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Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Malaria

Treatments

Other: Data collection
Procedure: Capillary blood sample

Study type

Interventional

Funder types

Industry

Identifiers

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)

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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