Zanamivir Versus Trivalent Split Virus Influenza Vaccine (Stop-Flu-2)
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Purpose
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 benefits of vaccine and antiviral prophylaxis, the risk factors for influenza infection in healthy adults, and in assessing the safety and tolerability of seasonal antiviral prophylaxis in healthcare workers.
The pilot study will be assessing the rate of infection with influenza and the rate of adherence to long-term zanamivir in 60 healthy volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Fluviral Drug: Zanamivir |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Pilot Study for a Randomized Controlled Trial to Compare Trivalent Split Virus Influenza Vaccine to Seasonal Antiviral Prophylaxis in Healthcare and Other Healthy Adults: Assessment of Zanamivir Versus Vaccine (Stop-Flu-2) |
- Number of Laboratory Confirmed Influenza Infections [ Time Frame: 6 months ] [ Designated as safety issue: No ]Four-fold increase in antibody titer 2 weeks post injection and end of study or positive laboratory test for influenza during study (polymerase chain reaction [PCR] or culture)
- Number of Subjects Adhering to Long-term Zanamivir Prophylaxis [ Time Frame: 5 months ] [ Designated as safety issue: No ]Number of subjects taking 80% or more doses per week of zanamivir (10 mg once daily), as influenza prophylaxis, for 13 weeks or longer (as measured by weekly diary and dose counts at study visits).
| Enrollment: | 64 |
| Study Start Date: | November 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Influenza vaccine
Influenza vaccine, using Fluviral trivalent split virus vaccine
|
Biological: Fluviral
One dose
|
|
Experimental: Antiviral prophylaxis
Zanamivir antiviral prophylaxis
|
Drug: Zanamivir
10 mg, OD, for duration of influenza season (10-23 weeks)
Other Name: Relenza
|
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 influenza or when taken for several weeks at the height of influenza activity in the general community. However, the longest duration of prophylaxis with neuraminidase inhibitors in two clinical trials, to date, has been six weeks.
Antiviral medication will likely have an important role in the response to the next influenza pandemic. Additionally, there may be indications for use during seasons when the major infecting strain of influenza in not one whose antigen is well covered by the vaccine.
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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)
Contacts and Locations| Canada, Ontario | |
| Mount Sinai Hospital | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Principal Investigator: | Allison McGeer, MD | Mount Sinai Hospital, New York |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Allison McGeer/Director, Infection Control, Mount Sinai Hospital |
| ClinicalTrials.gov Identifier: | NCT00784784 History of Changes |
| Other Study ID Numbers: | 08-0189-A, CRT113936 |
| Study First Received: | November 3, 2008 |
| Results First Received: | May 13, 2011 |
| Last Updated: | August 2, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Mount Sinai Hospital, Canada:
|
antiviral drugs influenza vaccines |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Antiviral Agents |
Zanamivir Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013