010-
McFarland Clinic, PCAmesIowa50010-
University of Kansas Medical CenterKansas CityKansas66160-
Velocity Clinical Research, LafayetteLafayetteLouisiana70508-
Velocity Clinical Research - New OrleansNew OrleansLouisiana70119-
Boston Medical CenterBostonMassachusetts02118-
Velocity Clinical Research, GulfportGulfportMississippi39503-
Boeson Research GTFGreat FallsMontana59405-
OBGYN AssociatesGreat FallsMontana59405-
Boeson Research KALKalispellMontana59901-
Heart & Hands MidwiferyKalispellMontana59901-
Boeson Research LaboratoryMissoulaMontana59804-
Boeson Research MSOMissoulaMontana59804-
Origin HealthMissoulaMontana59804-
Velocity Clinical Research, Grand IslandGrand IslandNebraska68803-
Velocity Clinical Research, NorfolkNorfolkNebraska68701-
Lovelace Women's HospitalAlbuquerqueNew Mexico87109-
Presbyterian HospitalAlbuquerqueNew Mexico87107-
UNM HospitalAlbuquerqueNew Mexico87107-
Velocity Clinical Research, AlbuquerqueAlbuquerqueNew Mexico87107-
Duke University - Main Hospital and ClinicsDurhamNorth Carolina27705-
Duke University - Main Hospital and ClinicsDurhamNorth Carolina27710-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Prisma HealthGreenvilleSouth Carolina29605-
Prisma Health-UpstateGreenvilleSouth Carolina29605-
Memorial Hermann Memorial City HospitalHoustonTexas77024-
The University of Texas Health Science Center at HoustonHoustonTexas77204-
Helios Clinical Research - WEAWeatherfordTexas76086-
Medical City WeatherfordWeatherfordTexas76086-
Weatherford OB/GYN AssociatesWeatherfordTexas76086-
University of UtahSalt Lake CityUtah84112-
University of UtahSalt Lake CityUtah84132-
University of Utah Clinical Neuroscience CenterSalt Lake CityUtah84132-
University of Utah HospitalSalt Lake CityUtah84132-
University of Utah Madsen Health Center - Women's HealthSalt Lake CityUtah84112-
University of Utah Obstetrics and Gynecology Research OfficesSalt Lake CityUtah84108-
Sentara Leigh HospitalNorfolkVirginia23502-
The Group For Women - Kempsville OfficeNorfolkVirginia23502-
Tidewater Physicians for WomenNorfolkVirginia23502-
WomensCare CenterNorfolkVirginia23502-
Virginia Physicians For Women (VPFW)North ChesterfieldVirginia23235-
Clinical Research Partners, LLCRichmondVirginia23226-
Infusion Solutions, LLCRichmondVirginia23226-
Seattle Children's HospitalSeattleWashington98105-
Seattle Children's Research InstituteSeattleWashington98101-
University of Washington - NorthwestSeattleWashington98133-
University of Washington Medical Center - MontlakeSeattleWashington98195-

Find similar trials in Birmingham, AL

By research site
Center for Research in Women's Health· Birmingham, ALChildren's of Alabama· Birmingham, ALUniversity of Alabama at Birmingham - School of Medicine· Birmingham, ALUniversity of Alabama at Birmingham Women & Infants Center· Birmingham, ALUSA Health Children's and Women's Hospital· Mobile, ALUSA Health Strada Patient Care Center· Mobile, AL

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