A Registration Study of the Safety, Tolerability, and Immunogenicity of V441 in Healthy Infants in Taiwan

Merck Sharp & Dohme LLC0 个研究点目标入组 151 人开始时间: 2002年3月最近更新: 2015年10月7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: 151
主要终点: Tolerability and immune responses adequate to be protective against diphtheria, tetanus, pertussis, polio, Haemophilus Influenzae Type B, and Hepatitis B.

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 evaluate the safety, tolerability, and immune response of an investigational vaccine being evaluated to reduce the incidence of diphtheria, pertussis, tetanus, hepatitis B, poliomyelitis, and Haemophilus influenza type b.

详细描述

The duration of treatment is 65 weeks.

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: None

入排标准

年龄范围: 6 Weeks 至 8 Weeks（Child）
性别: All
接受健康志愿者: 是

入选标准

•Healthy infant who received Hepatitis B vaccine within 5 days of birth and whose mother is negative to Hepatitis B surface antigen

排除标准

•Problems with immune system
•Recent illness with fever

结局指标

主要结局

Tolerability and immune responses adequate to be protective against diphtheria, tetanus, pertussis, polio, Haemophilus Influenzae Type B, and Hepatitis B.

次要结局

未报告次要终点

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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