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Clinical Trials/NCT01545115
NCT01545115CompletedNot Applicable

Study of the Environmental Factors Modulating Children Immune Response in Northern Senegal

Biomedical Research Center EPLS1 site in 1 country410 target enrollmentStarted: October 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
410
Locations
1

Study Overview

Brief Summary

Longitudinal survey in Northern Senegal to investigate the environmental factors modulating the immune response to childhood vaccines and to malaria.

A cohort of 410 children aged 1 to 10 from 5 villages of the Senegal River Valley(Podor District) was followed-up for 18 months. During that period, 5 visits have been made to the villages to assess the immunological and nutritional status of the children.

Detailed Description

Longitudinal survey in Northern Senegal to investigate the environmental factors modulating the immune response to childhood vaccines and to malaria.

A cohort of 410 children aged 1 to 10 from 5 villages of the Senegal River Valley(Podor District) was followed-up for 18 months. During that period, 5 visits have been made to the villages to assess the immunological and nutritional status of the children (T1 (October 2008), T2 (January 2009), T3 (June 2009), T4 (October 2009) and T5 (January 2010)).

The project was approved by the National Ethics Committee of Senegal. Written individual informed consent was obtained from each participant's parent or legal guardian at the beginning of the survey, and at each visit child's and parent's approval was sought orally.

Capillary blood was collected from the finger tip of each child, using sterile single-use material.

Body temperature was measured by means of auricular thermometer at all visits. Anthropomorphic data were collected at visits T2, T3, T4 and T5.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
1 Year to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age: between 1 and 10 years

Exclusion Criteria

  • Fever (body temperature superior to 38.5 °C)

Investigators

Sponsor
Biomedical Research Center EPLS
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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