Zanamivir Versus Trivalent Split Virus Influenza Vaccine (Stop-Flu-2)

Mount Sinai Hospital, Canada

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Drug: Zanamivir

Biological: Fluviral

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00784784

CRT113936 (Other Grant/Funding Number)

08-0189-A

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

18 to 69 years old

Volunteers

Accepts Healthy Volunteers

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)