Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Malaria

Treatments: Other: Data collection; Procedure: Capillary blood sample

Study type: Interventional

Funder types: Industry

Identifiers

NCT01954264

200187

Details and patient eligibility

About

This study is designed to characterise P. falciparum transmission intensity in subjects aged ≥6 months and <10 years by measurement of P. falciparum parasite prevalence, and to estimate the use of malaria control interventions at some centres selected for the EPI-MAL-002 and EPI-MAL-003 studies in sub-Saharan Western Africa.

Full description

Two subsequent studies (EPI-MAL-002 and EPI-MAL-003) are planned to monitor vaccine safety prior to and after implementation of the RTS,S/AS01 candidate malaria vaccine. EPI-MAL-002 will take place before RTS,S is authorised and EPI-MAL-003 will start when RTS,S is registered and authorised in the country. A cross-sectional survey at peak transmission will provide by-site point estimates of Parasite prevalence (PP) and malaria control measure coverage in the areas participating in EPI-MAL-002/-003. EPI-MAL-006 will be conducted in advance of EPI-MAL-002/-003 in order to assess PP and malaria control measures to inform enrollment in these studies. The age group for enrollment (≥6 months - <10 years) will permit analysis of PP according to the World Health Organization (WHO) definition (2-9 years) and by the Joint Technical Expert Group (JTEG) suggested age (<5 years).

Enrollment: 2,421 patients

Sex: All

Ages: 6 months to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• A male or female equal or more than 6 months of age and less than 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,421 participants in 1 patient group

Overall Study Group

Other group

Description:

Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy.

Treatment:

Procedure: Capillary blood sample

Other: Data collection