NCT00879827

Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants

Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV and Hib Vaccines When Administered Concomitantly to Healthy Infants Administered as a Three-dose Primary Vaccination Course at the Age of 1.5, 3.5 and 6 Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 8 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.

Conditions

• Diphtheria
• Poliomyelitis
• Hepatitis B
• Tetanus
• Acellular Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	Pediarix TM, Infanrix penta TM	The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
BIOLOGICAL	Hiberix TM	The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.

Timeline

• Start date: 2000-09-01
• Primary completion: 2001-05-01
• Completion: 2001-05-01
• First posted: 2009-04-13
• Last updated: 2016-09-07