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

• Conditions: Measles
• Interventions: Biological: MMR vaccine / MMRV vaccine

• Registration Number: NCT02712203
• Lead Sponsor: CHU de Quebec-Universite Laval

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 Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2010-07
• Status Verified: 2016-03
• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-14
• Last Update Submitted: 2016-03-14
• Study First Posted: 2016-03-18
• Last Update Posted: 2016-03-18
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5808

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
14 months	MMR vaccine / MMRV vaccine	MMR vaccine / MMRV vaccine : administration of the first dose at 14 months of age
15 months or more	MMR vaccine / MMRV vaccine	MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age or older
12 months	MMR vaccine / MMRV vaccine	MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age
13 months	MMR vaccine / MMRV vaccine	MMR vaccine / MMRV vaccine : administration of the first dose at 13 months of age

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Injection site reaction	Days 0-3 after vaccination	Injection site reaction is defined by the presence of pain, redness and swelling
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
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