Clinical trial NCT01665807: A Time-motion Study Comparing Self- to Nurse-vaccination With Influenza Vaccine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Vaccination Site Reactions (HT)
Keywords: influenza
vaccine
administration
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Sanofi Pasteur, a Sanofi Company
First posted: 2012-08-15
Enrollment: 868
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Time to Administer Influenza Vaccine (in Seconds)
timeFrame: Vaccination (Day 0)
Secondary outcomes:
measure: Acceptability of Vaccine
timeFrame: Follow up (Day 8)
measure: Success Rate
timeFrame: Vaccination (Day 0)
measure: Local & Systemic Reactogenicity
timeFrame: Follow up (Day 8)
measure: Pain at Injection Site
timeFrame: Follow up (Day 8
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Center for Vaccinology
state: Nova Scotia
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Brenda L Coleman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MOUNT SINAI HOSPITAL
name: Melissa Barton
role: STUDY_DIRECTOR
affiliation: MOUNT SINAI HOSPITAL
name: Christine Moore
role: STUDY_DIRECTOR
affiliation: Canadian Centre for Vaccinology
name: Shelly A McNeil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Centre for Vaccinology
name: Joanne M Langley, MD
role: STUDY_DIRECTOR
affiliation: Canadian Centre for Vaccinology
name: Scott A Halperin, MD
role: STUDY_DIRECTOR
affiliation: MOUNT SINAI HOSPITAL
name: Allison J McGeer, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.