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RECRUITING
NCT07596173
PHASE3

A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Healthy Japanese Adolescents Aged 11 Years to <13 Years

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of the study is to assess the immune response, reactogenicity and safety of a booster dose of dTpa vaccine 1 month after vaccination in healthy Japanese participants aged 11 to \<13 years.

Official title: A Phase 3, Non-randomized, Single-arm, Open-label Study to Assess the Immunogenicity, Safety and Reactogenicity of Combined Reduced-antigen-content Diphtheria, Tetanus and Acellular Pertussis (dTpa) Vaccine, Administered as a Booster Dose in Healthy Japanese Adolescents Aged 11 Years to <13 Years

Key Details

Gender

All

Age Range

11 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-06-29

Completion Date

2026-10-14

Last Updated

2026-07-28

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

dTpa vaccine

Combined reduced antigen content diphtheria, tetanus and acellular pertussis (dTpa) vaccine administered at Day 1.

Locations (10)

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Kumamoto, Japan

GSK Investigational Site

Mie, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Saitama, Japan

GSK Investigational Site

Saitama, Japan

GSK Investigational Site

Shizuoka, Japan