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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 October 2017 |
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Main ID: |
NCT00412737 |
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Date of registration:
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15/12/2006 |
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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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A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants
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Scientific title:
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A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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477 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00412737 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Belgium
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Canada
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Czech Republic
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Estonia
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France
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Germany
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Hungary
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Israel
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Italy
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Lithuania
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Poland
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Negative rapid diagnostic test for influenza at baseline;
- Immunocompromised participant (liver and/or kidney recipient or allogenic
hematopoietic stem cell transplant).
Exclusion Criteria:
- Symptoms suggestive of influenza-like illness; but not limited to fever, cough, or
nasal congestion;
- Influenza vaccination in 6 weeks prior to randomization;
- Positive rapid diagnostic test for influenza;
- Solid organ transplant within 6 months of randomization;
- Antiviral treatment for influenza in 2 weeks prior to randomization.
Age minimum:
1 Year
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Influenza
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Intervention(s)
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Drug: Oseltamivir
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Drug: Placebo
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Primary Outcome(s)
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Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population
[Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)]
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Secondary Outcome(s)
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Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population
[Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)]
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Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population
[Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)]
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Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population
[Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)]
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Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population
[Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)]
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Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population
[Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)]
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Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population
[Time Frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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