InfluenzaPhase 4NCT01665807
A Time-motion Study Comparing Self- to Nurse-vaccination With Influenza Vaccine
A Phase 4 study testing Intanza and Vaxigrip in people with Influenza and Vaccination Site Reactions (HT), run by Brenda Coleman at 2 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Vaccination Site Reactions (HT)
- What is being tested?
- Intanza and Vaxigrip
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 868 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2012to Dec 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Center for Vaccinology
Halifax, Nova Scotia
Mount Sinai Hospital
Toronto, Ontario, M5G1X5
About this study
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
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.
Read the 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.
- Conditions
- Influenza, Vaccination Site Reactions (HT)
- Being tested
- Intanza, Vaxigrip
- Keywords
- influenza, vaccine, administration
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntanzaBiological
Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere
VaxigripBiological
Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere
| Study group | Role | What they receive |
|---|---|---|
| Nurse-administered IM | Experimental | Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL) Receives: Biological: Vaxigrip |
| Self-administered intradermal | Experimental | Self-administered intradermal influenza vaccine (Intanza 0.1 mL) Receives: Biological: Intanza |
| Repeat self-administration intradermal | Active comparator | Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study Receives: Biological: Intanza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Administer Influenza Vaccine (in Seconds)
Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination
Measured: Vaccination (Day 0)
Secondary outcomes (4)
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.
Measured: Follow up (Day 8)
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.
Measured: Vaccination (Day 0)
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
Measured: Follow up (Day 8)
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)
Measured: Follow up (Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 868 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brenda Coleman
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Responsible party
- Sponsor-investigator, Brenda Coleman, Mount Sinai Hospital, Canada
- Investigators
- Brenda L Coleman, PhD, Principal investigator, MOUNT SINAI HOSPITALMelissa Barton, Study director, MOUNT SINAI HOSPITALChristine Moore, Study director, MOUNT SINAI HOSPITALShelly A McNeil, MD, Principal investigator, Canadian Centre for VaccinologyJoanne M Langley, MD, Study director, Canadian Centre for VaccinologyScott A Halperin, MD, Study director, Canadian Centre for VaccinologyAllison J McGeer, MD, FRCPC, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665807
- Sponsor's protocol ID
- SP1203
- Status last verified
- Mar 2017
- First submitted
- 13 Aug 2012
- Last updated
- 19 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Coleman BL, McNeil SA, Langley JM, Halperin SA, McGeer AJ. Differences in efficiency, satisfaction and adverse events between self-administered intradermal and nurse-administered intramuscular influenza vaccines in hospital workers. Vaccine. 2015 Nov 27;33(48):6635-40. doi: 10.1016/j.vaccine.2015.10.095. Epub 2015 Oct 31.
PubMed 26529074
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01665807
- Acronym / sponsor ID
- SP1203
- Conditions
- Influenza, Vaccination Site Reactions (HT)
- Keywords
- influenza, vaccine, administration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 868 participants (actual)
- Lead sponsor
- Brenda ColemanUniversity, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Aug 2012 (estimated)
- Results
- Posted 1 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nurse-administered IM | Experimental | Biological: VaxigripNurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL) |
| Self-administered intradermal | Experimental | Biological: IntanzaSelf-administered intradermal influenza vaccine (Intanza 0.1 mL) |
| Repeat self-administration intradermal | Active comparator | Biological: IntanzaSelf-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IntanzaIntanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere | Biological | Repeat self-administration intradermal, Self-administered intradermal |
| VaxigripInfluenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere | Biological | Nurse-administered IM |
Primary outcome
Time to Administer Influenza Vaccine (in Seconds)
Time frame: Vaccination (Day 0)
Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination
4 secondary outcomes
Acceptability of Vaccine
Time frame: Follow up (Day 8)
Success Rate
Time frame: Vaccination (Day 0)
Local & Systemic Reactogenicity
Time frame: Follow up (Day 8)
Pain at Injection Site
Time frame: Follow up (Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26529074Coleman BL, McNeil SA, Langley JM, Halperin SA, McGeer AJ. Differences in efficiency, satisfaction and adverse events between self-administered intradermal and nurse-administered intramuscular influenza vaccines in hospital workers. Vaccine. 2015 Nov 27;33(48):6635-40. doi: 10.1016/j.vaccine.2015.10.095. Epub 2015 Oct 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenda L Coleman, PhD principal investigator
MOUNT SINAI HOSPITAL
Melissa Barton study director
MOUNT SINAI HOSPITAL
Christine Moore study director
MOUNT SINAI HOSPITAL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intanza and Vaxigrip in people with Influenza and Vaccination Site Reactions (HT), run by Brenda Coleman at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Administer Influenza Vaccine (in Seconds) (time frame: Vaccination (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01665807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.