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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 April 2022 |
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Main ID: |
NCT02983487 |
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Date of registration:
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17/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pertussis Immunization Programs in Low Income Countries
PERILIC |
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Scientific title:
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Pertussis Immunization Programs in Low Income Countries |
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Date of first enrolment:
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January 22, 2017 |
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Target sample size:
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3587 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02983487 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Cambodia
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Madagascar
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Togo
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Contacts
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Name:
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Nicole GUISO, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Pasteur |
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Name:
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Fabien TAIEB, MD, MSc, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Pasteur |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Cohort 1 (WP1a)
- Infants under 6 months old
- Presenting clinical signs of a whooping cough syndrome
- Written consent obtained from a parent/guardian of the child
Cohort 2 (WP1b)
- People in regular and prolonged contact (>1h per day) with the index case for at least
5 days before the signs of whooping cough occurred in the infected child, living (or
not) in the same household.
- For the adults, written consent obtained.
- For minors under 7 yo: written consent obtained from a parent/guardian.
- For minors over 7 yo: written consent obtained from parent/guardian and oral assent
obtained from the child.
Cohort 3 (WP2)
- Child aged between 3 and 15 yo
- Up to date first pertussis vaccination (vaccination booklet or official register)
- Last pertussis vaccination done more than one year before inclusion
- For minors under 7 yo: written consent obtained from parent/guardian.
- For minors over 7 yo: written consent obtained from parent/guardian and oral assent
obtained from the child.
Exclusion Criteria:
Cohort 3 (WP2)
- Pertussis vaccination done more than one year before inclusion
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bordetella Pertussis, Whooping Cough
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Intervention(s)
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Procedure: Nasopharyngeal sampling
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Procedure: Blood Sampling
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Primary Outcome(s)
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Proportion of cases tested positive for B.Pertussis given by the presence of B. pertussis DNA in the nasopharyngeal sample or by the presence of an anti-pertussis toxin IgG level >100 IU/mL in the serum.
[Time Frame: November 2018]
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Proportion of biologically confirmed cases of pertussis in patients under 6 months old admitted into hospital with clinical signs corresponding to whooping cough syndrome.
[Time Frame: November 2018]
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Proportion of cases tested positive given by the presence of an anti-pertussis toxin IgG level >100 IU/mL in the serum.
[Time Frame: November 2018]
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Secondary Outcome(s)
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Estimation of the relative risk of the disease occurring in the contact patients based on their immunization status and age groups
[Time Frame: April 2019]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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