Study identification

EU PAS number

EUPAS42048

Study ID

42049

Official title and acronym

An Evaluation of the Pilot Implementation of RTS,S/AS01 Through Routine Health Systems in Moderate to High Malaria Transmission Settings in Africa (Malaria Vaccine Pilot Evaluation ( MVPE ))

DARWIN EU® study

No

Study countries

Ghana
Kenya
Malawi

Study description

The RTS,S/AS01 malaria vaccine is being introduced sub-nationally in phased pilot introductions through the EPI programmes in Malawi Ghana and Kenya. Vaccine introduction is by the respective MoH in selected areas randomly assigned to receive the vaccine at the beginning of the pilots. In the context of this programmatic activity, the Malaria Vaccine Pilot Evaluation (MVPE) registered here as observational evaluations during early vaccine introduction, include a series of 3 household surveys, and sentinel hospital and community mortality surveillance, building on routine systems. These observational evaluations will measure: 1. The programmatic feasibility of delivering a 4 dose schedule, 2. Safety in routine use, with focus on cerebral malaria and meningitis, 3. The impact of the malaria vaccine in routine use on severe malaria and all-cause mortality

Study status

Ongoing
Research institutions and networks

Institutions

Ghana Kintampo Health Research Centre, Ghana, College of Medicine, School of Public Health, University of Malawi Malawi, CDC-Kenya Malaria Research Program Kenya

Contact details

Mary Jean Hamel

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

GAVI, UNITAID, Global Fund
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)