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

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ClinicalTrials.gov Identifier: NCT01665807
Recruitment Status : Completed
First Posted : August 15, 2012
Results First Posted : October 1, 2013
Last Update Posted : April 19, 2017
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Brenda Coleman, Mount Sinai Hospital, Canada

Study Description
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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.

Condition or disease Intervention/treatment Phase
Influenza Vaccination Site Reactions (HT) Biological: Intanza Biological: Vaxigrip Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 868 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 Start Date : September 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665807


Locations
Canada, Nova Scotia
Center for Vaccinology
Halifax, Nova Scotia, Canada
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Brenda Coleman
Sanofi Pasteur, a Sanofi Company
Investigators
Principal Investigator: Brenda L Coleman, PhD Mount Sinai Hospital, New York
Study Director: Melissa Barton Mount Sinai Hospital, New York
Study Director: Christine Moore Mount Sinai Hospital, New York
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, New York
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Brenda Coleman, Clinical Scientist, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT01665807     History of Changes
Other Study ID Numbers: SP1203
First Posted: August 15, 2012    Key Record Dates
Results First Posted: October 1, 2013
Last Update Posted: April 19, 2017
Last Verified: March 2017

Keywords provided by Brenda Coleman, Mount Sinai Hospital, Canada:
influenza
vaccine
administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
 Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs