NCT00263679

Assessment of GSK Biologicals' Tdap Candidate Vaccine Administered as a Booster (6th Dose) in Terms of Immunogenicity and Safety to Children and Adolescents Previously Vaccinated With Five Doses of an Acellular Pertussis-containing Vaccine.

A Phase III, Double-blinded, Randomized, Multicenter, Clinical Study to Assess the Safety and Immunogenicity of GSK Biologicals' Tdap 0.3 mg Candidate Vaccine When Given as a Booster Dose to Healthy School Children and Adolescents (9-13 Years of Age), Previously Vaccinated With a 5th Consecutive Dose of Acellular Pertussis-containing Vaccine, in Studies APV-118 or APV-120

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 9 Years – 13 Years
• Healthy volunteers: Accepted

Summary

The aims of this study are to evaluate the safety and immunogenicity of a booster dose of GSK Biological's candidate Tdap vaccine containing 0.3 mg Al when administered to healthy school children and adolescents (9-13 years of age) previously vaccinated with five consecutive doses of Pa-containing vaccine. The inclusion of hepatitis A vaccine (Havrix®) as a control vaccine enables this study to be conducted in a double-blinded in terms of immunogenicity and safety assessments.

Conditions

• Acellular Pertussis
• Diphtheria
• Tetanus

Interventions

Type	Name	Description
BIOLOGICAL	Prophylaxis: Diphtheria, tetanus and pertussis

Timeline

• Start date: 2003-11-01
• Primary completion: 2004-05-01
• Completion: 2004-10-01
• First posted: 2005-12-09
• Last updated: 2016-09-15

Locations

13 sites across 1 country: Germany