RecruitingNCT05041556

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


Sponsor

Kintampo Health Research Centre, Ghana

Enrollment

9,280 participants

Start Date

Oct 18, 2021

Study Type

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

Min Age: 6 MonthsMax Age: 59 Months

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

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Interventions

OTHERCase-control study of clinical outcomes

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

OTHERCase-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

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