NCT01457495

Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly

Study to Assess Immunogenicity and Reactogenicity of SB Biologicals' DTPa-HBV-IPV/Hib Vaccine Given as Three-dose Primary Vaccination Course Compared to DTPa-IPV/Hib and HBV Administered Concomitantly at Separate Sites

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Weeks – 16 Weeks
• Healthy volunteers: Accepted

Summary

This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age.

Conditions

• Hepatitis B
• Diphtheria
• Haemophilus Influenzae Type b (Hib)
• Poliomyelitis
• Pertussis
• Tetanus

Interventions

Type	Name	Description
BIOLOGICAL	DTPa-HBV-IPV/Hib (Infanrix-hexa™)	3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8
BIOLOGICAL	DTPa-IPV/Hib (Infanrix-IPV/Hib™)	3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8
BIOLOGICAL	HBV (Engerix™-B)	3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8

Timeline

• Start date: 1998-09-01
• Primary completion: 1999-09-01
• Completion: 1999-09-01
• First posted: 2011-10-24
• Last updated: 2017-06-16