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

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza; Vaccination Site Reactions (HT)
• Intervention / Treatment: Biological: Vaxigrip; Biological: Intanza

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.

• Study Type: Interventional
• Enrollment (Actual): 868
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Center For Vaccinology
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nurse-administered IM; Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)	Biological: Vaxigrip; Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere
Experimental: Self-administered intradermal; Self-administered intradermal influenza vaccine (Intanza 0.1 mL)	Biological: Intanza; Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere
Active Comparator: 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	Biological: Intanza; Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brenda Coleman
• Collaborators: Sanofi Pasteur, a Sanofi Company
• Investigators: Principal Investigator: Brenda L Coleman, PhD, Mount Sinai Hospital; Study Director: Melissa Barton, Mount Sinai Hospital; Study Director: Christine Moore, Mount Sinai Hospital; Principal Investigator: Shelly A McNeil, MD, Canadian Centre for Vaccinology; Study Director: Joanne M Langley, MD, Canadian Centre for Vaccinology; Study Director: Scott A Halperin, MD, Canadian Centre for Vaccinology; Principal Investigator: Allison J McGeer, MD, FRCPC, Mount Sinai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 13, 2012
• First Submitted That Met QC Criteria: August 14, 2012
• First Posted (Estimate): August 15, 2012

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: March 22, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: vaccine; influenza; administration
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: SP1203