A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine

This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of age).

Completed

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Key information

Conditions

Diphtheria Acellular Pertussis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Clostridium Infections Corynebacterium Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infections Respiratory Tract Diseases Respiratory Tract Infections Tetanus Whooping Cough

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Mesa, Arizona, United States

About this study

A combined Tdap (Tetanus, Diphteria, Acellular Pertussis) Vaccine Used as a Booster compared to Licensed Td (Tetanus and Diphteria) vaccine

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy adolescents with history of completed routine vaccination against diphtheria, tetanus, and pertussis (DTP).

Exclusion criteria

Use of any other investigational drug or vaccine 30 days preceding study vaccination.
Chronic administration of immunosuppressants.
Administration of pre-school DTP vaccine within previous 5 years.
Administration of Td booster within previous 10 years.

Treatment and study plan

Combined diphtheria, tetanus, acellular pertussis vaccine

Biological

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase III, Observer-blinded Randomised, Multi-centre Clinical Study of the Safety, Immunogenicity and Consistency of Three Manufacturing Lots of GSK Biologicals' Candidate Tdap Vaccine as Compared to a US-licensed Td Vaccine When Given as a Booster Dose to Healthy Adolescents (10-18 Years of Age)

Important dates

Study start: 2002
Primary completion: 2004
Study completion: 2004
First posted: Apr 27, 2005
Registry last updated: Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed