Status:
COMPLETED
Zanamivir Versus Trivalent Split Virus Influenza Vaccine
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18-69 years
Phase:
PHASE3
Brief Summary
This unblinded pilot study is intended to assess the feasibility of a larger double-blind, randomized control trial. For the larger trial the investigators are interested in understanding the relative...
Detailed Description
Several studies have demonstrated that zanamivir and oseltamivir are effective in preventing influenza infection and illness when used either as prophylaxis after exposure to a household contact with ...
Eligibility Criteria
Inclusion
- 18-69 years old as of 01/Nov/2008
- have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
- available for follow-up during the study period
- if a women of child-bearing years, must meet criteria to prevent pregnancy
Exclusion
- allergy to any component of influenza vaccine or zanamivir
- previous serious adverse event associated with influenza vaccination
- receipt of influenza vaccine between 01/Mar/2008 and start of study
- previous adverse event associated with the use of antiviral medications
- expecting to be unable to take zanamivir for more than 72 hours during study period
- planning to spend more than 2 consecutive weeks outside Canada or more than 100 km from the study site during study period
- pregnant, or planning to become pregnant, during study period
- breastfeeding, or planning to breastfeed, a child under 12 months of age during study period
- receipt of immunoglobulin within six months of study entry
- immunocompromising condition or therapy that would be expected to reduce the efficacy of vaccination
- plans to receive cytotoxic or radiation therapy during study period
- history of cardiovascular or pulmonary disease that has required hospital admission within the past year
- history of asthma or other chronic respiratory disease
- participating in a trial that will result in the receipt of an investigational medication during the period that zanamivir may be taken (15/Nov/2008 to 30/Apr/2009)
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00784784
Start Date
November 1 2008
End Date
June 1 2009
Last Update
November 21 2014
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5