About this trial
The ongoing Malaria Vaccine Pilot Evaluation (MVPE) is being conducted in Ghana, Malawi and Kenya through community and sentinel hospital surveillance systems and a series of household surveys (to measure vaccine coverage). The Malaria Vaccine Pilot Evaluation-Case Control (MVPE-CC) registered here as observational study is embedded within MVPE comprising case-control studies of clinical and mortality outcomes. Each case will require four controls, and caregiver informed consent will be required prior to study activities.
These observational case control studies will measure as complementary information to what is being collected through MVPE:
1. Safety among children who received the malaria vaccine, with focus on cerebral malaria, meningitis and severe malaria 2. The impact of the malaria vaccine on all-cause mortality for boys and girls, AND 3. Promote use of case-control approaches by Expanded Programmes on Immunization (EPI) and malaria control programmes.
Eligibility criteria
Qualifiers
Willingness to participate in study evidenced by written informed consent provided by an adult caregiver
Resident in an RTS,S/AS01 implementation area within the catchment area of MVPE sentinel hospitals
Eligible, based on date of birth and age, to have received RTSS/AS01
Meets the case or control definitions above.
Disqualifiers
Caregiver not willing to provide consent
Trial design
Treatments tested in this trial
- Case-control study of clinical outcomes
- Case-control study of mortality outcome
Treatment groups
Sponsors and collaborators
Kintampo Health Research Centre, Ghana
Lead sponsor
European Vaccine Initiative
Collaborator
London School of Hygiene and Tropical Medicine
Collaborator
African Research Collaboration for Health Limited
Collaborator
Kenya Medical Research Institute
Collaborator
University of Malawi
Collaborator
PATH
Collaborator