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

Phase 4

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Nurse-administered IM	Vaxigrip	Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)
Repeat self-administration intradermal	Intanza	Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study
Self-administered intradermal	Intanza	Self-administered intradermal influenza vaccine (Intanza 0.1 mL)

Primary Outcome Measures

Name	Time	Method
Time to Administer Influenza Vaccine (in Seconds)	Vaccination (Day 0)	Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination

Secondary Outcome Measures

Name	Time	Method
Pain at Injection Site	Follow up (Day 8	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)
Acceptability of Vaccine	Follow up (Day 8)	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.
Success Rate	Vaccination (Day 0)	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.
Local & Systemic Reactogenicity	Follow up (Day 8)	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