drugset / Trial / NCT00317135

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

NCT00317135

Phase 3 Completed 500 enrolled GlaxoSmithKline
RandomizedParallel-groupPrevention

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™.

Timeline

Start
2003-12-11
Primary completion
2004-10-23
Completion
2004-10-23

Drugs

EvaluationDrugModalityDoseRoute
Comparator HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN Vaccine Intramuscular
Subject Meningitec Vaccine Intramuscular
Comparator Tritanrix-HepB Vaccine Intramuscular