Actively Recruiting
Phase 3 Study of a Booster Dose of Combined Diphtheria, Tetanus, and Acellular Pertussis Vaccine in Healthy Japanese Adolescents Aged 11 to Under 13 Years
Led by GlaxoSmithKline · Updated on 2026-07-28
90
Participants Needed
10
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the immune response, reactogenicity, and safety of a booster dose of the combined reduced-antigen-content diphtheria, tetanus, and acellular pertussis dTpa vaccine in healthy Japanese adolescents aged 11 to under 13 years. This phase 3, non-randomized, single-arm, open-label study aims to assess these effects one month after vaccination in this specific population. Participants aged 11 to less than 13 years receive a single booster dose of the dTpa vaccine on Day 1. The study does not include a comparison group and monitors the response to this single vaccination. The vaccine is administered once, with follow-up assessments planned after vaccination to measure immune markers and safety. Participants will be followed for up to one month after vaccination to assess immunogenicity and safety. Researchers will measure antibody responses against pertussis toxins, diphtheria, and tetanus at baseline and one month post-vaccination. Safety will be monitored through reported local and systemic adverse events up to 7 days post-vaccination and unsolicited adverse events up to 30 days. The study participation lasts approximately one month from vaccination to final safety follow-up.
CONDITIONS
Brief Title
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
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
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