Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Epicentre
- 入组人数
- 40,000
- 试验地点
- 2
- 主要终点
- Malaria Incidence on 5-36 months at 12 months
研究概览
简要总结
This is a multi-site, multi-disciplinary, Phase-4 two-arm cluster-randomised non-inferiority trial in Burkina Faso and Mali to evaluate the effectiveness and real-life impact of a novel integrated delivery strategy of the R21 malaria vaccine alongside SMC among children in areas with highly seasonal malaria transmission. In this study, a cluster is defined as the catchment area of a health centre. Clusters will be randomised to receive either year-round age-based routine EPI vaccination for children aged 5-36 months ("Routine EPI Vaccination") in Burkina Faso or an annual campaign of the 3-dose primary series in children aged 5-36 months prior to the malaria season and SMC delivery (''Routine Pre-SMC vaccination'') in Mali versus an annual campaign of the 3-dose primary series aligned with SMC distribution in children aged 3-59 months ("Integrated SMC Vaccination") in each country. Effectiveness will be assessed in terms of clinical malaria, vaccine coverage, acceptability, feasibility, and cost-effectiveness.
Malaria incidence will be determined using routine surveillance activities for clinical malaria detection and reporting in each country. Cross-sectional surveys will be conducted to determine the prevalence of parasitaemia in the communities. In addition, the acceptability, feasibility, coverage and cost-effectiveness of the different delivery systems of R21/Matrix-M will be assessed.
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
- 3 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Control arms :
- •Children aged 5-36 months in Burkina Faso and Mali at the time of first study vaccination;
- •Resident in the catchment area of a health centre assigned to the control arm;
- •Willingness to comply with the study procedures;
- •Written informed consent from Parent/Guardian.
- •Intervention arms :
- •Children aged 3-59 months at the time of first study vaccination;
- •Resident in the catchment area of a health centre assigned to the intervention arm;
- •Willingness to comply with the study procedures;
- •Written informed consent from Parent/Guardian.
排除标准
- •History of allergic disease or reactions likely to be exacerbated by any component of the Vaccines;
- •Any history of anaphylaxis in relation to vaccination;
- •Known chronic illness;
- •Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial;
- •History of vaccination with another malaria vaccine. -
结局指标
主要结局
Malaria Incidence on 5-36 months at 12 months
时间窗: from enrollment to 12 months
Malaria incidence among children aged 5-36 months over 12 months post first dose using routine surveillance activities for clinical malaria detection and reporting
次要结局
- Malaria incidence among children aged 5-36 months over 24 and 36 months(From enrollment to 2 years after booster)
- Malaria incidence among children aged 3-59 months over 24 and 36 months(From enrollment to 2 years after booster)
- Malaria prevalence at peak transmission(From enrollment to 2 years after booster dose)
- Vaccine coverage(From enrollment to months 24)
- Occurrence of adverse events (AEs) and serious adverse events (SAEs) following R21/Matrix-M vaccination;(From enrollment to months 4)
- Acceptability(From 12 months after study start to 36 months)
- Stakeholder perceptions of the feasibility on the vaccine delivery strategy in each group(From enrollment to months 36)
- Contextual and behavioural factors impeding or facilitating R21/Matrix-M vaccine uptake(From enrollment to months 24)
- Stakeholders and caregivers perceptions of the factors that enhance and/or constrain the succesful co,pletion of four doses of R21 and the key drivers of vaccination coverage(From enrollment to months 24 and 36)
- Incremental costs (per child vaccinated) and cost-effectiveness (per malaria case and separately, per DALY averted) of each vaccination strategy, calculated from a societal perspective(From enrollment to months 36)