Extension to Study MALARIA-055 PRI (NCT00866619) for Evaluation of Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine (SB257049) in Infants and Children in Africa
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,084
- 试验地点
- 3
- 主要终点
- Incidence of Severe Malaria Meeting Case Definition 1
研究概览
简要总结
The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria vaccine in infants and children in Africa following a primary vaccination series (NCT00866619). No new subjects will be enrolled in this extension study.
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
- None
入排标准
- 年龄范围
- 42 Months 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects' parent(s)/ Legally Acceptable Representative (LARs) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Subjects who were enrolled and who received at least one vaccine dose in the primary study MALARIA-055 PRI NCT00866619 and who did not withdraw consent (except those who moved away from the area) during the primary study MALARIA-055 PRI NCT
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject.
排除标准
- •Child in care.
- •Use of any investigational or non-registered product or planned use during the study period.
结局指标
主要结局
Incidence of Severe Malaria Meeting Case Definition 1
时间窗: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).
Incidence of Severe Malaria Meeting Case Definition 2.
时间窗: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).
次要结局
- Incidence of Clinical Malaria Meeting Case Definition(From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076))
- Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.(From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076))
- Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs)(From Year 0 to Year 3 (Starting January 2014 and ending December 2016))
- Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.(From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).)
- Number of Subjects With Cerebral Malaria Meeting Both Case Definitions.(From Year 0 to Year 3 (Starting January 2014 and ending December 2016))
- Number of Subjects With Fatal Malaria Meeting Case Definition 1.(From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).)
- Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS)(At screening, 1 month post Dose 3 (Month 3), 18 months post Dose 3 (Month 20), 1 month post Dose 4 (Month 21), 12 months post Dose 4 (Month 32) (of Malaria-055) and at Years 1, 2 and 3 (of Malaria-076))
- Number of Subjects With Prevalent Parasitemia(At Years 1, 2 and 3)
- Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL)(At Years 1, 2 and 3)
- Incidence of Severe Malaria Meeting Case Definition 1.(From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076))
- Incidence of Severe Malaria Meeting Case Definition 2.(From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076))
- Number of Subjects With Meningitis SAEs(From Year 0 to Year 3 (Starting January 2014 and ending December 2016))
- Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL)(At Years 1, 2 and 3)
- Number of Subjects With Fatal Malaria Meeting Case Definition 2.(From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).)
- Number of Subjects With Cerebral Malaria(From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).)
- Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs(From Year 0 to Year 3 (Starting January 2014 and ending December 2016))