drugset / Trial / NCT00772928

Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™

NCT00772928

Phase 3 Completed 1167 enrolled Sanofi
RandomizedParallel-groupOpen-labelPrevention

Summary

This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™ Primary Objective - Stage I: To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®). Primary Objective - Stage II: To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.

Timeline

Start
2003-10
Primary completion
2006-05
Completion
2006-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Pentacel Vaccine 0.5 ml Intramuscular
Subject Prevnar 13 Vaccine 0.5 ml Intramuscular