Malaria Paediatrics
Conditions
Interventions
Integrated arm
Sponsors
Epicentre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Control arms (1) Children aged 5-36 months in Burkina Faso and Mali at the time of first study vaccination; (2) Resident in the catchment area of a health centre assigned to the control arm; (3) Willingness to comply with the study procedures; (4) Written informed consent from Parent/Guardian. Intervention arms (1) Children aged 3-59 months at the time of first study vaccination; (2) Resident in the catchment area of a health centre assigned to the intervention arm; (3) Willingness to comply with the study procedures; (4) Written informed consent from Parent/Guardian
Exclusion criteria
Exclusion criteria: (1) History of allergic disease or reactions likely to be exacerbated by any component of the Vaccines; (2) Any history of anaphylaxis in relation to vaccination; (3) Known chronic illness; (4) 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; (5) History of vaccination with another malaria vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Malaria Incidence on 5-36 months at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Malaria incidence among children aged 5-36 months over 24 and 36 months;Malaria incidence among children aged 3-59 months over 24 and 36 months;Malaria prevalence at peak transmission;Vaccine coverage;Occurrence of adverse events (AEs) and serious adverse events (SAEs) following R21/Matrix-M vaccination;Acceptability;Feasibility;Contextual and behavioural factors impeding or facilitating R21/Matrix-M vaccine uptake; Factors that enhance and/or constrain the successful completion of four doses of R21;Cost-effectiveness | — |
Countries
Burkina Faso, Mali
Contacts
Public ContactSoazic Gardais
Project manager
Outcome results
None listed