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InfluenzaPhase 4NCT01224613

Study to Compare Self-administered and Nurse-administered Intradermal Influenza Vaccine

A Phase 4 study testing Intanza in people with Influenza, run by Dalhousie University at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the immunogenicity and reactogenicity of self-administered intradermal influenza vaccine (Intanza)to nurse-administered. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Intanza
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
2 sitesCanada
Study dates
Nov 2010to Feb 2011
Phase
Phase 4
Are there results?
None posted in the registry

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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Medically stable persons between age of 18-60
  • Available during the trial period and for follow-up
  • Able to read, understand, and sign informed consent
  • Able to be contacted by telephone for follow-up of adverse events

Who cannot join

  • Use of experimental vaccines within the month prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products during the duration of the study.
  • Receipt of immunoglobulin or other blood product within 3 months prior to enrollment
  • Receipt of other licensed vaccines within the preceding 4 weeks
  • History of a severe reaction following influenza vaccination
  • Use of cytotoxic therapy or biologic modifiers in the previous 2 years.
  • Plans to receive cytotoxic therapy during the study period.
Show all 14Show fewer
  • Concurrent acute moderate to severe illness. (Vaccination will be deferred until recovery. Subjects with mild illnesses with fever ≤37.8ºC orally may be enrolled).
  • History of medical disorder associated with immunosuppression (eg. including HIV-infected individuals, transplant recipients)
  • History of chronic lung, cardiac, renal or liver disease, which has required hospitalization in the last year.
  • Receipt of any high-dose daily systemic corticosteroids (inhaled steroids are acceptable) within two weeks of study entry. High dose is defined as a dose of 20 mg of prednisone daily or its equivalent. Topical steroids are allowed.
  • Failure to give written, informed consent
  • History of febrile illness (>37.8ºC orally) within the past 72 hours (immunization may be deferred).
  • Known allergy to eggs or other components of vaccine (i.e., thimerosal)
  • History of Guillain-Barré Syndrome (GBS)

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Canadian Center for Vaccinology

    Halifax, Nova Scotia, B3K 6R8

  • Mount Sinai Hospital

    Toronto, Ontario, M5K 1X5

Other trials in Canada

About this study

Official title: A Randomized Controlled Trial To Compare The Immunogenicity Of Self-Administered And Nurse-Administered Intradermal Influenza Vaccine

The purpose of this study is to compare the immunogenicity and reactogenicity of self-administered intradermal influenza vaccine (Intanza)to nurse-administered.

Read the detailed description

Participants will be randomized at visit one to either receive self-administered or nurse-administered intradermal influenza vaccine (Intanza). A blood sample will be taken prior to vaccination and 21 days post-vaccination. Participants will record information in a memory aid for 7 days including daily temperatures, solicited, unsolicited and general reactions. They will be called on study Day 8 to collect this information. Participants will return 21-24 days later for follow-up serology and review of adverse events.

Conditions
Influenza
Being tested
Intanza
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

    Also called Influenza Vaccine (Split Virion, Inactivated)

    0.1 mL of Intanza intradermally at visit # 1

  • IntanzaBiological

    Also called Influenza Vaccine (Split Virion, Inactivated)

    0.1 mL of Intanza intradermally at visit #1

Study groups in NCT01224613
Study groupRoleWhat they receive
Intanza - self-administeredActive comparatorSelf-administered intradermal influenza vaccine
Receives: Biological: Intanza
Intanza - nurse-administeredActive comparatorNurse-administered intradermal influenza vaccine
Receives: Biological: Intanza

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunogenicity

    That the immunogenicity of self-administered intradermal 2010/11 seasonal influenza vaccine (Intanza) is non-inferior to that of nurse administered intradermal 2010/11 seasonal influenza vaccine. Specifically, that ratio of increase in geometric mean titres between day 0 and day 21 post-vaccination are greater than 2/3 (i.e. GMT (IDS)/GMT (IDN) > 0.65).

    Measured: 21 days post-vaccination

Secondary outcomes (2)

  1. Reactogenicity

    The reactogenicity of self-administered intradermal 2010/11 seasonal influenza vaccine (Intanza) is not significantly greater than that of nurse administered intradermal 2010/11 seasonal influenza vaccine.

    Measured: 7 days post-vaccination

  2. Observational

    85% or more of healthy adults can self-administer Intanza successfully; that is, they are willing to self-administer vaccine and successfully administer it, as judged by observation by a trained nurse.

    Measured: at vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionJan 2011
  4. Study completionFeb 2011

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
276 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01224613
Sponsor's protocol ID
SP1002
Status last verified
Jun 2011
First submitted
14 Oct 2010
Last updated
15 Jun 2011
Results posted
No
Data monitoring committee
No

Publications

  • Coleman BL, McGeer AJ, Halperin SA, Langley JM, Shamout Y, Taddio A, Shah V, McNeil SA. A randomized control trial comparing immunogenicity, safety, and preference for self- versus nurse-administered intradermal influenza vaccine. Vaccine. 2012 Sep 28;30(44):6287-93. doi: 10.1016/j.vaccine.2012.08.006. Epub 2012 Aug 16.

    PubMed 22902784

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intanza in people with Influenza, run by Dalhousie University 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 4 inclusion and 14 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 15 Jun 2011. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Immunogenicity (time frame: 21 days post-vaccination). 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 NCT01224613, 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 15 Jun 2011.

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