Measles
Conditions
Keywords
Measles vaccine, Priorix, Priorix-Tetra, Age at vaccination
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.
Interventions
BIOLOGICALMMR vaccine / MMRV vaccine
Subcutaneous injection, two doses
Sponsors
GlaxoSmithKline
CHU de Quebec-Universite Laval
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
11 Months to 22 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short term seropositivity rates & anti-measles antibody titers after vaccination with MMR or MMRV | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Injection site reaction | Days 0-3 after vaccination | Injection site reaction is defined by the presence of pain, redness and swelling |
| Systemic symptoms | 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 | 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 |
Outcome results
None listed