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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: |
NCT01040741 |
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Date of registration:
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29/12/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Observational Safety Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine
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Scientific title:
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A Prospective Observational Study of Safety and Occurrence of Influenza-like Illness Following Administration of Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine Focetria |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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7284 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01040741 |
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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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Argentina
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Netherlands
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject's age in accordance with the approved product label of the country where the
study is conducted
- Subjects will be vaccinated with Focetria®, independently of this study.
- Subjects or parent/guardian willing to provide informed consent prior to vaccination
administration and complete all of the study, including follow-up contact
Exclusion Criteria:
• Received any prior H1N1 vaccination
Age minimum:
6 Months
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pandemic Influenza A (H1N1)
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A New Flu Virus of Swine Origin
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Intervention(s)
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Other: Non-intervention observational study
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Primary Outcome(s)
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To quantify the safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects; To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects.
[Time Frame: 6 Months]
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Secondary Outcome(s)
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To assess the occurrence of laboratory confirmed H1N1sw and influenza-like illness following vaccination with Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine.
[Time Frame: 6 months]
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Secondary ID(s)
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V111_09OB
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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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