跳至主要内容
临床试验/NCT00307021
NCT00307021已完成2 期

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

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2006年4月7日最近更新:
适应症

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

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.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验