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drugset / Trial / NCT00475033

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

NCT00475033 ↗

Phase 3 Completed 603 enrolled Wyeth is now a wholly owned subsidiary of Pfizer
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccinations in Canada. Immune responses induced by the infant series (NeisVac-C® and Pentacel®)and toddler dose(NeisVac-C®)of routine pediatric vaccines when administered with 13-valent pneumococcal conjugate vaccine will be studied for noninferiority to the immune responses when administered with 7-valent pneumococcal conjugate vaccine. Safety profile and immunogenicity of 13-valent pneumococcal conjugate vaccine will also be evaluated.

Timeline

Start
2007-06
Primary completion
2009-05
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Prevnar 13 Vaccine — —

Indications

No indication recorded.