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| Name | Class |
|---|---|
| Sanofi Pasteur, a Sanofi Company | INDUSTRY |
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The investigators hypothesize that people working in an acute care hospital setting will be able to successfully self-administer the intradermal vaccine (Intanza) in less time than nurse-administration of the regular intramuscular influenza vaccine (Vaxigrip). The investigators also hypothesize that people administering the intradermal vaccine for the second time will take less time to successfully administer than people administering it for the first time.
Vaccination of healthcare workers has been shown to reduce mortality and morbidity in the patients they care for, as well as reducing illness and absenteeism in the healthcare workers themselves, and healthcare worker vaccination programs have been shown to be cost-effective for hospitals because of the reduced absenteeism. Although influenza vaccination programs based on nurse-administered intramuscular vaccination are effective, easy access to vaccination for hospital staff remains a challenge, in part because of large numbers of staff working evening, night and weekend shifts. In addition, in the Canadian setting, increasing the efficiency of all hospital programs is a priority. If regular recipients of seasonal vaccine became accustomed to the practice, self-administration may significantly improve the efficiency of pandemic mass vaccination campaigns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse-administered IM | Experimental | Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL) |
|
| Self-administered intradermal | Experimental | Self-administered intradermal influenza vaccine (Intanza 0.1 mL) |
|
| Repeat self-administration intradermal | Active Comparator | Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intanza | Biological | Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Administer Influenza Vaccine (in Seconds) | Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination | Vaccination (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Vaccine | The post-vaccination (Day 0) and follow-up (Day 8) questionnaires include questions on the participant's preference for intradermal or intramuscular injections and questions about their preference for administration by a healthcare provider or self-vaccination. | Follow up (Day 8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brenda L Coleman, PhD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Melissa Barton | MOUNT SINAI HOSPITAL | Study Director |
| Christine Moore | MOUNT SINAI HOSPITAL | Study Director |
| Shelly A McNeil, MD | Canadian Centre for Vaccinology | Principal Investigator |
| Joanne M Langley, MD | Canadian Centre for Vaccinology | Study Director |
| Scott A Halperin, MD | Canadian Centre for Vaccinology | Study Director |
| Allison J McGeer, MD, FRCPC | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Vaccinology | Halifax | Nova Scotia | Canada | |||
| Mount Sinai Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26529074 | Derived | Coleman BL, McNeil SA, Langley JM, Halperin SA, McGeer AJ. Differences in efficiency, satisfaction and adverse events between self-administered intradermal and nurse-administered intramuscular influenza vaccines in hospital workers. Vaccine. 2015 Nov 27;33(48):6635-40. doi: 10.1016/j.vaccine.2015.10.095. Epub 2015 Oct 31. |
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People who had self-administered intradermal influenza vaccine in past were only eligible for the "repeat" self-administration arm.
No other pre-assignment eligibility criteria.
Sites: 2 acute care hospitals in Canada Dates: September 25, 2012 to November 20, 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Nurse-administered IM | Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL) Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere |
| FG001 | Repeat Self-administration Intradermal | Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere |
| FG002 | Self-administered Intradermal | Self-administered intradermal influenza vaccine (Intanza 0.1 mL) Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nurse-administered IM | Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL) Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere |
| BG001 | Repeat Self-administered Intradermal |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Administer Influenza Vaccine (in Seconds) | Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination | Posted | Median | Full Range | seconds | Vaccination (Day 0) |
|
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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 | Nurse-administered IM | Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL) Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brenda L. Coleman, PhD, | Mount Sinai Hospital, IDERU | 416-586-4800 | 4538 | 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 |
|---|---|
| C478242 | vaxigrip |
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| Vaxigrip | Biological | Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere |
|
| Success Rate |
Successful administration, defined as being able to self-vaccinate (or for RN to provide vaccine) on the first attempt. Will be calculated using the number of participants who are successful divided by the number of participants randomized to group. |
| Vaccination (Day 0) |
| Local & Systemic Reactogenicity | Maximum self-reported diameter of redness, induration, and swelling, and maximum intensity and duration of itchiness, fever, muscle ache, joint pain, headache, fatigue, feeling unwell, and injection site pain as reported on Day 8 after vaccination | Follow up (Day 8) |
| Pain at Injection Site | Self-perceived pain of injection will be recorded on an 11-point visual analogue scale immediately following vaccination (Day 0) and at follow-up (Day 8) | Follow up (Day 8 |
| Toronto |
| Ontario |
| M5G1X5 |
| Canada |
Self-administration (2) of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere |
| BG002 | Self-administered Intradermal | Self-administered intradermal influenza vaccine (Intanza 0.1 mL) Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Self-administered Intradermal | Self-administered intradermal influenza vaccine (Intanza 0.1 mL) Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere |
|
|
| Secondary | Acceptability of Vaccine | The post-vaccination (Day 0) and follow-up (Day 8) questionnaires include questions on the participant's preference for intradermal or intramuscular injections and questions about their preference for administration by a healthcare provider or self-vaccination. | Not Posted | Follow up (Day 8) | Participants |
| Secondary | Success Rate | Successful administration, defined as being able to self-vaccinate (or for RN to provide vaccine) on the first attempt. Will be calculated using the number of participants who are successful divided by the number of participants randomized to group. | Posted | Number | participants | Vaccination (Day 0) |
|
|
|
| Secondary | Local & Systemic Reactogenicity | Maximum self-reported diameter of redness, induration, and swelling, and maximum intensity and duration of itchiness, fever, muscle ache, joint pain, headache, fatigue, feeling unwell, and injection site pain as reported on Day 8 after vaccination | Not Posted | Follow up (Day 8) | Participants |
| Secondary | Pain at Injection Site | Self-perceived pain of injection will be recorded on an 11-point visual analogue scale immediately following vaccination (Day 0) and at follow-up (Day 8) | Not Posted | Follow up (Day 8 | Participants |
| 0 |
| 409 |
| 0 |
| 409 |
| EG001 | Repeat Self-administration Intradermal | Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere | 0 | 58 | 0 | 58 |
| EG002 | Self-administered Intradermal | Self-administered intradermal influenza vaccine (Intanza 0.1 mL) Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere | 0 | 401 | 0 | 401 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |