At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Evaluation of the Pilot Implementation of RTS,S/AS01 Through Routine Health Systems in Moderate to High Malaria Transmission Settings in Africa
In Brief
An observational study evaluating Feasibility survey, Sentinel hospital surveillance, and 1 other intervention for Malaria,Falciparum and 3 related conditions. Completed, enrolled 30,124 participants across 3 sites in 3 countries.
Detailed Summary
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 Details
Timeline
Interventions
A survey questionnaire will be administered at each household. At the baseline household survey, each child aged less than 5 years will be tested for malaria using a rapid malaria test.
Cerebrospinal samples will be collected from all children hospitalised and suspected of having meningitis.
A verbal autopsy will be performed