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.
Study Type
OBSERVATIONAL
Enrollment
5,808
Subcutaneous injection, two doses
Short term seropositivity rates & anti-measles antibody titers after vaccination with MMR or MMRV
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).
Time frame: At day 42 after administration of a dose of MMR or MMRV vaccine
Injection site reaction
Injection site reaction is defined by the presence of pain, redness and swelling
Time frame: Days 0-3 after vaccination
Systemic symptoms
Will include fever (defined as rectal temperature ≥38°C), general malaise and measles-like rash
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
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
Time frame: 2 and 3 years after vaccination with 2 doses of MMR or MMRV vaccines
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