drugset / Trial / NCT00839917

A Study of ProQuad™ in Healthy Children in Korea (V221-023)

NCT00839917

Phase 3 Terminated 30 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelPrevention

Summary

This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be non-inferior to the antibody response rates after vaccination with concomitant M-M-R™ II and Varivax™.

Timeline

Start
2008-02
Primary completion
2008-05
Completion
2008-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator M-M-R II Vaccine 0.5 ml Subcutaneous
Subject ProQuad Vaccine 0.5 ml Subcutaneous
Comparator Varivax Vaccine 0.5 ml Subcutaneous