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

Primary Purpose

Influenza, Vaccination Site Reactions (HT)

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Intanza

Vaxigrip

About this trial

This is an interventional health services research trial for Influenza focused on measuring influenza, vaccine, administration

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

Center for Vaccinology
Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Nurse-administered IM

Self-administered intradermal

Repeat self-administration intradermal

Arm Description

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

Self-administered intradermal influenza vaccine (Intanza 0.1 mL)

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

Outcomes

Primary Outcome Measures

Time to Administer Influenza Vaccine (in Seconds)

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

Secondary Outcome Measures

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.

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.

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

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)

Full Information

NCT ID

NCT01665807

First Posted

August 13, 2012

Last Updated

March 22, 2017

Sponsor

Brenda Coleman

Collaborators

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT01665807

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Brenda Coleman

Collaborators

Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Vaccination Site Reactions (HT)

Keywords

influenza, vaccine, administration

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

868 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nurse-administered IM

Arm Type

Experimental

Arm Description

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

Arm Title

Self-administered intradermal

Arm Type

Experimental

Arm Description

Self-administered intradermal influenza vaccine (Intanza 0.1 mL)

Arm Title

Repeat self-administration intradermal

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Intanza

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Vaxigrip

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to Administer Influenza Vaccine (in Seconds)

Description

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

Time Frame

Vaccination (Day 0)

Secondary Outcome Measure Information:

Title

Acceptability of Vaccine

Description

Time Frame

Follow up (Day 8)

Title

Success Rate

Description

Time Frame

Vaccination (Day 0)

Title

Local & Systemic Reactogenicity

Description

Time Frame

Follow up (Day 8)

Title

Pain at Injection Site

Description

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)

Time Frame

Follow up (Day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials: