NCT02251704

Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

An Epidemiology Study to Assess Plasmodium Falciparum Parasite Prevalence and Malaria Control Measures in Catchment Areas of Two Interventional Studies Pre- and Post RTS,S/AS01E Introduction (EPI MAL-002 and EPI-MAL-003) to Assess, in Field Conditions, Vaccine Benefit: Risk in Children in Sub Saharan Africa

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54,115 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Months – 9 Years
• Healthy volunteers: Accepted

Summary

This epidemiology study was conducted in parallel with the EPI-MAL-002 (NCT02374450) and EPI-MAL-003 (NCT03855995) studies, enrolling participants from the same health and demographic surveillance system (HDSS) (or equivalent system) populations. The co-primary objectives were to produce longitudinal estimates of parasite prevalence in humans and to record the usage of malaria control measures in areas where the EPI-MAL-002 and EPI-MAL-003 studies were conducted.

Detailed description

This study involved 10 annual cross-sectional surveys conducted during malaria peak transmission seasons. The surveys provided point estimates of parasite prevalence and subsequently enabled a longitudinal assessment of the level of endemicity in each area covered by EPI-MAL-002 and EPI-MAL-003. The study was conducted in parallel with EPI-MAL-002 and EPI-MAL-003 to assess parasite prevalence and malaria control measures before (EPI-MAL-002) and after (EPI-MAL-003) vaccine introduction. By taking into account variations in malaria transmission intensity (MTI) and malaria control intervention coverage, it enabled a more complete assessment of the benefits and risks of the vaccine introduction, and thereby provided greater insight into the potential vaccine impact in EPI-MAL-002/-003 by adjusting incidence data for overall changes in transmission and other malaria control intervention coverage, and assisted in the generalisation of results to other populations.

Conditions

• Malaria
• Malaria Vaccines

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Assessment of body temperature	Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
PROCEDURE	Blood sampling	Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.

Timeline

• Start date: 2014-10-22
• Primary completion: 2024-07-06
• Completion: 2024-07-06
• First posted: 2014-09-29
• Last updated: 2025-07-24
• Results posted: 2025-07-24

Locations

12 sites across 6 countries: Burkina Faso, Ghana, Kenya, Malawi, Senegal, Tanzania