Could combining malaria vaccine with seasonal prevention save more kids?
NCT ID NCT07038837
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study in Chad compares two ways of giving the R21 malaria vaccine to children. One group gets the vaccine as part of regular childhood shots, while the other gets it at the same time as seasonal malaria prevention medicine. The goal is to see if the combined approach works just as well and is easier to deliver in areas with high malaria. About 70,000 children will take part over 17 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 70,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 59 months
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * • Routine arm 1. Aged 6 to 11 months at the time of the first R21/MM vaccination (dose 1). 2. Residing in a village participating in the study and randomized to the routine arm. 3. Oral consent provided by the child's parent/guardian. * Synchronised arm <!-- --> 1. Aged 6 to 59 months at the time of the first R21/MM vaccination (dose 1) during the first 3 rounds of SMC (2025). 2. Residing in a village participating in the study and randomized to the synchronized arm. 3. Oral consent provided by the child's parent/guardian. Exclusion Criteria: * Exclusion criteria for both arms according to Chad national EPI guidelines Malaria vaccine is not recommended for children with known severe hypersensitivity: * To a previous dose of a malaria vaccine * To a previous dose of hepatitis B vaccine * One of the components of the R21/MM vaccine Mild illness - including respiratory tract infections, mild diarrhoea and fever below 38.5° C - is not a contraindication to R21/MM vaccination. Malnutrition and being HIV-seropositive are also not contraindications to R21/MM vaccination.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Medecin sans Frontières
RECRUITINGMoïssala, Mandoul Region, Chad
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Other studies related to the condition(s) this trial covers.
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