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

Hepatitis B Clinical Trial

Official title:
Assess Reactogenicity and Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Compared to Tritanrix™-HepB/Hiberix™ (Control) in Healthy Infants (2,4,6 Months Age), After a Hepatitis B Birth Dose

Clinical Trial 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™.

Clinical Trial 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™ ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00317135
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date December 11, 2003
Completion date October 23, 2004
View Details
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