A Partially-blind (Observer-blind) Study to Evaluate the Safety and Immunogenicity of 3 Different Vaccination Schedules With 2 GSK Biologicals' Candidate Plasmodium Falciparum Vaccines in Children Aged 5 to 17 Months Living in Ghana

GlaxoSmithKline2 个研究点分布在 1 个国家目标入组 540 人开始时间: 2006年8月30日最近更新: 2018年2月19日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 540
试验地点: 2
主要终点: Number of Subjects With Serious Adverse Events (SAEs)

研究概览研究设计入排标准研究组 & 干预措施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 study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

详细描述

This study will be conducted in a partially blind fashion: it will be observer-blind as to which vaccine was administered, and open as to the vaccination schedule. One group of children on the 0, 1, 2-schedule will receive a Rabies vaccine as a control. One group on the same schedule will receive the RTS,S/AS02D experimental vaccine as an active comparator.

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: 5 Months 至 17 Months（Child）
性别: All
接受健康志愿者: 是

入选标准

•A male or female child between 5 months and 17 months of age at the time of first vaccination.
•Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
•Proof that child has received a full 3-dose regimen of licensed Hepatitis B vaccine in infancy.

排除标准

•Acute disease at the time of enrolment.
•Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
•Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits.
•Planned administration/administration of a vaccine (not in the scope of the study) within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled Yellow fever or Measles vaccine.
•Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of the study vaccine, or planned use during the study period.
•Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
•Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
•Simultaneous participation in any other clinical trial;
•Previous participation in any other malaria vaccine trial;
•Any twins
•History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.

研究组 & 干预措施

SB257049 F2 0-1 M Group

Experimental

Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.