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

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.

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.

Inclusion Criteria:

• Participants whose parent(s)/Legally Acceptable Representative(s) [LAR(s)], in the opinion of the investigator, could and would comply with the requirements of the protocol.
• A male or female aged 6 months to under 10 years at the time of the survey.
• Signed informed consent or thumb-printed and witnessed informed consent was obtained from the parent(s)/LAR(s) of the child.

Exclusion Criteria:

• Child was in care.
• Had current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.