NCT00197236

Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months

Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With GSK Biologicals' DTaP Vaccine (Infanrix™) and Aventis Pasteur's Haemophilus b Conjugate Vaccine (ActHIB) in Healthy Children 15 Months of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 468 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 13 Months
• Healthy volunteers: Accepted

Summary

This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15 months of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

An open, controlled comparison of Havrix™ administered alone or with Infanrix™ and ActHIB. The three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + Infanrix™ and ActHIB and 3) Infanrix™ and ActHIB followed by Havrix™ one month later.

Conditions

• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	Havrix™	2 intramuscular injections, 6 months apart
BIOLOGICAL	Infanrix™	1 intramuscular injection
BIOLOGICAL	ActHIB™	1 intramuscular injection

Timeline

• Start date: 2003-11-11
• Primary completion: 2007-12-03
• Completion: 2007-12-03
• First posted: 2005-09-20
• Last updated: 2018-08-20
• Results posted: 2009-07-24

Locations

22 sites across 1 country: United States