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)
Overview
- Phase
- Phase 3
- Intervention
- Fluviral
- Conditions
- Influenza
- Sponsor
- Mount Sinai Hospital, Canada
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Number of Laboratory Confirmed Influenza Infections
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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 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.
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Influenza vaccine
Influenza vaccine, using Fluviral trivalent split virus vaccine
Intervention: Fluviral
Antiviral prophylaxis
Zanamivir antiviral prophylaxis
Intervention: Zanamivir
Outcomes
Primary Outcomes
Number of Laboratory Confirmed Influenza Infections
Time Frame: 6 months
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)
Secondary Outcomes
- Number of Subjects Adhering to Long-term Zanamivir Prophylaxis(5 months)