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RECRUITINGOBSERVATIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Willingness to participate in study evidenced by written willing to sign a consent form 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. Who Should NOT Join This Trial: - Caregiver not willing to provide consent Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

Case-control study of clinical outcomes

A case-control questionnaire will be administered at the home of cases and controls

OTHER

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