NCT00388440已完成4 期
Phase IV Open Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Live Attenuated Measles-Mumps-Rubella (MMR) Vaccine When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Solicited symptoms (Day 0-3); unsolicited AEs (Day 0-42); SAEs (full study)
研究概览
简要总结
To evaluate the safety and immunogenicity of GSK Biologicals' live attenuated MMR vaccine (Priorix) in a local population in Singapore. The vaccine was administered as a single dose to healthy children (12-18 months of age) and blood samples were collected at two time points (before vaccination and after vaccination).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •A male or female infant between 12 and 18 months of age at the time of the vaccination
- •Written informed consent obtained from the parents or guardians of the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
排除标准
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the dose of study vaccine
- •Previous vaccination against mumps and/or rubella
- •History of, or intercurrent, measles, mumps, and/or rubella disease
- •Known exposure to measles, mumps or rubella within 30 days prior to the start of the study
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
结局指标
主要结局
Solicited symptoms (Day 0-3); unsolicited AEs (Day 0-42); SAEs (full study)
次要结局
- Antibody concentration to all vaccine antigens after vaccination
研究者
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