RecruitingPhase 3NCT07596199

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

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


Sponsor

GlaxoSmithKline

Enrollment

95 participants

Start Date

Jun 29, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called dTpa for people with diphtheria-tetanus-acellular pertussis vaccines. The study is currently recruiting participants at 11 locations. People eligible for this study include women aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALdTpa

1 dose of dTpa vaccine is administered intramuscularly.


Locations(11)

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Fukui, Japan

GSK Investigational Site

Fukushima, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Kyoto, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Saitama, Japan

GSK Investigational Site

Saitama, Japan

GSK Investigational Site

Shizuoka, Japan

GSK Investigational Site

Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT07596199


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