Last updated: 07/04/2025 13:20:28

Epidemiology study of malaria transmission intensity in sub-Saharan Africa

GSK study ID
116682
See study documents
Clinicaltrials.gov ID
NCT02251704
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of participants infected with Plasmodium falciparum (P. falciparum) by World Health Organisation (WHO) age group

Timeframe: At Day 1 (survey completion visit)

Number of participants infected with P. falciparum by Joint Technical Expert Group (JTEG) age group

Timeframe: At Day 1 (survey completion visit)

Number of participants using malaria control interventions: bednet usage and type of bednet

Timeframe: 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

Timeframe: At Day 1 (survey completion visit)

Secondary outcomes:

Number of participants infected with P. falciparum by center, gender and infection status

Timeframe: At Day 1 (survey completion visit)

Number of participants infected with Plasmodium species other than P. falciparum

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: At Day 1 (survey completion visit)

Number of participants with reported fever in the 24 hours prior to their study visit

Timeframe: 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

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

Number of participants in each geo-referenced segment

Timeframe: 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)

Timeframe: At Day 1 (survey completion visit)

Number of participants experiencing malaria risk categorized by location (by parasite density)

Timeframe: At Day 1 (survey completion visit)

Number of participants experiencing malaria risk factors categorized by house information (by parasite density)

Timeframe: At Day 1 (survey completion visit)

Interventions:
  • Diagnostic test: Assessment of body temperature
  • Procedure/surgery: Blood sampling
    • Enrollment:
    54115
    Primary completion date:
    2024-06-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Malaria
    Product
    SB257049
    Collaborators
    PATH-Malaria Vaccine Initiative (MVI)
    Study date(s)
    October 2014 to July 2024
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    6 Months - 9 Years
    Accepts healthy volunteers
    Yes
    • 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.
    • Child was in care.
    • Had current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    DAKAR, Senegal, 16556
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dakar, Senegal, 12500
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kintampo, Ghana, N/A
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Navrongo, Ghana, N/A
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Amani, Tanzania, N/A
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mangochi, Malawi, N/A
    Status
    Study Complete
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    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2024-06-07
    Actual study completion date
    2024-06-07

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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