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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02311387
Date of registration: 05/12/2014
Prospective Registration: Yes
Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Public title: Seroprevalence and Incidence of Lassa Fever in the Rural Commune of Sibirila, District of Bougouni, Mali
Scientific title: Study of the Seroprevalence and the Incidence of Lassa Fever in the Rural Commune of Sibirila, District of Bougouni, Mali
Date of first enrolment: December 5, 2014
Target sample size: 601
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02311387
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Mali
Contacts
Name:     Heinrich U Feldmann, M.D.
Address: 
Telephone:
Email:
Affiliation:  National Institute of Allergy and Infectious Diseases (NIAID)
Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

- Age greater than or equal to 6 months.

- Resident of Soromba, Bamba or Banzana with no plans to relocate within 1 year.

EXCLUSION CRITERIA:

- Any condition that in the opinion of the investigator would render the participant
unable to comply with the protocol (e.g., psychiatric disease).

- Any health condition that would confound data analysis or pose unnecessary exposure
risks to study personnel in the opinion of the investigator.



Age minimum: 6 Months
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Lassa Virus Infection
Intervention(s)
Primary Outcome(s)
To determine the annual incidence of seroconversion due to Lassa virus infection. Prevalence of Lassa virus exposure at the start of the study will be compared to the prevalence at the end of one calendar year to determine the one year incidence... [Time Frame: One year after study start date.]
To determine the seroprevalence of Lassa virus infection in the population of Southern Mali at the study start date. The prevalence of Lassa virus infection will be based on serological evidence in the villages of Soromba, Bamba and Banzana. [Time Frame: At time of study start.]
To determine the proportion of individuals in these villages who haveexperienced symptoms consistent with Lassa fever at the start of the study [Time Frame: At time of study start.]
Secondary Outcome(s)
Secondary ID(s)
15-I-N023
999915023
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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