NCT00109278已完成2 期
A Comparison of the Safety, Tolerability, and Immunogenicity of V205C Manufactured From the 2003 Measles Stock Seed With Recombinant Human Albumin (rHA) Versus Currently Licensed V205C Manufactured From the 1967 Measles Stock Seed With Human Serum Albumin (HSA) in Healthy Children 12 to 18 Months of Age
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,100
- 主要终点
- Antibody response rate to measles at 6 weeks postvaccination
研究概览
简要总结
The purpose of this study is to test the safety of a measles, mumps, and rubella study vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA (recombinant human albumin).
详细描述
The duration of treatment is 6 weeks.
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
- Double (Participant, Investigator)
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
- •Healthy children 12 to 18 months of age.
排除标准
- •Previous receipt of measles, mumps, rubella and/or varicella vaccine.
- •Prior infection or exposure to (within last 4 weeks) measles, mumps, rubella, varicella and/or zoster.
- •Any medical condition that might interfere with the immune response to the given vaccines (including HIV infection and/or cancer) or has undergone immunosuppressive (weakens your body's ability to fight infection) therapy.
- •History of seizures (convulsions)
- •Allergies to any component of the vaccine, including sorbitol, gelatin, or neomycin.
- •A recent (within the last 3 days) illness resulting in a fever (underarm temperature greater than 99.5° F [37.5° C]).
结局指标
主要结局
Antibody response rate to measles at 6 weeks postvaccination
次要结局
- Geometric mean titers to measles by ELISA at 6 weeks postvaccination
研究者
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