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.

Study Overview

• Status: Completed
• Conditions: Malaria; Malaria Vaccines
• Intervention / Treatment: Procedure: Blood sampling; Diagnostic test: Assessment of body temperature

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.

• Study Type: Interventional
• Enrollment (Actual): 54115
• Phase: Phase 4

Contacts and Locations

Study Locations

• Burkina Faso
  • Nouna, Burkina Faso
    • GSK Investigational Site
  • Ouagadougou, Burkina Faso, 2208
    • GSK Investigational Site
• Ghana
  • Kintampo, Ghana
    • GSK Investigational Site
  • Navrongo, Ghana
    • GSK Investigational Site
• Kenya
  • Kisumu, Kenya, 40100
    • GSK Investigational Site
  • Kisumu, Kenya, 40102
    • GSK Investigational Site
  • Nairobi, Kenya, 40100
    • GSK Investigational Site
• Malawi
  • Chikwawa, Malawi
    • GSK Investigational Site
  • Mangochi, Malawi
    • GSK Investigational Site
• Senegal
  • Dakar, Senegal, 12500
    • GSK Investigational Site
  • Dakar, Senegal, 16556
    • GSK Investigational Site
• Tanzania
  • Amani, Tanzania
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 9 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Procedure: Blood sampling; Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.; Diagnostic test: Assessment of body temperature; Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Other: 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.	Procedure: Blood sampling; Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.; Diagnostic test: Assessment of body temperature; Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Other: 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.	Procedure: Blood sampling; Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.; Diagnostic test: Assessment of body temperature; Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Other: 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.	Procedure: Blood sampling; Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.; Diagnostic test: Assessment of body temperature; Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Other: 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.	Procedure: Blood sampling; Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.; Diagnostic test: Assessment of body temperature; Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Other: 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.	Procedure: Blood sampling; Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.; Diagnostic test: Assessment of body temperature; Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Other: 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.	Procedure: Blood sampling; Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.; Diagnostic test: Assessment of body temperature; Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Other: 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.	Procedure: Blood sampling; Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.; Diagnostic test: Assessment of body temperature; Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Other: 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.	Procedure: Blood sampling; Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.; Diagnostic test: Assessment of body temperature; Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Other: 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.	Procedure: Blood sampling; Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.; Diagnostic test: Assessment of body temperature; Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Infected With Plasmodium Falciparum (P. Falciparum) by World Health Organisation (WHO) Age Group	The number of participants was summarized by the WHO age group (0.5-1 year [Y] and 2-9Y) and by center number/ country [Burkina Faso (BF), Senegal (SN), Tanzania (TZ), Kenya (KE), Ghana (GH), Malawi (MA)]/ city. Unexposed (UNEXP) sites are the ones in which the RTS,S vaccine was not planned to be implemented during the course of the study however, vaccinated participants could still have been randomly selected in this population if vaccination happened in an exposed (EXP) site, due to cross-site migration. The infection was identified using a blood smear slide and determined using microscopy.	At Day 1 (survey completion visit)
Number of Participants Infected With P. Falciparum by Joint Technical Expert Group (JTEG) Age Group	The number of participants was summarized by the JTEG age group (0.5-4Y and 5-9Y) by center number/ country [BF, SN, TZ, KE, GH, MA]/ city. UNEXP sites are the ones in which the RTS,S vaccine was not planned to be implemented during the course of the study however, vaccinated participants could still have been randomly selected in this population if vaccination happened in an EXP site, due to cross-site migration. The infection was identified using a blood smear slide and determined using microscopy.	At Day 1 (survey completion visit)
Number of Participants Using Malaria Control Interventions: Bednet Usage and Type of Bednet	The number of participants using malaria control interventions was summarized by: participants sleeping under a mosquito net the night before their visit, participants who have a new bednet (less than 1 year), participants who have a impregnated bednet (dipped in liquid to repel mosquitos after purchase), participants who have a pierced/torn bednet, participants with bednets classified by hole size (defined as holes big enough to let one finger go through) and number of holes (less than [<] 5 holes, more or equal [>=] to 5 holes, not applicable [NA] which is a participant who did not sleep under a bed net, missing confirmed [MC] which is a participant who slept under a mosquito net but who didn't answer to the question on holes).	At Day 1 (survey completion visit)
