NCT00325143

Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine

Assess Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Admnd at 3 & 4 Mths & DTPa-HBV-IPV/Hib Vaccine Admnd at 5 Mths, Followed by DTPa-IPV/Hib Vaccine at 18 Mths in Infants Who Received hepatitisB Vaccine at Birth & at One Month of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 702 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 11 Weeks – 17 Weeks
• Healthy volunteers: Accepted

Summary

To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	DTPa-HBV-IPV/Hib	1 intramuscular injection (3rd study vaccine dose)
BIOLOGICAL	DTPa-IPV/Hib vaccine	3 intramuscular injections (1st, 2nd and 4th vaccine dose)

Timeline

• Start date: 2003-12-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2006-05-12
• Last updated: 2018-06-06
• Results posted: 2017-02-07

Locations

3 sites across 1 country: Singapore