drugset / Trial / NCT00129116

3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age

NCT00129116

Phase 2 Completed 388 enrolled GlaxoSmithKline
RandomizedParallel-groupTriple-blindPrevention

Summary

This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.

Timeline

Start
2003-03-01
Primary completion
2003-12-01
Completion
2003-12-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Hib-MenC-TT vaccine Vaccine Intramuscular
Subject Hib-MenCY-TT vaccine Vaccine Intramuscular
Comparator Menjugate Vaccine Intramuscular
Comparator Infanrix hexa Vaccine Intramuscular
Background Pediarix Vaccine Intramuscular