Pilot Trial Comparing Safety and Effectiveness of Giving Tdap and RSV Vaccines Together or Separately During Pregnancy

What this Trial Is About

This trial studies pregnant individuals to find out if giving the RSV vaccine and Tdap vaccine together during the same visit or separately at different visits is more effective and safe. It aims to test the feasibility of running such a randomized trial and to learn about immune responses and safety during pregnancy. The study is a phase 4 prevention trial focusing on healthy pregnant women aged 18 to 49 weeks of gestation 28 to 296. Participants are randomly placed in one of two groups one where they receive both vaccines at the same visit, and another where the vaccines are given at separate visits. The vaccines used are the RSVpreF vaccine and the Tdap vaccine, administered according to product guidelines with placebo controls to maintain blinding. There are 4 main study visits involving blood collection and vaccinations, plus 6 optional visits to collect breast milk and infant blood samples for antibody testing. During the study, participants will have blood drawn from themselves and their infants, breast milk collected, and will keep a symptom diary. The research team will measure vaccine safety, immune responses including antibody levels in blood and breast milk, and monitor adherence to study procedures. The total study duration covers from enrollment through about 12 weeks for the main study, with additional follow-ups if participating in exploratory parts.

Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy