Phase 3
N=64
Zanamivir Versus Trivalent Split Virus Influenza Vaccine
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00784784 ↗Enrolled (actual)
64
Serious AEs
5.0%
Results posted
Sep 2011
Primary outcome: Primary: Number of Laboratory Confirmed Influenza Infections — 2; 1 infections — p=0.25
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluviral (Biological); Zanamivir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mount Sinai Hospital, Canada
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Laboratory Confirmed Influenza Infections |
2; 1 | 0.25 |
| SECONDARY Number of Subjects Adhering to Long-term Zanamivir Prophylaxis |
34 | — |
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.
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
- 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)
Data sourced from ClinicalTrials.gov (NCT00784784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.