Clinical Trial: MMR and MMRV Vaccines: Effect of Age at First Dose on Safety and Immunogenicity of the Measles Component.

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Measles-mumps-rubella and Measles-mumps-rubella-varicella Vaccines: Effect of Age at First Dose on Safety and Immunogenicity of the

Brief 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.


Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Québec, CHU de Québec

Current Primary Outcome: 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 ]

Antibody titers are expressed as Geometric Mean Concentrations (GMC) in mIU/mL. The cut-off for seropositivity is anti-measles antibody titer ≥ 150 mIU/mL (performed on seronegative subjects prior to vaccination).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Injection site reaction [ Time Frame: Days 0-3 after vaccination ]
    Injection site reaction is defined by the presence of pain, redness and swelling
  • Systemic symptoms [ Time Frame: Days 0 - 42 after administration of a dose of MMR or MMRV vaccine ]
    Will include fever (defined as rectal temperature ≥38°C), general malaise and measles-like rash
  • 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 ]
    Antibody titers are expressed as Geometric Mean Concentrations (GMC) in mIU/mL The cut-off for seropositivity is anti-measles antibody titer ≥ 150 mIU/mL


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Québec, CHU de Québec

Dates:
Date Received: March 14, 2016
Date Started: July 2004
Date Completion: December 2016
Last Updated: March 14, 2016
Last Verified: March 2016