NCT00627458

Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine

Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine When Given as a Booster Dose

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 403 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 16 Months – 20 Months
• Healthy volunteers: Accepted

Summary

The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).

Detailed description

This protocol posting has been updated in order to comply with the FDA AA, Sep 2007.

Conditions

• Acellular Pertussis
• Diphtheria
• Poliomyelitis
• Haemophilus Influenzae Type b
• Tetanus
• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	Infanrix Hexa	Vaccine administered as a booster dose at 16-20 months of age

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-08-18
• Completion: 2008-08-18
• First posted: 2008-03-03
• Last updated: 2018-06-06
• Results posted: 2017-06-26

Locations

6 sites across 1 country: Finland