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

ConditionMalaria
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-59
SponsorKintampo Health Research Centre, Ghana

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Caregiver not willing to provide consent

Trial design

Treatments tested in this trial

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

Treatment groups

9,280 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Kintampo Health Research Centre, Ghana

Lead sponsor

European Vaccine Initiative

Collaborator

London School of Hygiene and Tropical Medicine

Collaborator

African Research Collaboration for Health Limited

Collaborator

Kenya Medical Research Institute

Collaborator

University of Malawi

Collaborator

PATH

Collaborator