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

Brenda Coleman

Status and phase: Completed; Phase 4

Conditions: Influenza; Vaccination Site Reactions (HT)

Treatments: Biological: Vaxigrip; Biological: Intanza

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01665807

SP1203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 868 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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868 participants in 3 patient groups

Nurse-administered IM

Experimental group

Description:

Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)

Treatment:

Biological: Vaxigrip

Self-administered intradermal

Experimental group

Description:

Self-administered intradermal influenza vaccine (Intanza 0.1 mL)

Treatment:

Biological: Intanza

Repeat self-administration intradermal

Active Comparator group

Description:

Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study

Treatment:

Biological: Intanza