drugset / Trial / NCT00127855

Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine

NCT00127855

Phase 2 Completed 409 enrolled GlaxoSmithKline
RandomizedParallel-groupTriple-blindPrevention

Summary

This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody persistence and immune responses to polysaccharide vaccine boosters were additionally assessed at 11 to 14 months of age.

Timeline

Start
2003-03-01
Primary completion
2004-02-01
Completion
2004-02-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator ActHIB Vaccine Intramuscular
Subject Hib-MenCY-TT vaccine Vaccine Intramuscular
Subject Mencevax™ ACWY Vaccine Intramuscular
Comparator Meningitec Vaccine Intramuscular
Subject PRP (Polyribosyl Ribitol Phosphate) Unknown 10 ug Intramuscular
Background Pediarix Vaccine Intramuscular
Background Prevnar 13 Vaccine Intramuscular