NCT00332566

Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib

Immunogenicity, Reactogenicity & Safety of a Booster Dose of GSK Biologicals' DTPw-HBV/Hib Kft Vaccine Vs GSK Biologicals' DTPw-HBV/Hib Vaccine, in Infants Who Received a 3-Dose Primary Vaccination Course With the Same Vaccines.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Months – 24 Months
• Healthy volunteers: Accepted

Summary

This booster study will assess the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy children, 18 to 24 months of age, who received the same vaccine for primary vaccination. Prior to the booster dose, this study will also assess the persistence of antibodies to the vaccine antigen components administered in the primary vaccination course. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

• Hepatitis B
• Whole Cell Pertussis
• Tetanus
• Haemophilus Influenzae Type b
• Diphtheria

Interventions

Type	Name	Description
BIOLOGICAL	DTPw-HBV/Hib Kft vaccine GSK323527A	Intramuscular injection, 1 dose
BIOLOGICAL	Tritanrix™-HepB/Hiberix™	Intramuscular injection, 1 dose

Timeline

• Start date: 2006-06-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2006-06-01
• Last updated: 2016-09-28

Locations

2 sites across 2 countries: Argentina, Nicaragua