NCT02251704|CompletedPhase 4Results

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

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

116682

Study Type

interventional

Target

54,115

Locations

6 countries

Sites

Timeline

RegisteredSep 2014

StartedOct 2014

CompletionJul 2024

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

54,115

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Oct 2014

Longer than P75 for phase_4

Geographic Reach

6 countries

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.7 years study duration

First Submitted

Initial submission to the registry

September 25, 2014

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed

23 days until next milestone

Study Start

First participant enrolled

October 22, 2014

Completed

9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2024

Completed

1 year until next milestone

Results Posted

Study results publicly available

July 24, 2025

Completed

Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

9.7 years

First QC Date

September 25, 2014

Results QC Date

July 4, 2025

Last Update Submit

July 4, 2025

Conditions

Malaria Malaria Vaccines

Keywords

MalariaMTISurveillance studyAfricaRTS,S/AS01EpidemiologyPlasmodium falciparumMalaria control interventions

Outcome Measures

Primary Outcomes (4)

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 Outcomes (11)

Number of Participants Infected With P. Falciparum by Center, Gender and Infection Status
At Day 1 (survey completion visit)
Number of Participants Infected With Plasmodium Species Other Than P. Falciparum
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
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
At Day 1 (survey completion visit)
+6 more secondary outcomes

Study Arms (10)

Survey 1 Group

OTHER

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.