NCT01190202已完成不适用
Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21,618
- 试验地点
- 8
- 主要终点
- Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), for Each Survey
研究概览
简要总结
The aim of this epidemiology study is to characterize in a standardized way malaria transmission intensity at the clinical trial centers participating in study 110021 (NCT00866619).
详细描述
This study is a multicenter epidemiology study at centers that are participating in GSK's pivotal Phase III candidate malaria vaccine 110021 ( NCT00866619) trial and will involve 4 annual cross sectional surveys performed preferably at peak transmission.
There will be no study vaccine administered in this epidemiology study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that they and/or their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- •A male or female 6 months or older at the time of survey.
- •Written informed consent obtained from the subject/from the parent(s)/ Legally Acceptable Representative(s) of the subject.
排除标准
- •Child in care.
- •Previous or current participation in any malaria vaccine trial.
结局指标
主要结局
Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), for Each Survey
时间窗: At each Survey visit
The Overall parasite prevalence (PP) data were collected across centers from subjects aged between and including: 6 months to 4 Years (6M-4Y), 5 to 19 Years (5-19 Y) and 20 Years or older (20Y+), for each Survey. The number of subjects P. Falciparum parasitemia infected among the number of subjects with known result for P.falciparum parasitemia test was tabulated.
次要结局
- Number of Subjects With Anemia and Severe Anemia for Each Survey(During the survey period (approximatively 1 year))
- Number of Subjects With Anti-malarial Therapy in Survey 3, According to Parasite Density(During the survey period (approximatively 1 year))
- Mean Number of Days With Malaria Treatment at Survey 3(During the 14 day-period before the malaria treatment)
- Mean Number of Days With Malaria Treatment at Survey 4(During the 14 day-period before the malaria treatment)
- Mean Number of Days With Malaria Treatment at Survey 1(During the 14 day-period before the malaria treatment)
- Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 3(In the last 24 hours or at the survey visit)
- Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 4(In the last 24 hours or at the survey visit)
- Axillary Temperature at Visit in Survey 1(At Survey visit)
- Axillary Temperature at Visit in Survey 4(At Survey visit)
- Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), According to Annual Age for Children of 4 Years or Less, for Each Survey(At each Survey visit)
- Number of Subjects With Anti-malarial Therapy in Survey 1, According to Parasite Density(During the survey period (approximatively 1 year))
- Number of Subjects With Anti-malarial Therapy in Survey 2, According to Parasite Density(During the survey period (approximatively 1 year))
- Mean Number of Days With Malaria Treatment at Survey 2(During the 14 day-period before the malaria treatment)
- Mean Number of Days With Fever at Survey 1(During the survey period (approximatively 1 year))
- Mean Number of Days With Fever at Survey 4(During the survey period (approximatively 1 year))
- Number of Subjects With Anti-malarial Therapy in Survey 4, According to Parasite Density(During the survey period (approximatively 1 year))
- Mean Number of Days With Fever at Survey 2(During the survey period (approximatively 1 year))
- Axillary Temperature at Visit in Survey 2(At Survey visit)
- Number of Subjects Living in the Same House at Survey 3(At Survey visit)
- Number of Subjects by Localisation and Type of Location at Survey 2(At Survey visit)
- Number of Subjects by Localisation and Type of Location at Survey 3(At Survey visit)
- Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 2(At Survey visit)
- Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 2(At Survey visit)
- Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 1(In the last 24 hours or at the survey visit)
- Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 2(In the last 24 hours or at the survey visit)
- Mean Number of Days With Fever at Survey 3(During the survey period (approximatively 1 year))
- Number of Subjects Living in the Same House at Survey 1(At Survey visit)
- Number of Subjects Living in the Same House at Survey 2(At Survey visit)
- Mean Number of Subjects Living in the Same House at Survey 1(At Survey visit)
- Mean Number of Subjects Living in the Same House at Survey 2(At Survey visit)
- Axillary Temperature at Visit in Survey 3(At Survey visit)
- Mean Number of Subjects Living in the Same House at Survey 3(At Survey visit)
- Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 2(At Survey visit)
- Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 3(At Survey visit)
- Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 3(At Survey visit)
- Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 4(At Survey visit)
- Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 4(At Survey visit)
- Number of Subjects Living in the Same House at Survey 4(At Survey visit)
- Mean Number of Subjects Living in the Same House at Survey 4(At Survey visit)
- Number of Subjects by Localisation and Type of Location at Survey 1(At Survey visit)
- Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 1(At Survey visit)
- Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 4(At Survey visit)
- Number of Subjects by Localisation and Type of Location at Survey 4(At Survey visit)
- Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 1(At Survey visit)
- Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 1(At Survey visit)
- Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 4(At Survey visit)
- Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 3(At Survey visit)
- Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedure for Each Survey(At each Survey visit)
- Number of Subjects With Malaria Prevention Measures (MPM) at Each Survey(At each Survey visit)
- Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 1(At Survey visit)
- Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 2(At Survey visit)
- Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 3(At Survey visit)
研究者
研究点 (8)
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