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| ID | Type | Description | Link |
|---|---|---|---|
| CRT113936 | Other Grant/Funding Number | GSK |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza vaccine | Experimental | Influenza vaccine, using Fluviral trivalent split virus vaccine |
|
| Antiviral prophylaxis | Experimental | Zanamivir antiviral prophylaxis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluviral | Biological | One dose |
| |
| Zanamivir |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allison McGeer, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
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Recruitment period: November 5th to November 19th, 2008 in Toronto, Ontario Canada. Most subjects were healthcare workers employed at a 470-bed acute care facility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Influenza Vaccine | Influenza vaccine, using Fluviral trivalent split virus vaccine |
| FG001 | Antiviral Prophylaxis | Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Influenza Vaccine | Influenza vaccine, using Fluviral trivalent split virus vaccine |
| BG001 | Antiviral Prophylaxis | Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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). | ITT | Posted | Number | 95% Confidence Interval | participants | 5 months |
|
7 months
Solicited and unsolicited adverse event reporting
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Influenza Vaccine | Influenza vaccine, using Fluviral trivalent split virus vaccine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Broken bone | Musculoskeletal and connective tissue disorders | MedDRA 10 | Non-systematic Assessment |
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Pilot study: Limited number of participants
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brenda Coleman | Mount Sinai Hospital | 416-586-4800 | 4161 | bcoleman@mtsinai.on.ca |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D053243 | Zanamivir |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Drug |
10 mg, OD, for duration of influenza season (10-23 weeks) |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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) | intention to treat | Posted | Number | infections | 6 months |
|
|
|
|
| 2 |
| 20 |
| 0 |
| 22 |
| EG001 | Antiviral Prophylaxis | Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis | 1 | 40 | 0 | 40 |
| pneumonia | Respiratory, thoracic and mediastinal disorders | pneumonia | Non-systematic Assessment |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D006146 |
| Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D012794 | Sialic Acids |
| D009438 | Neuraminic Acids |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |