A Phase III, Open-label, Randomized Parallel-group Study on the Immunogenicity and Safety of Quinvaxem® DTwP-HepB-Hib) in Uniject™ With Quinvaxem® Monodose Vials in Healthy Infants at 6, 10 and 14 Weeks of Age

Crucell Holland BV1 个研究点分布在 1 个国家目标入组 400 人开始时间: 2013年9月1日最近更新: 2014年7月15日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 400
试验地点: 1
主要终点: Seroprotection Rate: Anti-PRP Antibodies

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 is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) one (1) month after completion of the 6-10-14 week vaccination course.

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: 42 Days 至 64 Days（Child）
性别: All
接受健康志愿者: 是

入选标准

•A male or female between, and including, 42 and 64 days of age at the time of the first vaccination
•Written informed consent obtained from parents/legal guardians of the subject
•Free of obvious health problems as established by medical history and/or clinical examination before entering the study
•HepB vaccination at birth (within 48 hours)
•Available for all scheduled study visits

排除标准

•Use of any investigational drug or any investigational vaccine in the 30 days preceding the first dose of study vaccine, or their planned use during the study period and safety follow-up
•Planned administration of a vaccine not foreseen by the Study Protocol
•Known or suspected impairment of immune function, known HIV-positivity; actively receiving immunosuppressive therapy, or in receipt of systemic immunosuppressive therapy in the one month prior to study entry (note: inhaled and topical steroids are allowed)
•Administration of parenteral immunoglobulin preparation and/or blood products since birth
•Previous vaccination against Hib and/or DTP
•History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity to any vaccine component or to products containing mercury compounds, such as thiomersal
•Clinically significant acute infection
•Clinically significant acute illness
•Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
•Participation in another clinical study