Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Occurrence of SAEs.
研究概览
简要总结
GSK Biologicals is developing a number of candidate malaria vaccines for the routine immunization of infants and children living in malaria-endemic areas. The candidate vaccines are designed to offer protection against malaria disease due to the parasite Plasmodium falciparum. Candidate vaccines containing the RTS,S antigen would also provide protection against infection with hepatitis B virus (HBV). This study will evaluate two candidate vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 48 Months(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
Occurrence of SAEs.
时间窗: From the time of first vaccination until one month post Dose 3
Antibody titers to the P. falciparum circumsporozoite repeat domain (anti-CS).
时间窗: One month post Dose 3.
次要结局
- Anti-Hepatitis B surface agent (anti-HBs) antibody titers.(Prior to vaccination, one month post Dose 2 and one month post Dose 3.)
- Occurrence of unsolicited symptoms.(After each vaccination over a 30-day follow-up)
- Anti-CS antibody titers.(Prior to vaccination, one month post Dose 2)
- Occurrence of solicited general and local reactions.(Over a 7-day follow-up period after each vaccination.)
