This is a two-arm, cluster-randomised, phase IV trial conducted in Chad to assess theprotective efficacy and impact in real-life conditions of a new strategy foradministering the R21/MM malaria vaccine, synchronized within a seasonal malariachemoprevention (SMC) campaign, among children living in areas of high seasonal malariatransmission.In this study, a cluster is defined as the catchment area of a primary care healthcentre. In Chad, each catchment area is known as a 'zone of responsibility' (French: Zonede Responsibilité' [ZR]).Twenty-six (26) of the total 27 ZRs in the districts of Moïssala and Dembo will berandomized in a 1:1 ratio to receive a 4-dose (3 primary doses + 1 booster) R21/MMschedule either (1) integrated into the routine EPI vaccination program (the "Routine"control arm), or (2) synchronized with an annual seasonal malaria chemoprevention (SMC)campaign (the "Synchronized" intervention arm).Malaria incidence: R21/MM effectiveness will be assessed using the incidence ofbiologically confirmed clinical malaria (trial primary endpoint). The incidence ofclinical malaria will be determined through enhanced surveillance of malaria cases inhealth centres and hospitals over a 17-month period (August 2025 - December 2026).Coverage surveys: Cross-sectional surveys (cluster sampling) will be carried out tomeasure R21/MM vaccine coverage, SMC coverage, coverage of other malaria preventionmeasures, and coverage of other EPI vaccines.Nested case-control study: A sub-sample of children admitted to Moïssala DistrictHospital with severe clinical malaria will be offered the opportunity to participate in anested case-control study designed to estimate the individual protective efficacy ofR21/MM against severe malaria.
Not Provided
Other: "Synchronised" arm (intervention)
Vaccines received together with CPS
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.
Medecin sans Frontières
Moissala, Mandoul region, Chad
Investigator: Ouattara San Maurice
Contact: +235 85 15 76 18
San-Maurice.OUATTARA@epicentre.msf.org
Todd SWARTHOUT, Dr
+331 40 21 55 55
todd.swarthout@epicentre.msf.org
San Maurice OUATTARA
+235 85 15 76 18
San-Maurice.OUATTARA@epicentre.msf.org
Not Provided