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

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 |
- Time to Administer Influenza Vaccine (in Seconds) [ Time Frame: Vaccination (Day 0) ]Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination
- 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.
- 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.
- 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
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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)

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
Canada, Nova Scotia | |
Center for Vaccinology | |
Halifax, Nova Scotia, Canada | |
Canada, Ontario | |
Mount Sinai Hospital | |
Toronto, Ontario, Canada, M5G1X5 |
Principal Investigator: | Brenda L Coleman, PhD | MOUNT SINAI HOSPITAL | |
Study Director: | Melissa Barton | MOUNT SINAI HOSPITAL | |
Study Director: | Christine Moore | MOUNT SINAI HOSPITAL | |
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 |
Responsible Party: | Brenda Coleman, Clinical Scientist, Mount Sinai Hospital, Canada |
ClinicalTrials.gov Identifier: | NCT01665807 |
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 |
influenza vaccine administration |
Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections |
RNA Virus Infections Virus Diseases Respiratory Tract Diseases |