NCT00317187

Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.

Partially Blinded Study to Assess Reactogenicity & Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ in Healthy Infants After a Hepatitis B Birth Dose

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 56 Days – 83 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the reactogenicity \& safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.

Detailed description

Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth: * One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups) * GSK Biologicals' Tritanrix™-HepB/Hiberix™

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Tritanrix-HepB/Meningitec conjugate vaccine	The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection
BIOLOGICAL	Tritanrix/Hiberix vaccine	The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection.

Timeline

• Start date: 2004-06-08
• Primary completion: 2005-01-16
• Completion: 2005-01-16
• First posted: 2006-04-24
• Last updated: 2018-08-15

Locations

1 site across 1 country: Thailand