Study to Assess the Safety & Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Given at 6-8 Years of Age.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diphtheria; Tetanus; Acellular Pertussis

Treatments: Biological: Boostrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00406562

107924

Details and patient eligibility

About

This study will evaluate the safety and reactogenicity of booster dose of GSK Biologicals' dTpa vaccine (Boostrix) in Chinese children at 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,
• Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life,

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)