This is an observational case-control study to assess the effectiveness of the R21/Matrix-M vaccine against severe malaria, clinical malaria (in high transmission perennial areas), and to assess if the R21 vaccine recipients are at an increased risk of deaths (all-cause). Clinical malaria, severe malaria and death (all-cause) cases will be enrolled in study. For each case (severe or death) 4 controls matched for age and neighborhood will be enrolled whereas for clinical malaria case, 1 matched control will be enrolled.
1. Proportion of vaccinated and unvaccinated children amongst Severe Malaria Cases caused by P. falciparum.
2. Proportion of vaccinated and unvaccinated children amongst Clinical Malaria Cases in high-transmission perennial areas caused by P. falciparum.
3. Proportion of vaccinated and unvaccinated children in cases of death (all cause)
4. Exploratory effectiveness endpoint: Proportion of vaccinated and unvaccinated children in the hospitalized clinical and severe malaria cases.
Who can participate
Age range
5 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Parent/legal guardian/ caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.
. Child not meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).
. Received one or more doses of RTS,S/AS01 vaccine in the past.
. Parent/legal guardian/ caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.
. Child meeting any of the case definitions (Severe Malaria, Clinical Malaria).
. Child having history suggestive of clinical malaria in past 30 days (applicable for clinical malaria and severe malaria case-control studies only).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vaccine Effectiveness against Severe Malaria caused by P. falciparum
Timeframe: through study, an average of one year
2
Vaccine Effectiveness against clinical malaria caused by P. falciparum in high perennial transmission areas