Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

NCT ID: NCT02251704

Last Updated: 2025-07-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-22

Study Completion Date

2024-07-06

Brief Summary

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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

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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

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Malaria Malaria Vaccines

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Survey 1 Group

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.

Group Type OTHER

Assessment of body temperature

Intervention Type DIAGNOSTIC_TEST

Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.

Blood sampling

Intervention Type PROCEDURE

Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.

Survey 2 Group

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.

Group Type OTHER

Assessment of body temperature

Intervention Type DIAGNOSTIC_TEST

Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.

Blood sampling

Intervention Type PROCEDURE

Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.

Survey 3 Group

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.

Group Type OTHER

Assessment of body temperature

Intervention Type DIAGNOSTIC_TEST

Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.

Blood sampling

Intervention Type PROCEDURE

Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.

Survey 4 Group

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.

Group Type OTHER

Assessment of body temperature

Intervention Type DIAGNOSTIC_TEST

Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.

Blood sampling

Intervention Type PROCEDURE

Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.

Survey 5 Group

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.

Group Type OTHER

Assessment of body temperature

Intervention Type DIAGNOSTIC_TEST

Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.

Blood sampling

Intervention Type PROCEDURE

Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.

Survey 6 Group

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.

Group Type OTHER

Assessment of body temperature

Intervention Type DIAGNOSTIC_TEST

Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.

Blood sampling

Intervention Type PROCEDURE

Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.

Survey 7 Group

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.

Group Type OTHER

Assessment of body temperature

Intervention Type DIAGNOSTIC_TEST

Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.

Blood sampling

Intervention Type PROCEDURE

Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.

Survey 8 Group

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.

Group Type OTHER

Assessment of body temperature

Intervention Type DIAGNOSTIC_TEST

Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.

Blood sampling

Intervention Type PROCEDURE

Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.

Survey 9 Group

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.

Group Type OTHER

Assessment of body temperature

Intervention Type DIAGNOSTIC_TEST

Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.

Blood sampling

Intervention Type PROCEDURE

Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.

Survey 10 Group

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.

Group Type OTHER

Assessment of body temperature

Intervention Type DIAGNOSTIC_TEST

Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.

Blood sampling

Intervention Type PROCEDURE

Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.

Interventions

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Assessment of body temperature

Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.

Intervention Type DIAGNOSTIC_TEST

Blood sampling

Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The PATH Malaria Vaccine Initiative (MVI)

OTHER

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Nouna, , Burkina Faso

Site Status

GSK Investigational Site

Ouagadougou, , Burkina Faso

Site Status

GSK Investigational Site

Kintampo, , Ghana

Site Status

GSK Investigational Site

Navrongo, , Ghana

Site Status

GSK Investigational Site

Kisumu, , Kenya

Site Status

GSK Investigational Site

Kisumu, , Kenya

Site Status

GSK Investigational Site

Nairobi, , Kenya

Site Status

GSK Investigational Site

Chikwawa, , Malawi

Site Status

GSK Investigational Site

Mangochi, , Malawi

Site Status

GSK Investigational Site

Dakar, , Senegal

Site Status

GSK Investigational Site

Dakar, , Senegal

Site Status

GSK Investigational Site

Amani, , Tanzania

Site Status

Countries

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Burkina Faso Ghana Kenya Malawi Senegal Tanzania

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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116682

Identifier Type: -

Identifier Source: org_study_id

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