Measles-mumps-rubella and Measles-mumps-rubella-varicella Vaccines: Effect of Age at First Dose on Safety and Immunogenicity of the Measles Component.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5,808
- 主要终点
- Short term seropositivity rates & anti-measles antibody titers after vaccination with MMR or MMRV
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 11 Months 至 22 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Short term seropositivity rates & anti-measles antibody titers after vaccination with MMR or MMRV
时间窗: 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).
次要结局
- Injection site reaction(Days 0-3 after vaccination)
- 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)
- Systemic symptoms(Days 0 - 42 after administration of a dose of MMR or MMRV vaccine)
研究者
Gaston De Serres
MD, PhD
CHU de Quebec-Universite Laval