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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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19 February 2015 |
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Main ID: |
NCT01885169 |
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Date of registration:
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20/06/2013 |
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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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LAIV (Flumist®) Administration in CF Patients
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Scientific title:
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Safety of Live-attenuated Influenza Vaccine (LAIV, Flumist®) in Patients With Cystic Fibrosis (CF) |
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Date of first enrolment:
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August 2013 |
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Target sample size:
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170 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01885169 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Caroline Quach-Thanh, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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McGill University Health Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- followed in one of the participating clinics
- considered in stable condition prior to enrollment as per their physician,
Exclusion Criteria:
- allergic to eggs or other vaccine components
- patients for whom LAIV is contraindicated (i.e. on oral steroids for an acute asthma
exacerbation or with a medically-attended wheezing episode in the 7 days prior to
immunization)
- participants with clinically significant nasal polyps
- have a significant febrile illness (oral temperature = 380C) at day of vaccination
- pregnant women
- immunosuppressed subjects
Age minimum:
2 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Biological: Flumist®
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Primary Outcome(s)
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Risk of severe respiratory deterioration in the 28-day period after LAIV leading to unscheduled clinical visit or emergency department visit with or without a hospitalization, compared to the second 28-day period (D29-56).
[Time Frame: at-risk period (Days 1-28 post LAIV) and non at-risk period (Days 29-56)]
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Secondary Outcome(s)
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Efficacy in preventing viral shedding
[Time Frame: Days 1, 2, 4, and 7 after LAIV]
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Secondary ID(s)
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2012-4621
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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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