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

Epidemiology study of malaria transmission intensity in sub-Saharan Africa

GSK study ID
116682
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2024-06-07
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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
DAKAR, Senegal, 16556
Status
Study Complete
Location
GSK Investigational Site
Dakar, Senegal, 12500
Status
Study Complete
Location
GSK Investigational Site
Kintampo, Ghana, N/A
Status
Study Complete
Location
GSK Investigational Site
Navrongo, Ghana, N/A
Status
Study Complete
Location
GSK Investigational Site
Amani, Tanzania, N/A
Status
Study Complete
Location
GSK Investigational Site
Mangochi, Malawi, N/A
Status
Study Complete
Location
GSK Investigational Site
Kisumu, Kenya, 40100
Status
Study Complete
Location
GSK Investigational Site
Nairobi, Kenya, 40100
Status
Study Complete
Location
GSK Investigational Site
Chikwawa, Malawi, N/A
Status
Study Complete
Location
GSK Investigational Site
Nouna, Burkina Faso, N/A
Status
Study Complete
Location
GSK Investigational Site
Ouagadougou, Burkina Faso, 2208
Status
Study Complete

Study documents

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

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

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
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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