NCT00197275

Lot-to-lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Infants

Demonstrate Lot-to-lot Consistency of Final Production Method of GSK Biologicals' Hib-MenAC Vaccine Mixed Extemporaneously With Tritanrix™-HepB & Demonstrate Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Healthy Infants at 2, 4 and 6 Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 56 Days – 83 Days
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and meningococcal serogroups A and C) vaccine when reconstituted with Tritanrix™-HepB (diphtheria, tetanus, pertussis, and hepatitis B) vaccine and administered as a single injection.

Detailed description

The study is double blind. However the active control vaccine Tritanrix™-HepB/Hiberix™ will be administered in a single-blind manner. Blood samples will be collected for immunogenicity analyses. GSK Biologicals' OPV vaccine will be administered concomitantly with the study vaccines at 2, 4 and 6 months of age according to local country regulation. The study will last approximately 5 months per subject

Conditions

• Tetanus
• Hepatitis B
• Haemophilus Influenzae Type b
• Whole Cell Pertussis
• Diphtheria

Interventions

Type	Name	Description
BIOLOGICAL	Hib-MenAC mixed with Tritanrix™-HepB

Timeline

• Start date: 2006-02-01
• Completion: 2006-11-01
• First posted: 2005-09-20
• Last updated: 2016-10-07

Locations

3 sites across 1 country: Thailand