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OpenTrials
Completed

NCT Number: NCT01665807

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

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.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center for Vaccinology, Halifax, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intanza

Biological

Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere

VAXIGRIP

Biological

Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere

Primary outcomes

  1. Time to Administer Influenza Vaccine (in Seconds)

    Time frame: Vaccination (Day 0)

    Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination

Secondary outcomes

  1. Acceptability of Vaccine

    Time frame: Follow up (Day 8)

    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.

  2. Success Rate

    Time frame: Vaccination (Day 0)

    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.

  3. Local & Systemic Reactogenicity

    Time frame: Follow up (Day 8)

    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

  4. Pain at Injection Site

    Time frame: Follow up (Day 8

    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)

Sponsors and collaborators

Lead sponsor

Brenda Coleman

Other

Collaborators

  • Sanofi Pasteur, a Sanofi Company

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 15, 2012
Registry last updated
Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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