Study to Assess Safety & Immunogenicity of GSK Biologicals' Boostrix (dTpa) Vaccine vs. Chinese DT Vaccine

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Diphtheria

Tetanus

Acellular Pertussis

Treatments

Biological: Boostrix

Biological: Chinese DT vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00452686

108638

Details and patient eligibility

About

This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals' reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in comparison with Chinese DT vaccine, in children 6-8 years of age.

Sex

All

Ages

6 to 8 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

A male or female between, and including, 6-8 years of age at the time of vaccination,
Written informed consent obtained from the parent or guardian of the subject,

Exclusion criteria

Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate.
Subjects with history of diphtheria, pertussis or tetanus diseases can not participate.