Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Malaria; Malaria Vaccines

Treatments: Diagnostic Test: Assessment of body temperature; Procedure: Blood sampling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02251704

116682

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54,115 patients

Sex: All

Ages: 6 months to 9 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54,115 participants in 10 patient groups

Survey 1 Group

Other group

Description:

Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 1.

Treatment:

Procedure: Blood sampling

Diagnostic Test: Assessment of body temperature

Survey 2 Group

Other group

Description:

Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 2.

Treatment:

Procedure: Blood sampling

Diagnostic Test: Assessment of body temperature

Survey 3 Group

Other group

Description:

Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 3.

Treatment:

Procedure: Blood sampling

Diagnostic Test: Assessment of body temperature

Survey 4 Group

Other group

Description:

Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 4.

Treatment:

Procedure: Blood sampling

Diagnostic Test: Assessment of body temperature

Survey 5 Group

Other group

Description:

Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 5.

Treatment:

Procedure: Blood sampling

Diagnostic Test: Assessment of body temperature

Survey 6 Group

Other group

Description:

Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 6.

Treatment:

Procedure: Blood sampling

Diagnostic Test: Assessment of body temperature

Survey 7 Group

Other group

Description:

Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 7.

Treatment:

Procedure: Blood sampling

Diagnostic Test: Assessment of body temperature

Survey 8 Group

Other group

Description:

Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 8.

Treatment:

Procedure: Blood sampling

Diagnostic Test: Assessment of body temperature

Survey 9 Group

Other group

Description:

Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 9.

Treatment:

Procedure: Blood sampling

Diagnostic Test: Assessment of body temperature

Survey 10 Group

Other group

Description:

Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 10.

Treatment:

Procedure: Blood sampling

Diagnostic Test: Assessment of body temperature