Study to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC Given With Infanrix™ Penta Versus NeisVac-C™ Given With Infanrix™ Hexa at 3, 5 Months of Age and Persistence Prior to a Hib-MenC Booster at 11 Months and Immunogenicity of the Booster
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 709
- 试验地点
- 17
- 主要终点
- SBA-MenC titre
研究概览
简要总结
The purpose of this primary vaccination phase is to demonstrate the non-inferiority of two doses of Biologicals' Hib-MenC conjugate vaccine when given with Infanrix™ penta to infants (at 3 & 5m) compared to NeisVac-C™ given with Infanrix™ hexa.
The purpose of the booster vaccination phase is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC vaccine given with Infanrix™ penta at 11 m of age versus NeisVac-C™ given with Infanrix™ hexa, as well as the antibody persistence prior to the administration of the booster doses. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
This multicenter study is open and consists of a primary and a booster phase. The study has 2 treatment groups with NeisVac-C™ + Infanrix™ hexa as active controls. In the primary phase, one blood sample will be collected from all subjects for immunogenicity analyses- one month after the second vaccination dose. In the booster phase, two blood samples will be collected: prior to and one month post booster vaccination.
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 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
SBA-MenC titre
时间窗: One month after the second dose of the Primary Vaccination Phase.
Anti-PRP concentration
时间窗: One month after the second dose of the Primary Vaccination Phase
次要结局
- Occurrence of any serious adverse events(Throughout the study.)
- SBA-MenC titres(One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination)
- Anti-PRP concentrations(One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination)
- Anti-PSC concentrations(One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination.)
- Anti-HBs concentrations(One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination)
- Occurrence of local solicited adverse events.(During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose.)
- Occurrence of solicited general adverse events(During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose.)
- Occurrence of unsolicited non-serious adverse events(Within 30 days after each vaccination)