NCT00320463

Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants

Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 415 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 11 Weeks – 17 Weeks
• Healthy volunteers: Accepted

Summary

In this study, infants will be randomly allocated into three groups: * one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation) * the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation) * the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.

Detailed description

A study to compare the immunogenicity \& safety of 2 formulations of GlaxoSmithKline (GSK) Biologicals' DTPa-HBV-IPV/Hib vaccine given in healthy infants at 3,4 \& 5 months age. The immunogenicity \& safety of DTPa-HBV-IPV vaccine will also be evaluated in a 3rd group of subjects Subjects in the group that will receive DTPa-HBV-IPV/Hib vaccine (current formulation) will be the control group for the group that will receive DTPa-HBV-IPV/Hib vaccine (new formulation)

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	DTPa-HBV-IPV/Hib vaccine

Timeline

• Start date: 2006-04-01
• Completion: 2007-01-01
• First posted: 2006-05-03
• Last updated: 2016-10-12

Locations

4 sites across 1 country: Russia