Last Updated: 04/11/2025
An epidemiology study to assess Plasmodium falciparum parasite prevalence and malaria control measures in catchment areas of two studies introduction to assess in field conditions and vaccine benefit: risk in children in sub-Sahara Africa
Objectives
- To obtain longitudinal estimates of P. falciparum parasite prevalence in order to characterise malaria transmission intensity in a standardised way at centres conducting the EPI-MAL-002 and EPI-MAL-003 studies before and after the introduction of the malaria vaccine RTS,S/AS01E in sub-Saharan Africa.
- To obtain longitudinal estimates of the use of malaria control interventions in centres conducting the EPI-MAL- 002 and EPI-MAL-003 studies before and after the introduction of the malaria vaccine RTS,S/AS01E in sub-Saharan Africa.
This epidemiology study (EPI-MAL-005) is planned to run in parallel with two conservative safety monitoring vaccine studies (EPI-MAL-002 and EPI-MAL-003) which will monitor incidence rate of protocol defined adverse events of specific interest (AESI) and non-communicable and traumatic serious adverse events (NC/NT-SAE).
Study type: Interventional
Enrollment: 54000 participants
Interventional Model: Single group assignment
Masking: open label
NCT number: NCT02251704
Phase: Phase IV
Estimating Annual Fluctuations in Malaria Transmission Intensity and in the Use of Malaria Control Interventions in Five Sub-Saharan African CountriesArticle: Assessing the safety, impact and effectiveness of RTS,S/AS01E malaria vaccine following its introduction in three sub-Saharan African countries: methodological approaches and study set-up
Sep 2014 — Nov 2023
$2.5M
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