NCT00158808

Immune Memory Foll Pry Vaccination With DTPw-HBV/Hib Vaccine Formulation; Immuno & Reacto of Booster Dose at 15-18 Mths

Assess the Immunogenicity &d Reactogenicity of a Booster Dose of a Formulation of GSK Biologicals' DTPw-HBV/Hib Vaccine at 15-18 Mths of Age in Infants Previously Primed With the Same Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 15 Months
• Healthy volunteers: Accepted

Summary

To assess the anti-PRP antibody response one month after vaccination in the groups receiving a fourth consecutive dose of two formulations of DTPw-HBV/Hib vaccine

Detailed description

All subjects were previously primed with one of the two formulations of the combined DTPw-HBV/Hib vaccine. At the age of 10 months, 50% of each group received a plain PRP challenge to assess the immune memory to PRP. In this booster study in the second year of life, all subjects who received DTPw-HBV/Hib and plain PRP will receive DTPw-HBV as a booster vaccination. All other subjects will receive as booster the same vaccine they received in the primary vaccination study.

Conditions

• Hib Disease
• Hepatitis B
• Pertussis
• Prophylaxis of Diphtheria
• Tetanus

Interventions

Type	Name	Description
BIOLOGICAL	Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib

Timeline

• Start date: 2005-01-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2005-09-12
• Last updated: 2017-05-30

Locations

1 site across 1 country: Philippines