MalariaPhase 4NCT02251704
Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
A Phase 4 study testing Assessment of body temperature and Blood sampling in people with Malaria and Malaria Vaccines, run by GlaxoSmithKline at 12 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Malaria Vaccines
- What is being tested?
- Assessment of body temperature and Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54,115 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 22 Oct 2014to 6 Jul 2024
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Child was in care.
- Had current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
Kenya3 sites
GSK Investigational Site
Kisumu, 40100
GSK Investigational Site
Kisumu, 40102
GSK Investigational Site
Nairobi, 40100
Burkina Faso2 sites
GSK Investigational Site
Nouna
GSK Investigational Site
Ouagadougou, 2208
Malawi2 sites
GSK Investigational Site
Chikwawa
GSK Investigational Site
Mangochi
Senegal2 sites
GSK Investigational Site
Dakar, 12500
GSK Investigational Site
Dakar, 16556
About this study
Official title: 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.
Read the 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.
- Conditions
- Malaria, Malaria Vaccines
- Being tested
- Assessment of body temperature, Blood sampling
- Keywords
- Malaria, MTI, Surveillance study, Africa, RTS,S/AS01, Epidemiology, Plasmodium falciparum, Malaria control interventions
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of body temperatureDiagnostic test
Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Blood samplingProcedure or surgery
Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Assessment of body temperature; Procedure: Blood sampling |
| Survey 2 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 2. Receives: Diagnostic Test: Assessment of body temperature; Procedure: Blood sampling |
| Survey 3 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 3. Receives: Diagnostic Test: Assessment of body temperature; Procedure: Blood sampling |
| Survey 4 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 4. Receives: Diagnostic Test: Assessment of body temperature; Procedure: Blood sampling |
| Survey 5 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 5. Receives: Diagnostic Test: Assessment of body temperature; Procedure: Blood sampling |
| Survey 6 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 6. Receives: Diagnostic Test: Assessment of body temperature; Procedure: Blood sampling |
| Survey 7 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 7. Receives: Diagnostic Test: Assessment of body temperature; Procedure: Blood sampling |
| Survey 8 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 8. Receives: Diagnostic Test: Assessment of body temperature; Procedure: Blood sampling |
| Survey 9 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 9. Receives: Diagnostic Test: Assessment of body temperature; Procedure: Blood sampling |
| Survey 10 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 10. Receives: Diagnostic Test: Assessment of body temperature; Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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]).
Measured: At Day 1 (survey completion visit)
Secondary outcomes (11)
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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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]).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Day 1 (survey completion visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study start22 Oct 2014
- Primary completion6 Jul 2024
- Study completion6 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54,115 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The PATH Malaria Vaccine Initiative (MVI)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251704
- Sponsor's protocol ID
- 116682
- Status last verified
- Jul 2025
- First submitted
- 25 Sep 2014
- Last updated
- 24 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: 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.