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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01224613
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : June 15, 2011
Sponsor:
Collaborators:
IWK Health Centre
MCM Vaccines B.V.
Mount Sinai Hospital, Canada
Information provided by:
Dalhousie University

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

Condition or disease Intervention/treatment Phase
Influenza Biological: Intanza Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial To Compare The Immunogenicity Of Self-Administered And Nurse-Administered Intradermal Influenza Vaccine
Study Start Date : November 2010
Primary Completion Date : January 2011
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Intanza - self-administered
Self-administered intradermal influenza vaccine
Biological: Intanza
0.1 mL of Intanza intradermally at visit # 1
Other Name: Influenza Vaccine (Split Virion, Inactivated)
Active Comparator: Intanza - nurse-administered
Nurse-administered intradermal influenza vaccine
Biological: Intanza
0.1 mL of Intanza intradermally at visit #1
Other Name: Influenza Vaccine (Split Virion, Inactivated)



Primary Outcome Measures :
  1. Immunogenicity [ Time Frame: 21 days post-vaccination ]
    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).


Secondary Outcome Measures :
  1. Reactogenicity [ Time Frame: 7 days post-vaccination ]
    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.

  2. Observational [ Time Frame: at vaccination ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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)

Information from the National Library of Medicine

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): NCT01224613


Locations
Canada, Nova Scotia
Canadian Center for Vaccinology
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5K 1X5
Sponsors and Collaborators
Dalhousie University
IWK Health Centre
MCM Vaccines B.V.
Mount Sinai Hospital, Canada
Investigators
Principal Investigator: Shelly McNeil, MD Canadian Center for Vaccinology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shelly McNeil, Canadian Center for Vaccinology
ClinicalTrials.gov Identifier: NCT01224613     History of Changes
Other Study ID Numbers: SP1002
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs