Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix (dTpa) Vaccine and the Chinese DT Vaccine, When Administered as Booster Vaccination in Healthy Children Aged 6-8 Years

GlaxoSmithKline1 个研究点分布在 1 个国家目标入组 660 人开始时间: 2007年3月最近更新: 2016年10月28日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 660
试验地点: 1
主要终点: Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals' reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in comparison with Chinese DT vaccine, in children 6-8 years of age.

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: None

入排标准

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

入选标准

•A male or female between, and including, 6-8 years of age at the time of vaccination,
•Written informed consent obtained from the parent or guardian of the subject,

排除标准

•Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate.
•Subjects with history of diphtheria, pertussis or tetanus diseases can not participate.

结局指标

主要结局

Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration.

次要结局

Solicited symptoms (Day 0-3), unsolicited AEs (Day 0-30) & SAEs

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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