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Completed

NCT Number: NCT02251704

Epidemiology Study of Malaria Transmission Intensity 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.

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Key information

Age range

6 month–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Nouna, Burkina Faso

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assessment of body temperature

Diagnostic Test

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

blood sampling

Procedure

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

Primary outcomes

  1. Number of Participants Infected With Plasmodium Falciparum (P. Falciparum) by World Health Organisation (WHO) Age Group

    Time frame: At Day 1 (survey completion visit)

    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.

  2. Number of Participants Infected With P. Falciparum by Joint Technical Expert Group (JTEG) Age Group

    Time frame: At Day 1 (survey completion visit)

    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.

  3. Number of Participants Using Malaria Control Interventions: Bednet Usage and Type of Bednet

    Time frame: At Day 1 (survey completion visit)

    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).

  4. Number of Participants Using Malaria Control Interventions: Mosquito Coils, Insecticide Sprays, Commercial Repellants, Traditional Repellants and Indoor Residual Sprays

    Time frame: At Day 1 (survey completion visit)

    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]).

Secondary outcomes

  1. Number of Participants Infected With P. Falciparum by Center, Gender and Infection Status

    Time frame: At Day 1 (survey completion visit)

    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).

  2. Number of Participants Infected With Plasmodium Species Other Than P. Falciparum

    Time frame: At Day 1 (survey completion visit)

    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.

  3. 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

    Time frame: At Day 1 (survey completion visit)

  4. Number of Participants Who Received Anti-malarial Therapy or Any Other Medication Within 14 Days Prior to the Study Visit

    Time frame: Up to 14 days prior to the study visit at Day 1

    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.

  5. Number of Participants With Measured Fever at the Time of Their Study Visit

    Time frame: At Day 1 (survey completion visit)

    Fever was defined as an axillary temperature of 37.5°C or higher.

  6. Number of Participants With Reported Fever in the 24 Hours Prior to Their Study Visit

    Time frame: Up to 24 hours prior to their study visit at Day 1

    Fever was defined as an axillary temperature of 37.5°C or higher.

  7. Number of Participants Demonstrating Care-seeking Behavior Following Reported Fever or Malaria up to 14 Days Prior to Their Study Visit

    Time frame: Up to 14 days prior to their study visit at Day 1

    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]).

  8. Number of Participants in Each Geo-referenced Segment

    Time frame: At Day 1 (survey completion visit)

    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.

  9. Number of Participants Experiencing Malaria Risk Factors Categorized by the Number of Participants Living in the Same House (by Parasite Density)

    Time frame: At Day 1 (survey completion visit)

    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.

  10. Number of Participants Experiencing Malaria Risk Categorized by Location (by Parasite Density)

    Time frame: At Day 1 (survey completion visit)

    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.

  11. Number of Participants Experiencing Malaria Risk Factors Categorized by House Information (by Parasite Density)

    Time frame: At Day 1 (survey completion visit)

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • The PATH Malaria Vaccine Initiative (MVI)

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2014
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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