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

Purpose

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	Intervention	Phase
Influenza Vaccination Site Reactions (HT)	Biological: Intanza Biological: Vaxigrip	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:

Time to administer influenza vaccine [ Time Frame: Vaccination (Day 0) ] [ Designated as safety issue: No ]
Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination

Secondary Outcome Measures:

Acceptability of vaccine [ Time Frame: Follow up (Day 8) ] [ Designated as safety issue: No ]
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.
Success rate [ Time Frame: Vaccination (Day 0) ] [ Designated as safety issue: No ]
Successful self-administration, defined as being able to self-vaccinate on the first attempt, will be calculated using the number of participants who are successful divided by the number of participants randomized to self-vaccination.
Local & systemic reactogenicity [ Time Frame: Follow up (Day 8) ] [ Designated as safety issue: No ]
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
Pain at injection site [ Time Frame: Follow up (Day 8 ] [ Designated as safety issue: No ]
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)

Estimated Enrollment:	760
Study Start Date:	September 2012
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 69 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665807

Contacts

Contact: Joanna Ou, CCRP

416-586-4800 ext 4161

jou@mtsinai.on.ca

Locations

Canada, Nova Scotia
Center for Vaccinology	Not yet recruiting
Halifax, Nova Scotia, Canada
Contact: Darlene Baxendale, BScN 902 470-8931 darlene.baxendale@iwk.nshealth.ca
Principal Investigator: Shelly A McNeil, MD
Sub-Investigator: Joanne Langley, MD
Sub-Investigator: Scott A Halperin, MD
Canada, Ontario
Mount Sinai Hospital	Recruiting
Toronto, Ontario, Canada, M5G1X5
Contact: Joanna Ou, CCRP 416-586-4800 ext 4161 jou@mtsinai.on.ca
Principal Investigator: Brenda L Coleman, PhD
Principal Investigator: Allison J McGeer, MD

Sponsors and Collaborators

Brenda Coleman

Sanofi Pasteur MSD

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

No publications provided

Responsible Party:	Brenda Coleman, Clinical Scientist, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:	NCT01665807 History of Changes
Other Study ID Numbers:	SP1203
Study First Received:	August 13, 2012
Last Updated:	September 1, 2012
Health Authority:	Canada: Health Canada

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013