A Study of M-M-R(TM) II at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age

Merck Sharp & Dohme LLC0 个研究点目标入组 1,997 人开始时间: 1999年2月最近更新: 2015年10月23日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 1,997
主要终点: Neutralizing antibodies to mumps at 6 weeks postvaccination

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

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

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)

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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