NCT00376779

Immunogenicity and Safety of a DTPa-HBV-IPV/Hib Vaccine Given at 2, 3 and 4 Months of Age

A Phase II, Observer-blind, Randomized Study to Evaluate the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Combined DssiTgdPa-HBV-IPV/Hib Vaccine Containing Diphtheria Toxoid From the Statens Serum Institute (SSI) of Denmark and Tetanus Toxoid From GSK Biologicals' Kft [GD], Compared to the Currently Licensed GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (Infanrix Hexa TM) When Administered to Healthy Infants at 2, 3 and 4 Months of Age.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 8 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this study is to show that the immunogenicity of newly formulated DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed formulation of the vaccine. The vaccine will be administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age and its safety and reactogenicity will also be assessed.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Infanrix hexa Vaccine

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2006-09-15
• Last updated: 2016-11-04

Locations

6 sites across 1 country: Finland