NCT00353288

Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™

Comparative Study Evaluating the Immunogenicity and Safety of MeMuRu-OKA Vaccine and Measles-mumps-rubella Vaccine (Priorix™) Co-administered With Varicella Vaccine (Varilrix™) in Children Primed With Measles-mumps-rubella Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 446 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 15 Months – 6 Years
• Healthy volunteers: Accepted

Summary

As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.

Conditions

• Varicella
• Rubella
• Measles
• Mumps

Interventions

Type	Name	Description
BIOLOGICAL	MeMuRu-OKA (study vacc)
BIOLOGICAL	MMR, Varicella vacc (control)

Timeline

• Start date: 2006-03-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2006-07-18
• Last updated: 2016-10-07

Locations

39 sites across 3 countries: France, Germany, Italy