A Time-motion Study Comparing Self- to Nurse-vaccination With Influenza Vaccine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Time-Motion Study to Compare Self-vaccination With Intanza® Intradermal Influenza Vaccine to Nurse-administered Vaxigrip® Intramuscular Influenza Vaccine in Small Group Settings of Health Care Workers

Conditions
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Influenza, Vaccination Site Reactions (HT)

Intervention / Treatment
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* Biological: Intanza
* Biological: Vaxigrip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medically stable men or women 18 to 69 years of age (inclusive) Work in any capacity (including physicians and midwives with admitting privileges), volunteer, or student at participating hospital Able to read, understand, and respond to questionnaires Able to read, understand, and sign an informed consent form Available for follow-up for 8 days post-vaccination Participants in Part B (repeat administration) of the study must also have participated in the previous randomized control trial of self- versus nurse-administered intradermal influenza vaccine and must have attempted to self-administer the vaccine Exclusion Criteria: Already received 2012-13 influenza vaccine History of a severe reaction following influenza vaccination Known allergy to components of study vaccines (Intanza® or Vaxigrip®) History of Guillain-Barré Syndrome (GBS) within 8 weeks following influenza vaccination Acute febrile illness (>37.9ºC orally) within the past 48 hours (participation may be deferred until recovery for these subjects)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse-administered IM<br>Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL) | Biological: Vaxigrip<br>* Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere<br>|
| Experimental: Self-administered intradermal<br>Self-administered intradermal influenza vaccine (Intanza 0.1 mL) | Biological: Intanza<br>* Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere<br>|
| Active Comparator: Repeat self-administration intradermal<br>Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study | Biological: Intanza<br>* Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza, vaccine, administration