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

This study has been completed.
Sponsor:
Collaborators:
IWK Health Centre
Sanofi Pasteur MSD
Mount Sinai Hospital, Canada
Information provided by:
Dalhousie University
ClinicalTrials.gov Identifier:
NCT01224613
First received: October 14, 2010
Last updated: June 14, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Influenza
 Biological: Intanza
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial To Compare The Immunogenicity Of Self-Administered And Nurse-Administered Intradermal Influenza Vaccine

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Dalhousie University:

Primary Outcome Measures:
  • Immunogenicity [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: No ]
    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:
  • Reactogenicity [ Time Frame: 7 days post-vaccination ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 276
Study Start Date: November 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Sanofi Pasteur MSD
Mount Sinai Hospital, Canada
Investigators
Principal Investigator: Shelly McNeil, MD Canadian Center for Vaccinology
  More Information

No publications provided by Dalhousie University

Additional 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
Study First Received: October 14, 2010
Last Updated: June 14, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013