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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00784784
First received: November 3, 2008
Last updated: August 2, 2011
Last verified: August 2011
  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)

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784784

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
GlaxoSmithKline
Investigators
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
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases
Antiviral Agents
Zanamivir
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014