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

Recruiting Phase 3 Interventional Study
Diphtheria-Tetanus-acellular Pertussis Vaccines
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
11 – 12
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
90 (estimated)
Sponsor
GlaxoSmithKline · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participants and/or participants' parent(s)/ Legally acceptable representative(s) \[LAR(s)\], who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Physical or digital informed assent obtained from the participant prior to perfor…
Contacts

US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

CONTACT

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

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