Malaria
Conditions
Interventions
Synchronised arm
Sponsors
Medecins sans frontieres
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for vaccination - routine arm (1) Aged 6 to 11 months at the time of the first R21/MM vaccination (dose 1). (2) Residing in one of the 13 ZRs randomised to the trial’s routine arm. (3) Oral consent provided by the child’s parent/guardian. Inclusion criteria for vaccination - synchronised arm (1) Children aged 6 to59 months at the time of the first R21/MM vaccination (dose 1). (2) Residing in one of the 13 ZRs randomised to the synchronised arm. (3) Oral consent provided by the child’s parent/guardian.
Exclusion criteria
Exclusion criteria: Exclusion criteria for vaccination in both arms of the study (according to national EPI guidelines) • R21/MM malaria vaccines are not recommended for children with known severe hypersensitivity: o To a previous dose of the malaria vaccine o To a previous dose of hepatitis B vaccine o One of the components of the vaccine • Mild illness - including respiratory tract infections, mild diarrhoea and fever below 38.5oC - is not a contraindication to R21/MM vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main objective: To assess whether the R21/MM vaccine synchronized with SMC is non-inferior in preventing malaria (based on malaria incidence) compared to R21/MM administered as part of routine EPI in children who were aged 6-11 months when receiving their first dose R21/MM. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the impact of R21/MM vaccination synchronized with SMC compared to R21/MM administered as part of routine EPI in preventing malaria (based on malaria incidence) in children aged 6-59 months and irrespective of R21/MM vaccination status.;R21/MM vaccine coverage To estimate and compare R21/MM vaccination coverage in each arm of the study. To estimate and compare R21/MM drop-out rates between dose 1 and dose 3 and between dose 3 and dose 4 (booster) in each study arm. To describe the reasons for R21/MM non-vaccination among children eligible for R21/MM vaccination in each arm of the study. Compare R21/MM coverage according to the child's place of residence (located <5 km vs =5 km from the nearest health facility). ;Impact of R21/MM implementation strategies on other malaria prevention measures To estimate and compare SMC coverage in each arm of the study. To estimate and compare the coverage and use of long-lasting insecticidal nets (LLIN) in each arm of the study. To estimate and compare the coverage of other vaccine antigens administered as part of the EPI at 9 and 15 months of age (measles 1, measles 2) in each arm of the study. To compare the coverage of other preventive measures (SMC, LLIN, other vaccine antigens) according to the child's place of residence (<5 km vs. =5 km from the nearest health facility). ;Protective efficacy of R21/MM against severe malaria To estimate the individual protective efficacy of R21/MM against confirmed severe malaria, using a case-control study ;Impact of R21/MM in reducing all-cause morbidity To compare the proportion of all-cause morbidity registered at health centres attributed to uncomplicated malaria among children aged 6-59 months in each arm of the study.; R21/MM safety To describe the occurrence of serious adverse events (SAE), adverse events following immunization (AEFI) and adverse events of special interest (AESI) after vaccination with the R21/MM vaccine in each arm of the study, | — |
Countries
Chad
Contacts
Public ContactJessica Sayyad
PI
Outcome results
None listed