Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

February 22, 2024 updated by: GlaxoSmithKline
This epidemiology study is planned to run in parallel with the EPI-MAL-002 and EPI-MAL-003 studies, enrolling from the same health and demographic surveillance system (HDSS) (or equivalent system) populations. The co-primary objectives are to produce longitudinal estimates of parasite prevalence in humans, and record malaria control measures usage in areas where EPI-MAL-002 and EPI-MAL-003 studies will take place.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will involve up to 10 annual cross sectional surveys during malaria peak transmission with possible further extension, dependent on the duration of the EPI-MAL-002 and EPI-MAL-003 studies. Surveys will provide point estimates of parasite prevalence and subsequently a longitudinal assessment of the level of endemicity in each area covered by EPI-MAL-002 and EPI-MAL-003. This study will be conducted in parallel to EPI-MAL-002 and EPI-MAL-003 in order 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 will enable a more complete assessment of the benefits and risks of the vaccine introduction, and thereby more 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 assist generalisation of results to other populations.

Study Type

Interventional

Enrollment (Estimated)

54000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Burkina Faso
      • Nouna, Burkina Faso
        • Completed
        • GSK Investigational Site
      • Ouagadougou, Burkina Faso, 2208
        • Completed
        • GSK Investigational Site
  • Ghana
      • Kintampo, Ghana
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seth Owusu-Agyei
      • Navrongo, Ghana
        • Completed
        • GSK Investigational Site
  • Kenya
      • Kisumu, Kenya, 40100
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Bernhards Ogutu
        • Contact:
        • Contact:
      • Kisumu, Kenya, 40102
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Walter Otieno
        • Contact:
        • Contact:
  • Malawi
      • Blantyre 3, Malawi
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Dianne Janette Terlouw
        • Contact:
        • Contact:
      • Mangochi, Malawi
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kenneth Maleta
        • Contact:
        • Contact:
  • Senegal
      • Dakar, Senegal, 12500
        • Completed
        • GSK Investigational Site
      • Dakar, Senegal, 16556
        • Completed
        • GSK Investigational Site
  • Tanzania
      • Tanga, Tanzania
        • Completed
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 9 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Subjects' whose parent(s)/Legally Acceptable Representative(s) [LAR(s)], in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female 6 months to <10 years of age at the time of survey.
  • Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the child.

Exclusion Criteria:

  • Child in care.
  • Current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Study Group
Subjects 6 months to <10 years of age enrolled in HDSS catchment areas at the sites participating in the EPI-MAL-002 and EPI-MAL-003 studies of the candidate malaria vaccine RTS,S/AS01E in sub-Saharan Africa.
Procedure: Blood sampling
Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.
Diagnostic test: Assessment of body temperature
Axillary body temperature of all subjects recorded by a digital thermometer at the time of survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects infected with P. falciparum parasitaemia (using microscopy)
Time Frame: From Day 0 to Year 10
Infection with P. falciparum determined using a blood smear slide and determined using microscopy
From Day 0 to Year 10
Number of subjects using malaria control interventions
Time Frame: From Day 0 to Year 10
Malaria control interventions are mosquito net usage (including insecticide-treated nets [ITN] and long lasting insecticidal nets [LLIN]), indoor residual spraying (IRS), seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi), and artemisinin-based combination therapy (ACT) therapy received within the last 14 days
From Day 0 to Year 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects by demography and medical history characteristics
Time Frame: From Day 0 to Year 10
Parameters used to assess this outcome were gender, age and medical history
From Day 0 to Year 10
Number of subjects infected with Plasmodium species other than P. falciparum (using microscopy)
Time Frame: From Day 0 to Year 10
Infection with Plasmodium species other than P. falciparum determined using a blood smear slide and microscopy
From Day 0 to Year 10
Number of subjects with uptake and timing of the third dose of DTP/HepB/Hib pentavalent and the first dose of the measles EPI vaccines
Time Frame: From Day 0 to Year 10
Vaccination record of receipt of dose 3 of the DTP/HepB/Hib pentavalent and the first dose of the measles EPI vaccines
From Day 0 to Year 10
Number of subjects using anti-malarial therapy in the 14 days prior to the visit
Time Frame: From Day 0 to Year 10
Any anti-malarial therapy received in the last 14 days
From Day 0 to Year 10
Number of subjects with measured fever at the visit
Time Frame: From Day 0 to Year 10
Any measured fever at time of visit (axillary temperature greater than or equal to [≥] 37.5 degrees Celsius [°C])
From Day 0 to Year 10
Number of subjects with reported fever in the 24 hours prior to the visit
Time Frame: From Day 0 to Year 10
Any reported fever occurring in the last 24 hours
From Day 0 to Year 10
Number of subjects demonstrating care seeking behaviour
Time Frame: From Day 0 to Year 10
Visits to health providers following reported fever or malaria in the previous 14 days
From Day 0 to Year 10
Number of subjects in each geo-referenced segment
Time Frame: From Day 0 to Year 10
Positioning of the subject's residence is attributed to a segment with a unique ID from the grid referencing study area map in which the subject resides, where necessary, grouping small geographically proximate villages so that each segment has at least 10 study subjects to avoid personally identifiable information (PII), and proceeding as far as geographically appropriate
From Day 0 to Year 10
Number of subjects experiencing risk factors
Time Frame: From Day 0 to Year 10
Malaria risk factors are rural/urban area, construction material for the house, floor and roof, type of eaves (open/closed), use of electricity and water source (distance from and type)
From Day 0 to Year 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

The PATH Malaria Vaccine Initiative (MVI)

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2014

Primary Completion (Estimated)

August 5, 2024

Study Completion (Estimated)

August 5, 2024

Study Registration Dates

First Submitted

September 25, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimated)

September 29, 2014

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116682

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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