Influenza, Vaccination Site Reactions (HT)
Conditions
Keywords
influenza, vaccine, administration
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.
Interventions
Sponsors
Sanofi Pasteur, a Sanofi Company
Brenda Coleman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Administer Influenza Vaccine (in Seconds) | Vaccination (Day 0) | Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Vaccine | 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. |
| Success Rate | 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. |
| Local & Systemic Reactogenicity | 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 |
| Pain at Injection Site | 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) |
Countries
Canada
Participant flow
Recruitment details
Sites: 2 acute care hospitals in Canada Dates: September 25, 2012 to November 20, 2012
Pre-assignment details
People who had self-administered intradermal influenza vaccine in past were only eligible for the repeat self-administration arm. No other pre-assignment eligibility criteria.
Participants by arm
| Arm | Count |
|---|---|
| Nurse-administered IM Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)
Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere | 411 |
| Repeat Self-administered Intradermal Self-administration (2) of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere | 58 |
| Self-administered Intradermal Self-administered intradermal influenza vaccine (Intanza 0.1 mL)
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere | 402 |
| Total | 871 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Repeat Self-administered Intradermal | Self-administered Intradermal | Nurse-administered IM | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 11 Participants | 25 Participants | 36 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 391 Participants | 386 Participants | 835 Participants |
| Age, Continuous | 40.2 years STANDARD_DEVIATION 11.3 | 41.2 years STANDARD_DEVIATION 12.6 | 44.0 years STANDARD_DEVIATION 13.2 | 42.5 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment Canada | 58 participants | 402 participants | 411 participants | 871 participants |
| Sex/Gender, Customized Female | 39 participants | 282 participants | 295 participants | 616 participants |
| Sex/Gender, Customized Male | 19 participants | 119 participants | 113 participants | 251 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 409 | 0 / 58 | 0 / 401 |
| serious Total, serious adverse events | 0 / 409 | 0 / 58 | 0 / 401 |
Outcome results
Primary
Time to Administer Influenza Vaccine (in Seconds)
Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination
Time frame: Vaccination (Day 0)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nurse-administered IM | Time to Administer Influenza Vaccine (in Seconds) | 90.0 seconds |
| Repeat Self-administration Intradermal | Time to Administer Influenza Vaccine (in Seconds) | 182.0 seconds |
| Self-administered Intradermal | Time to Administer Influenza Vaccine (in Seconds) | 62.6 seconds |
Secondary
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.
Time frame: Follow up (Day 8)
Secondary
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
Time frame: Follow up (Day 8)
Secondary
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)
Time frame: Follow up (Day 8
Secondary
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.
Time frame: Vaccination (Day 0)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nurse-administered IM | Success Rate | 0 participants |
| Repeat Self-administration Intradermal | Success Rate | 58 participants |
| Self-administered Intradermal | Success Rate | 394 participants |