NCT00406211已完成3 期
Follow-up to Evaluate the the Immunogenicity & Safety of GSK Biologicals' MMRV Vaccine Given as a Two-dose Schedule in the Second Year of Life, as Compared to Separate Administration of GSK Biologicals' Priorix® & Varilrix®.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 398
- 试验地点
- 42
- 主要终点
- Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year
研究概览
简要总结
Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany & Austria. Blood samples were collected at three time points during the follow-up period (Year 1, 2 & 3). No new subjects will be enrolled in these follow-up phases of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent from the parents/guardians of the child before participating in the long-term follow-up.
- •Subjects must have received their complete vaccination course according to the group allocation (i.e. subjects must have received either two doses of MMRV combined vaccine, or two doses of Priorix vaccine and one dose of Varilrix vaccine as separate injections in the primary vaccination study.
- •Subjects were aged between 12 to 18 months of age at the time of the first vaccination in the primary study.
排除标准
- •Subjects must not have received an additional dose of measles, mumps, rubella or varicella containing vaccines.
结局指标
主要结局
Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year
Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination
次要结局
未报告次要终点
研究者
研究点 (42)
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