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