Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2421 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-19

Study Completion Date

2013-11-25

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Malaria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Overall Study Group

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.

Group Type OTHER

Capillary blood sample

Intervention Type PROCEDURE

Capillary blood sample (up to 200µL) for determination of PP (blood slides).

Data collection

Intervention Type OTHER

Prospective data collection at the study visit by the internet based Electronic Case Report Form (eCRF)

Interventions

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Capillary blood sample

Capillary blood sample (up to 200µL) for determination of PP (blood slides).

Intervention Type PROCEDURE

Data collection

Prospective data collection at the study visit by the internet based Electronic Case Report Form (eCRF)

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Nouna, , Burkina Faso

Site Status

GSK Investigational Site

Ouagadougou, , Burkina Faso

Site Status

GSK Investigational Site

Dakar, , Senegal

Site Status

Countries

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Burkina Faso Senegal

References

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Diallo A, Sie A, Sirima S, Sylla K, Ndiaye M, Bountogo M, Ouedraogo E, Tine R, Ndiaye A, Coulibaly B, Ouedraogo A, Faye B, Ba EH, Compaore G, Tiono A, Sokhna C, Ye M, Diarra A, Bahmanyar ER, De Boer M, Pircon JY, Usuf EA. An epidemiological study to assess Plasmodium falciparum parasite prevalence and malaria control measures in Burkina Faso and Senegal. Malar J. 2017 Feb 6;16(1):63. doi: 10.1186/s12936-017-1715-1.

Reference Type DERIVED

PMID: 28166794 (View on PubMed)

Study Documents

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