Phase 3 Study to Evaluate Safety and Immune Response of a Single Dose dTpa Vaccine in Healthy Japanese Pregnant Women Between 27 and 36 Weeks of Pregnancy

What this Trial Is About

Researchers are evaluating the immune response, safety, and side effects of a combined vaccine against diphtheria, tetanus, and acellular pertussis dTpa in healthy Japanese pregnant women between 27 weeks and less than 37 weeks of pregnancy. This Phase 3, non-randomized, single-arm, open-label study also assesses the immune response in newborns born during the study. Healthy pregnant women between 27 and 36 weeks of gestation will receive one dose of the dTpa vaccine administered intramuscularly on Day 1. The study will monitor both the women and their newborns for immune response and safety outcomes over time, including antibody levels and any adverse events up to one month post-delivery. Participants will provide blood samples at vaccination, one month later, and cord blood samples at birth to measure antibody responses. Researchers will track pregnancy outcomes, side effects in mothers and newborns, and follow participants until one month after delivery. The main outcome measurements include antibody levels against pertussis, diphtheria, and tetanus, as well as monitoring for any adverse events during and after vaccination.

A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women