drugset / Trial / NCT07596199
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Non-randomizedSingle-groupOpen-labelPrevention
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.
Timeline
- Start
- 2026-06-29
- Primary completion
- 2026-12-11
- Completion
- 2027-01-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DTPa | Vaccine | — | Intramuscular |
Indications
No indication recorded.