临床试验/NCT00092404

NCT00092404已完成2 期

A Comparison of the Safety, Tolerability, and Immunogenicity of V205C Manufactured With Recombinant Human Albumin (rHA) Versus V205C Manufactured With Pooled-Donor Human Serum Albumin (HSA) in Healthy Children 12 to 18 Months of Age

Merck Sharp & Dohme LLC0 个研究点目标入组 1,210 人开始时间: 2001年12月最近更新: 2017年3月15日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 1,210
主要终点: Antibody response rates to measles, mumps, and rubella 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 trial is to study the safety and immune response to measles, mumps, and rubella in children who were vaccinated with an investigational measles-mumps-rubella live vaccine made with artificially made human protein.

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

•History or prior exposure to measles, mumps, or rubella
•History of allergic reactions to any component of the vaccines as evaluated by the study doctor

结局指标

主要结局

Antibody response rates to measles, mumps, and rubella at 6 weeks postvaccination

时间窗: 6 weeks postvaccination

次要结局

Geometric mean titers to measles, mumps, and rubella by ELISA at 6 weeks postvaccination(6 weeks 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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