Clinical Trial

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

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this Phase 3, non-randomized, single-arm, open-label study is to evaluate the immune response, reactogenicity and safety of GSKs dTpa vaccine in Japanese pregnant women between 27 weeks and less than 37 weeks of pregnancy. Both the pregnant women and their neonates born during the study will be evaluated for specific analyses.
Protocol Amendment History 3 changes
notable Trial sites expanded: 11 -> 18 locations 2026-07-29
critical Recruitment opened 2026-07-09
notable Trial sites expanded: 0 -> 11 locations 2026-07-09
Trial Details
NCT Number NCT07596199
Lead Sponsor GlaxoSmithKline
Conditions Diphtheria-Tetanus-acellular Pertussis Vaccines
Enrollment 100 participants
Start Date 2026-06-29
Primary Completion 2026-12-11 (estimated)
Study Completion 2027-01-20 (estimated)
Updated on ClinicalTrials.gov 2026-07-28