Number of Participants Using Malaria Control Interventions: Mosquito Coils, Insecticide Sprays, Commercial Repellants, Traditional Repellants and Indoor Residual Sprays	The number of participants using malaria control interventions was summarized by: mosquito coils, insecticide sprays, commercial repellants, traditional repellants and indoor residual sprays (in the past 12 months, 1 to 12 months, NA [the participant didn't use the residual spray], missing [participant used spray but didn't answer to how long ago]).	At Day 1 (survey completion visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Infected With P. Falciparum by Center, Gender and Infection Status	The number of participants was summarized by: center number/ country [BF, SN, TZ, KE, GH, MA]/ city, gender (female, male) and infection status (infected, not infected).	At Day 1 (survey completion visit)
Number of Participants Infected With Plasmodium Species Other Than P. Falciparum	The infections with other Plasmodium species were determined using a blood smear slide and microscopy. The number of participants infected with P. malaria, P. vivax and P. ovale was summarized.	At Day 1 (survey completion visit)
Number of Participants Who Received Dose 3 of the Diphtheria, Tetanus, Pertussis/ Hepatitis B/ Haemophilus Influenzae Type b (DTP/HepB/Hib) Vaccine or Dose 1 of the Measles Vaccine		At Day 1 (survey completion visit)
Number of Participants Who Received Anti-malarial Therapy or Any Other Medication Within 14 Days Prior to the Study Visit	The number of participants who received anti-malarial therapy out of those who reported malaria in the last 14 days prior to the study visit was summarized.	Up to 14 days prior to the study visit at Day 1
Number of Participants With Measured Fever at the Time of Their Study Visit	Fever was defined as an axillary temperature of 37.5°C or higher.	At Day 1 (survey completion visit)
Number of Participants With Reported Fever in the 24 Hours Prior to Their Study Visit	Fever was defined as an axillary temperature of 37.5°C or higher.	Up to 24 hours prior to their study visit at Day 1
Number of Participants Demonstrating Care-seeking Behavior Following Reported Fever or Malaria up to 14 Days Prior to Their Study Visit	The number of participants demonstrating care-seeking behavior following reported fever or malaria was summarized by where the participant was taken for treatment (home, drug seller, pharmacy, private clinic, health center, hospital, other, not applicable [no treatment received]), by when the participant was taken for treatment (at onset, when the participant did not improve, when the participant got worse, other, not applicable [no treatment received], missing [participant was taken for treatment but did not answer the question regarding when]) and by what time the participant was taken for treatment (the same day, the next day, 2 days later, more than 2 days later, not applicable [no treatment received], missing [participant was taken for treatment but did not answer the question regarding the time]).	Up to 14 days prior to their study visit at Day 1
Number of Participants in Each Geo-referenced Segment	The number of participants was summarized by: center number/ country [BF, SN, TZ, KE, GH, MA]/ city followed by the segment ID. Positioning of the participant's residence was attributed to a segment with a unique ID from the grid referencing study area map in which the participant resided; where necessary, grouping small geographically proximate villages so that each segment had at least 10 study participants to avoid personally identifiable information (PII), and proceeding as far as geographically appropriate.	At Day 1 (survey completion visit)
Number of Participants Experiencing Malaria Risk Factors Categorized by the Number of Participants Living in the Same House (by Parasite Density)	Participants were categorized by the number of people living in the same house relative to enrolled participants as follows: less than of equal to (<=) 3 per 1 enrolled (LE 3/1), 4-5 per 1 (4-5/1), more than (>) 5 per 1 (GT 5/1); <=3 per 2 enrolled (LE 3/2), 4-5 per 2 (4-5/2), >5 per 2 (GT 5/2); <=3 per 3 enrolled (LE 3/3), 4-5 per 3 (4-5/3), >5 per 3 (GT 5/3); 4-5 per more than 3 enrolled (4-5/GT 3), >5 per more than 3 enrolled (GT 5/GT 3). Participants were also categorized by parasite density: low (<2500 parasites/μL), medium (2500-9999/μL), high (10000-19999/μL), very high (>=20000/μL), negative, and missing.	At Day 1 (survey completion visit)
Number of Participants Experiencing Malaria Risk Categorized by Location (by Parasite Density)	Participants were categorized by location as follows: situation area (rural, urban, semi-rural) and type of location (large city, small city, town, countryside). Participants were also categorized by parasite density: low (<2500 parasites/μL), medium (2500-9999/μL), high (10000-19999/μL), very high (>=20000/μL), negative, and missing.	At Day 1 (survey completion visit)
Number of Participants Experiencing Malaria Risk Factors Categorized by House Information (by Parasite Density)	Participants were categorized by house characteristics as follows: wall material (mud, brick, cement/plaster, clay, other), floor material (natural, rudimentary, vinyl/asphalt strips, parquet/polished wood, ceramic tiles, cement, carpet, clay, other), roof type (iron sheet, tiles, clay, other), window type (closed, open, no window, partially open, other), presence of nets (not present, present on all windows, present on some windows, other, missing), main drinking water source (closed, open), whether the open source was in the compound (yes, no, not available [NA]), and presence or absence of electricity. Participants were also categorized by parasite density: low (<2500 parasites/μL), medium (2500-9999/μL), high (10000-19999/μL), very high (>=20000/μL), negative, and missing.	At Day 1 (survey completion visit)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: The PATH Malaria Vaccine Initiative (MVI)
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2014
• Primary Completion (Actual): July 6, 2024
• Study Completion (Actual): July 6, 2024

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimated): September 29, 2014

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Malaria; Plasmodium falciparum; Epidemiology; Africa; RTS,S/AS01; MTI; Surveillance study; Malaria control interventions
• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Infections; Protozoan Infections; Parasitic Diseases; Malaria
• Other Study ID Numbers: 116682

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No