drugset / Trial / NCT00443846

RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)

NCT00443846

Phase 3 Completed 247 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelPrevention

Summary

Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant administration of RotaTeq® is non-inferior to that without non-concomitant (sequential) administration of RotaTeq®.

Timeline

Start
2007-02-13
Primary completion
2007-09-04
Completion
2007-10-23

Drugs

EvaluationDrugModalityDoseRoute
Subject NeisVac-C Vaccine 0.5 ml Intramuscular
Subject Rotarix Vaccine 2 ml Oral