Malaria Clinical Trial
Official title:
Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
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.
Status | Recruiting |
Enrollment | 54000 |
Est. completion date | August 5, 2024 |
Est. primary completion date | August 5, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 9 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Burkina Faso | GSK Investigational Site | Nouna | |
Burkina Faso | GSK Investigational Site | Ouagadougou | |
Ghana | GSK Investigational Site | Kintampo | |
Ghana | GSK Investigational Site | Navrongo | |
Kenya | GSK Investigational Site | Kisumu | |
Kenya | GSK Investigational Site | Kisumu | |
Kenya | GSK Investigational Site | Kisumu | |
Malawi | GSK Investigational Site | Blantyre 3 | |
Malawi | GSK Investigational Site | Mangochi | |
Senegal | GSK Investigational Site | Dakar | |
Senegal | GSK Investigational Site | Dakar | |
Tanzania | GSK Investigational Site | Tanga |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline | The PATH Malaria Vaccine Initiative (MVI) |
Burkina Faso, Ghana, Kenya, Malawi, Senegal, Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of subjects infected with P. falciparum parasitaemia (using microscopy) | Infection with P. falciparum determined using a blood smear slide and determined using microscopy | From Day 0 to Year 10 | |
Primary | Number of subjects using malaria control interventions | 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 | Number of subjects by demography and medical history characteristics | Parameters used to assess this outcome were gender, age and medical history | From Day 0 to Year 10 | |
Secondary | Number of subjects infected with Plasmodium species other than P. falciparum (using microscopy) | Infection with Plasmodium species other than P. falciparum determined using a blood smear slide and microscopy | From Day 0 to Year 10 | |
Secondary | 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 | 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 | |
Secondary | Number of subjects using anti-malarial therapy in the 14 days prior to the visit | Any anti-malarial therapy received in the last 14 days | From Day 0 to Year 10 | |
Secondary | Number of subjects with measured fever at the visit | 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 | |
Secondary | Number of subjects with reported fever in the 24 hours prior to the visit | Any reported fever occurring in the last 24 hours | From Day 0 to Year 10 | |
Secondary | Number of subjects demonstrating care seeking behaviour | Visits to health providers following reported fever or malaria in the previous 14 days | From Day 0 to Year 10 | |
Secondary | Number of subjects in each geo-referenced segment | 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 | |
Secondary | Number of subjects experiencing risk factors | 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 |
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