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Strengthening the Evidence for Policy on the RTS,S/AS01 Malaria Vaccine
Sponsor: Kintampo Health Research Centre, Ghana
Summary
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.
Official title: Strengthening the Evidence for Policy on the RTS,S/AS01 Malaria Vaccine: Assessment of Safety and Effectiveness Using Case-control Studies Embedded in the Malaria Vaccine Pilot Evaluation
Key Details
Gender
All
Age Range
6 Months - 59 Months
Study Type
OBSERVATIONAL
Enrollment
9280
Start Date
2021-10-18
Completion Date
2025-04-30
Last Updated
2025-02-28
Healthy Volunteers
No
Conditions
Interventions
Case-control study of clinical outcomes
A case-control questionnaire will be administered at the home of cases and controls
Case-control study of mortality outcome
A case-control questionnaire will be administered at the home of cases and controls
Locations (4)
Kintampo Health Research Centre
Kintampo, Ghana
African Research Collaboration for Health Limited
Nairobi, Kenya
Kenya Medical Research Institute (KEMRI)
Nairobi, Kenya
College of Medicine, University of Malawi
Blantyre, Malawi