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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00784784
Recruitment Status : Completed
First Posted : November 4, 2008
Results First Posted : September 2, 2011
Last Update Posted : November 21, 2014
Information provided by:
Mount Sinai Hospital, Canada

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Fluviral Drug: Zanamivir Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : November 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of Subjects Adhering to Long-term Zanamivir Prophylaxis [ Time Frame: 5 months ]
    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).

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00784784

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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
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Principal Investigator: Allison McGeer, MD MOUNT SINAI HOSPITAL
Additional Information:
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Responsible Party: Dr. Allison McGeer/Director, Infection Control, Mount Sinai Hospital Identifier: NCT00784784    
Other Study ID Numbers: 08-0189-A
CRT113936 ( Other Grant/Funding Number: GSK )
First Posted: November 4, 2008    Key Record Dates
Results First Posted: September 2, 2011
Last Update Posted: November 21, 2014
Last Verified: November 2014
Keywords provided by Mount Sinai Hospital, Canada:
antiviral drugs
influenza vaccines
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action