Phase 4
N=54,100
Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
Malaria · Malaria Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT02251704 ↗Enrolled (actual)
54,100
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Number of Participants Infected With Plasmodium Falciparum (P. Falciparum) by World Health Organisation (WHO) Age Group — 98; 148; 82; 46 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Assessment of body temperature (Diagnostic_test); Blood sampling (Procedure)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Infected With Plasmodium Falciparum (P. Falciparum) by World Health Organisation (WHO) Age Group |
98; 148; 82; 46; 46; 54 | — |
| PRIMARY Number of Participants Infected With P. Falciparum by Joint Technical Expert Group (JTEG) Age Group |
249; 321; 198; 135; 162; 182 | — |
| PRIMARY Number of Participants Using Malaria Control Interventions: Bednet Usage and Type of Bednet |
3768; 3628; 2152; 2733; 4805; 5140 | — |
| PRIMARY Number of Participants Using Malaria Control Interventions: Mosquito Coils, Insecticide Sprays, Commercial Repellants, Traditional Repellants and Indoor Residual Sprays |
246; 305; 150; 359; 452; 808 | — |
| SECONDARY Number of Participants Infected With P. Falciparum by Center, Gender and Infection Status |
199; 251; 172; 132; 204; 237 | — |
| SECONDARY Number of Participants Infected With Plasmodium Species Other Than P. Falciparum |
62; 128; 58; 57; 39; 87 | — |
| SECONDARY 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 |
2922; 3688; 2029; 2728; 5165; 5562 | — |
| SECONDARY Number of Participants Who Received Anti-malarial Therapy or Any Other Medication Within 14 Days Prior to the Study Visit |
700; 672; 455; 661; 1295; 1041 | — |
| SECONDARY Number of Participants With Measured Fever at the Time of Their Study Visit |
215; 200; 94; 127; 245; 223 | — |
| SECONDARY Number of Participants With Reported Fever in the 24 Hours Prior to Their Study Visit |
1060; 1082; 624; 822; 1307; 1162 | — |
| SECONDARY Number of Participants Demonstrating Care-seeking Behavior Following Reported Fever or Malaria up to 14 Days Prior to Their Study Visit |
117; 102; 42; 88; 209; 194 | — |
| SECONDARY Number of Participants in Each Geo-referenced Segment |
21; 58; 11; 30; 50; 66 | — |
| SECONDARY Number of Participants Experiencing Malaria Risk Factors Categorized by the Number of Participants Living in the Same House (by Parasite Density) |
180; 161; 124; 109; 84; 93 | — |
| SECONDARY Number of Participants Experiencing Malaria Risk Categorized by Location (by Parasite Density) |
449; 559; 512; 484; 485; 559 | — |
| SECONDARY Number of Participants Experiencing Malaria Risk Factors Categorized by House Information (by Parasite Density) |
417; 500; 218; 257; 217; 322 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02251704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.