A Study of M-M-R(TM) II at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,997
- 主要终点
- Neutralizing antibodies to mumps at 6 weeks postvaccination
研究概览
简要总结
The purpose of this study is to determine the mumps virus strength at the end of shelf-life (expiration date) of an approved vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •History or prior exposure to measles, mumps, rubella or varicella
- •History of anaphylactoid reactions or hypersensitivity to any component of the vaccine, including gelatin and neomycin
研究组 & 干预措施
Control Group
M-M-R(TM) II at current release potency
干预措施: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck) (Biological)
Mumps Expiry Group 1
M-M-R(TM) II at intermediate expiry potency
干预措施: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live (Biological)
Control Group
M-M-R(TM) II at current release potency
干预措施: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live (Biological)
Mumps Expiry Group 1
M-M-R(TM) II at intermediate expiry potency
干预措施: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck) (Biological)
Mumps Expiry Group 2
M-M-R(TM) II at expiry potency
干预措施: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live (Biological)
Mumps Expiry Group 2
M-M-R(TM) II at expiry potency
干预措施: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck) (Biological)
结局指标
主要结局
Neutralizing antibodies to mumps at 6 weeks postvaccination
时间窗: 6 weeks postvaccination
次要结局
- Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination(6 weeks and 1 year postvaccination)