Trial Outcomes & Findings for A Time-motion Study Comparing Self- to Nurse-vaccination With Influenza Vaccine (NCT NCT01665807)
NCT ID: NCT01665807
Last Updated: 2017-04-19
Results Overview
Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
868 participants
Primary outcome timeframe
Vaccination (Day 0)
Results posted on
2017-04-19
Participant Flow
Sites: 2 acute care hospitals in Canada Dates: September 25, 2012 to November 20, 2012
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.
Participant milestones
| Measure |
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
|
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
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
411
|
58
|
402
|
|
Overall Study
COMPLETED
|
409
|
58
|
401
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere
|
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
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
Baseline Characteristics
A Time-motion Study Comparing Self- to Nurse-vaccination With Influenza Vaccine
Baseline characteristics by cohort
| Measure |
Nurse-administered IM
n=411 Participants
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
|
Repeat Self-administered Intradermal
n=58 Participants
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
|
Self-administered Intradermal
n=402 Participants
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
|
Total
n=871 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
386 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
391 Participants
n=27 Participants
|
835 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 13.2 • n=93 Participants
|
40.2 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
41.2 years
STANDARD_DEVIATION 12.6 • n=27 Participants
|
42.5 years
STANDARD_DEVIATION 12.9 • n=483 Participants
|
|
Sex/Gender, Customized
Female
|
295 participants
n=93 Participants
|
39 participants
n=4 Participants
|
282 participants
n=27 Participants
|
616 participants
n=483 Participants
|
|
Sex/Gender, Customized
Male
|
113 participants
n=93 Participants
|
19 participants
n=4 Participants
|
119 participants
n=27 Participants
|
251 participants
n=483 Participants
|
|
Region of Enrollment
Canada
|
411 participants
n=93 Participants
|
58 participants
n=4 Participants
|
402 participants
n=27 Participants
|
871 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Vaccination (Day 0)Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination
Outcome measures
| Measure |
Nurse-administered IM
n=408 Participants
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
|
Repeat Self-administration Intradermal
n=57 Participants
Self-administration 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
|
Self-administered Intradermal
n=395 Participants
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
|
|---|---|---|---|
|
Time to Administer Influenza Vaccine (in Seconds)
|
90.0 seconds
Interval 18.0 to 235.3
|
182.0 seconds
Interval 42.5 to 671.1
|
62.6 seconds
Interval 29.8 to 97.7
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Nurse-administered IM
n=409 Participants
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
|
Repeat Self-administration Intradermal
n=58 Participants
Self-administration 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
|
Self-administered Intradermal
n=401 Participants
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
|
|---|---|---|---|
|
Success Rate
|
0 participants
|
58 participants
|
394 participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Follow up (Day 8Self-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)
Outcome measures
Outcome data not reported
Adverse Events
Nurse-administered IM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Repeat Self-administration Intradermal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self-administered Intradermal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place