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

Study Overview
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Brief Summary
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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.

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

Conditions
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Measles

Intervention / Treatment
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* Biological: MMR vaccine / MMRV vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Months
Maximum Age: 22 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 12 months<br>MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age | Biological: MMR vaccine / MMRV vaccine<br>* Subcutaneous injection, two doses<br>* Other names: Priorix-Tetra®;|
| 13 months<br>MMR vaccine / MMRV vaccine : administration of the first dose at 13 months of age | Biological: MMR vaccine / MMRV vaccine<br>* Subcutaneous injection, two doses<br>* Other names: Priorix-Tetra®;|
| 14 months<br>MMR vaccine / MMRV vaccine : administration of the first dose at 14 months of age | Biological: MMR vaccine / MMRV vaccine<br>* Subcutaneous injection, two doses<br>* Other names: Priorix-Tetra®;|
| 15 months or more<br>MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age or older | Biological: MMR vaccine / MMRV vaccine<br>* Subcutaneous injection, two doses<br>* Other names: Priorix-Tetra®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | At day 42 after administration of a dose of MMR or MMRV vaccine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection site reaction | Injection site reaction is defined by the presence of pain, redness and swelling | Days 0-3 after vaccination | 
| Systemic symptoms | Will include fever (defined as rectal temperature ≥38°C), general malaise and measles-like rash | 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 | 2 and 3 years after vaccination with 2 doses of MMR or MMRV vaccines | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Measles vaccine, Priorix, Priorix-Tetra, Age at vaccination