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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Varicella seroconversion and MMR titres at 42-56 days after first vaccination

Original Primary Outcome: Same as current

Current Secondary Outcome: Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)

Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: July 17, 2006
Date Started: March 2006
Date Completion:
Last Updated: October 6, 2016
Last Verified: October 2016