drugset / Trial / NCT00891176

Persistence of Antibodies at 3, 4 and 6 Years of Age After Vaccination With Meningococcal, Pneumococcal and Hib Vaccines

NCT00891176

Phase 3 Completed 582 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

Summary

This protocol posting deals with objectives \& outcome measures of an extension phase when subjects are aged 3, 4 and 6 years of age. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00334334). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT number = NCT00463437). The purpose of this study is to evaluate the persistence of pneumococcal, meningococcal serogroup C, Hib and Hepatits B antibodies after booster vaccination, when the subjects are aged 3, 4 and 6 years. No vaccine will be administered during this persistence phase of the study.

Timeline

Start
2009-05-14
Primary completion
2012-11-21
Completion
2012-11-21

Drugs

EvaluationDrugModalityDoseRoute
Subject InfanrixTM IPV/Hib Unknown Intramuscular
Subject InfanrixTM hexa Vaccine Intramuscular
Subject MeningitecTM Unknown Intramuscular
Subject MenitorixTM Unknown Intramuscular
Subject NeisVac-CTM Unknown Intramuscular
Comparator PrevenarTM Unknown Intramuscular
Subject Synflorix Vaccine Intramuscular
Background InfanrixTM IPV Unknown Intramuscular
Background InfanrixTM penta Unknown Intramuscular