drugset / Trial / NCT00617760

Safety and Immunogenicity Study of MenC-TT Vaccine (NeisVac-C) in Toddlers Previously Immunized With PCV7 (Prevenar®)

NCT00617760

Phase 3 Completed 330 enrolled Pfizer
RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study in healthy toddlers who have not previously been immunized against MenC infection and who completed their primary immunization series with PCV-7 (3 vaccinations) during infancy is to demonstrate that the concomitant administration of a single dose of MenC-TT vaccine and a PCV7 booster does not influence the immune response to the seven pneumococcal strains contained in PCV7 as compared to administration of PCV7 alone, and does not influence the immune response to the MenC-TT vaccine as compared to administration of MenC-TT vaccine alone.

Timeline

Start
2008-03
Primary completion
2009-08
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator MenC-TT Vaccine 0.5 ml Intramuscular
Comparator Prevnar 13 Vaccine 0.5 ml Intramuscular