NCT00380393已完成2 期
A Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Biologicals Candidate Vaccine RTS,S/AS01, Administered According to a 0,1,2-months Schedule in Children Aged 5 to 17 Months Living in Tanzania & Kenya
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 894
- 试验地点
- 2
- 主要终点
- Frequency of First Case of Malaria Meeting the Primary Case Definition
研究概览
简要总结
This phase IIb trial is being done to find out if the RTS,S/AS01 vaccine helps to prevent children from falling ill with malaria and to evaluate vaccine safety.
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
- 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 of 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.
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 foreseen by the study within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled diphtheria, pertussis or measles vaccine.
- •Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose
- •Previous participation in any other malaria vaccine trial.
- •Simultaneous participation in any other clinical trial.
- •Same sex twin.
- •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
GSK257049 Group
Experimental
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
干预措施: GSK malaria vaccine 257049 Vaccine (Biological)
Rabipur Group
Active Comparator
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
干预措施: Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine (Biological)
结局指标
主要结局
Frequency of First Case of Malaria Meeting the Primary Case Definition
时间窗: Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)
The first case of malaria meeting the primary case definition was defined as the first or only episodes with the presence of Plasmodium falciparum asexual parasitemia above (\>) 2500 per microliter (μL) and the presence of fever greater than or equal to (≥) 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.
次要结局
- Geometric Mean Density of Asexual P. Falciparum Parasite(At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Multiple Events of Malaria Meeting the Primary Case Definition(Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months))
- Frequency of First Case Malaria Meeting the Secondary Case Definition(Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months))
- Haemoglobin Values at Cross-Sectional Visit(At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months))
- Number of Subjects Positive for P. Falciparum Parasitaemia(At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months))
- Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades(At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29))
- Concentration of Antibodies Against Hepatitis B Surface Antigen (Anti-HBs)(At Day 0 and at Month 3)
- Multiple Events of Malaria Meeting the Secondary Case Definition(Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months))
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects With Serious Adverse Events (SAEs)(Throughout the study period (Day 0 - Month 14))
- Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades(At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29))
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within the 30-day (Days 0-29) post-vaccination follow-up period)
- Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells(At Month 3)
- Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades(At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29))
- Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades(At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29))
- Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades(At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29))
- Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS)(At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29))
- Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells(At Month 3)
研究者
研究点 (2)
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