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

NCT01665807

CompletedPhase 4

Sponsor: Brenda Coleman

Conditions: Influenza, Vaccination Site Reactions (HT)

Interventions: Intanza, Vaxigrip

Countries: Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 69 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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)
Locations (2)
  • Halifax, Nova Scotia, Canada
  • Toronto, Ontario, Canada