Overview

This trial is active, not recruiting.

Condition measles
Treatment mmr vaccine / mmrv vaccine
Sponsor Centre Hospitalier Universitaire de Québec, CHU de Québec
Collaborator GlaxoSmithKline
Start date July 2004
End date July 2010
Trial size 5808 participants
Trial identifier NCT02712203, 200783

Summary

Healthy children who received two doses of GlaxoSmithKline (GSK) Biologicals' live attenuated measles-mumps-rubella vaccine (MMR) or measles-mumps-rubella-varicella vaccine (MMRV) in their second year of life.The purpose of this study is to assess the effect of the age at administration of the first dose on the reactogenicity and immunogenicity of the measles component of these vaccines.

In addition, this study will evaluate if the effect of the age at first dose is modified by the type of vaccine administered.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age
mmr vaccine / mmrv vaccine Priorix®
Subcutaneous injection, two doses
MMR vaccine / MMRV vaccine : administration of the first dose at 13 months of age
mmr vaccine / mmrv vaccine Priorix®
Subcutaneous injection, two doses
MMR vaccine / MMRV vaccine : administration of the first dose at 14 months of age
mmr vaccine / mmrv vaccine Priorix®
Subcutaneous injection, two doses
MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age or older
mmr vaccine / mmrv vaccine Priorix®
Subcutaneous injection, two doses

Primary Outcomes

Measure
Short term seropositivity rates & anti-measles antibody titers after vaccination with MMR or MMRV
time frame: At day 42 after administration of a dose of MMR or MMRV vaccine

Secondary Outcomes

Measure
Injection site reaction
time frame: Days 0-3 after vaccination
Systemic symptoms
time frame: Days 0 - 42 after administration of a dose of MMR or MMRV vaccine
Long term seropositivity rates and anti-measles antibody titers after vaccination with MMR or MMRV
time frame: 2 and 3 years after vaccination with 2 doses of MMR or MMRV vaccines

Eligibility Criteria

Male or female participants from 11 months up to 22 months old.

Inclusion Criteria: - Healthy male or female subject between 11 to 22 months at the time of first vaccination. - Written informed consent obtained from the parent/guardian of the subject. Exclusion Criteria: - History of previous measles, mumps, rubella and/or varicella vaccination or disease or known exposure to any of these diseases within 30 days prior to the inclusion in the study. - Any confirmed or suspected immunosuppressive or immunodeficient condition, included the chronic administration (defined as more than 14 days) of immune-suppressants or other immune-modifying drugs within six months prior to the firs vaccine dose. - History of any neurologic disorders or seizures. - History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines. - Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination

Additional Information

Official title Measles-mumps-rubella and Measles-mumps-rubella-varicella Vaccines: Effect of Age at First Dose on Safety and Immunogenicity of the Measles Component.
Principal investigator Gaston De Serres, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Québec, CHU de Québec.