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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665807
• Other study ID #: SP1203
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2012
• Last updated: October 24, 2013
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: October 2013
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 868
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 69 Years

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Vaccination Site Reactions (HT)

Intervention

Biological:
• Intanza
Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere
• Vaxigrip
Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere

Locations

Country	Name	City	State
Canada	Center for Vaccinology	Halifax	Nova Scotia
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Brenda Coleman	Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Administer Influenza Vaccine (in Seconds)	Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination	Vaccination (Day 0)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No