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NOT YET RECRUITING
NCT07596199
PHASE3

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

Sponsor: GlaxoSmithKline

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.

Official title: A Phase 3, Non-Randomized, Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety and Reactogenicity of a Single Dose of Combined Reduced-Antigen-Content Diphtheria, Tetanus and Acellular Pertussis (dTpa) Vaccine in Japanese Healthy Pregnant Women

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

95

Start Date

2026-06-29

Completion Date

2027-01-20

Last Updated

2026-05-19

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

dTpa

1 dose of dTpa vaccine is administered intramuscularly.