Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

• Register: ClinicalTrials.gov
• Last refreshed on: 4 March 2024
• Main ID: NCT02251704
• Date of registration: 25/09/2014
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
• Scientific title: Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
• Date of first enrolment: October 22, 2014
• Target sample size: 54000
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02251704
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Burkina Faso, Ghana, Kenya, Malawi, Senegal, Tanzania

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

• Name: US GSK Clinical Trials Call Center

Key inclusion & exclusion criteria

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.



Age minimum: 6 Months
Age maximum: 9 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malaria Vaccines

Malaria

Intervention(s)

Diagnostic Test: Assessment of body temperature

Procedure: Blood sampling

Primary Outcome(s)

Number of subjects using malaria control interventions [Time Frame: From Day 0 to Year 10]

Number of subjects infected with P. falciparum parasitaemia (using microscopy) [Time Frame: From Day 0 to Year 10]

Secondary Outcome(s)

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]

Number of subjects using anti-malarial therapy in the 14 days prior to the visit [Time Frame: From Day 0 to Year 10]

Number of subjects by demography and medical history characteristics [Time Frame: From Day 0 to Year 10]

Number of subjects demonstrating care seeking behaviour [Time Frame: 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]

Number of subjects experiencing risk factors [Time Frame: From Day 0 to Year 10]

Number of subjects in each geo-referenced segment [Time Frame: From Day 0 to Year 10]

Number of subjects with measured fever at the visit [Time Frame: 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]

Secondary ID(s)

116682

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The PATH Malaria Vaccine Initiative (MVI)