NCT01470287已完成3 期
A Phase-III, Single Arm, Multi-Center, Open-Label Study to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine (DTwP-Hib-HepB Vaccine) When Administered to Indian Infants at 6, 10, and 14 Weeks of Age
Novartis Vaccines3 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2011年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 3
- 主要终点
- Seroprotection rate one month after the last dose of vaccine administration
研究概览
简要总结
This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male and female subjects ≥ 42 days to ≤ 64 days of age.
- •Written informed consent obtained from either parents/ legal guardian after the nature of the study has been explained according to local regulatory requirements
排除标准
- •Subjects whose parents or legal guardians are unwilling or unable to give written informed consent to participate in the study.
- •History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine.
- •History of anaphylactic shock(immediate hypersensitivity reactions), urticaria or other allergic reactions after previous vaccination or known hypersensitivity to any vaccine component.
- •Administration of parenteral immunoglobulin preparation and/or blood products since birth.
研究组 & 干预措施
Arm 1
Experimental
干预措施: DTwP-HepB-Hib Vaccine (Biological)
结局指标
主要结局
Seroprotection rate one month after the last dose of vaccine administration
时间窗: One month after last vaccination
次要结局
- Seroprotection rate and GMCs one month after the last vaccine administration(One month after last vaccination)
研究者
研究点 (3)
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