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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Fluviral
Zanamivir
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring antiviral drugs, influenza vaccines

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Influenza vaccine

Antiviral prophylaxis

Arm Description

Influenza vaccine, using Fluviral trivalent split virus vaccine

Zanamivir antiviral prophylaxis

Outcomes

Primary Outcome Measures

Number of Laboratory Confirmed Influenza Infections
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
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).

Full Information

First Posted
November 3, 2008
Last Updated
November 7, 2014
Sponsor
Mount Sinai Hospital, Canada
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00784784
Brief Title
Zanamivir Versus Trivalent Split Virus Influenza Vaccine
Acronym
Stop-Flu-2
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 Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mount Sinai Hospital, Canada
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
antiviral drugs, influenza vaccines

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Influenza vaccine
Arm Type
Experimental
Arm Description
Influenza vaccine, using Fluviral trivalent split virus vaccine
Arm Title
Antiviral prophylaxis
Arm Type
Experimental
Arm Description
Zanamivir antiviral prophylaxis
Intervention Type
Biological
Intervention Name(s)
Fluviral
Intervention Description
One dose
Intervention Type
Drug
Intervention Name(s)
Zanamivir
Other Intervention Name(s)
Relenza
Intervention Description
10 mg, OD, for duration of influenza season (10-23 weeks)
Primary Outcome Measure Information:
Title
Number of Laboratory Confirmed Influenza Infections
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Subjects Adhering to Long-term Zanamivir Prophylaxis
Description
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).
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison McGeer, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://microbiology.mtsinai.on.ca/research/HCW-Flu-Study/default.asp
Description
Mount Sinai Hospital

Learn more about this trial

Zanamivir Versus Trivalent Split Virus Influenza Vaccine

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