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

Overview

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

Full Title of Study: “A Randomized Controlled Trial To Compare The Immunogenicity Of Self-Administered And Nurse-Administered Intradermal Influenza Vaccine”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 2011

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.

Interventions

  • Biological: Intanza
    • 0.1 mL of Intanza intradermally at visit # 1
  • Biological: Intanza
    • 0.1 mL of Intanza intradermally at visit #1

Arms, Groups and Cohorts

  • Active Comparator: Intanza – self-administered
    • Self-administered intradermal influenza vaccine
  • Active Comparator: Intanza – nurse-administered
    • Nurse-administered intradermal influenza vaccine

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Dalhousie University
  • Collaborator
    • IWK Health Centre
  • Provider of Information About this Clinical Study
    • Shelly McNeil, Canadian Center for Vaccinology
  • Overall Official(s)
    • Shelly McNeil, MD, Principal Investigator, Canadian Center for Vaccinology

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