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.
Pfizer
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.
Description
This study will include pregnant participants and their unborn babies (Cohort 1 and Cohort 2) and non-pregnant participants (Cohort 3), as described below: * 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 placeb…
Eligibility
- Age range
- 0+ years
- Sex
- All
- Healthy volunteers
- Yes
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.…
Interventions
- BiologicalRSVpreF
Single Dose
- BiologicalPlacebo
Single Dose
Locations (94)
- Center for Research in Women's HealthBirmingham, Alabama
- Children's of AlabamaBirmingham, Alabama
- University of Alabama at Birmingham - School of MedicineBirmingham, Alabama
- University of Alabama at Birmingham Women & Infants CenterBirmingham, Alabama
- USA Health Children's and Women's HospitalMobile, Alabama
- USA Health Strada Patient Care CenterMobile, Alabama