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.
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…
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