Recruiting

Phase 3

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

Sponsor:

Pfizer

Code:

NCT06866405

Conditions

RSV Infection

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

RSVpreF

Placebo

Study Details

Brief 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.

Conditions

RSV Infection

Study ID

NCT06866405

Start date

Apr 16, 2025

Status verified date

Aug, 2026

Completion date

Feb 24, 2028

Anticipated

Primary completion date

Feb 24, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: RSVpreF

placebo comparator: Placebo

Interventions

RSVpreF

Single Dose

Placebo

Single Dose

Primary outcome measure

Percentage of pregnant participants reporting local reactions [ Time Frame: From Day 1 Through at least Day 7 after Vaccination ]
Percentage of pregnant participants reporting systemic events [ Time Frame: From Day 1 Through at least Day 7 after Vaccination ]
Percentage of pregnant participants reporting adverse events [ Time Frame: From Day 1 through 4 weeks after vaccination ]
Percentage of pregnant participants reporting serious adverse events [ Time Frame: From Day 1 throughout the study ]
In infant participants born to pregnant participants receiving a second dose of the study intervention, the percentage of participants reporting adverse events. [ Time Frame: From birth through 1 month of age ]
In infant participants born to pregnant participants receiving a second dose of the study intervention, the percentage of participants reporting serious adverse events and newly diagnosed medical conditions. [ Time Frame: From birth through 6 months of age. ]
Proportion of participants achieving neutralizing antibody to RSV A and RSV B at birth [ Time Frame: At birth ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Center for Research in Women's Health

Recruiting

Birmingham, Alabama, United States, 35233

Children's of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

University of Alabama at Birmingham - School of Medicine

Recruiting

Birmingham, Alabama, United States, 35233

University of Alabama at Birmingham Women & Infants Center

Recruiting

Birmingham, Alabama, United States, 35233

USA Health Children's and Women's Hospital

Recruiting

Mobile, Alabama, United States, 36604

USA Health Strada Patient Care Center

Recruiting

Mobile, Alabama, United States, 36604

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90024

Ronald Reagan UCLA Medical Center (inpatient hospital)

Recruiting

Los Angeles, California, United States, 90095

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

UCLA (outpatient clinic)

Recruiting

Los Angeles, California, United States, 90095

UCLA Clinical and Translational Research Center (research clinic)

Recruiting

Los Angeles, California, United States, 90095

UCLA

Recruiting

Los Angeles, California, United States, 90095

Lucile Packard Children's Hospital-Labor and Delivery Unit

Recruiting

Palo Alto, California, United States, 94304

Stanford Obstetrics Clinic

Recruiting

Palo Alto, California, United States, 94304

Stanford University Medical Center

Recruiting

Palo Alto, California, United States, 94304

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Anschutz Health Sciences Building (AHSB)

Recruiting