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Strengthening the Evidence for Policy on the RTS,S/AS01 Malaria Vaccine

Recruitingn/aAges 6 Months - 59 MonthsAllKintampo Health Research Centre, Ghana
NCT05041556 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * Caregiver not willing to provide consent
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What it tests

  • Case-control study of clinical outcomes
  • Case-control study of mortality outcome
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Where

4 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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