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
Kintampo Health Research Centre, Ghana
9,280 participants
Oct 18, 2021
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria1
- Caregiver not willing to provide consent
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
A case-control questionnaire will be administered at the home of cases and controls
A case-control questionnaire will be administered at the home of cases and controls
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05041556