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OpenTrials
Completed

NCT Number: NCT01224613

Study to Compare 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Canadian Center for Vaccinology, Halifax, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intanza

Biological

0.1 mL of Intanza intradermally at visit # 1

Other names: Influenza Vaccine (Split Virion, Inactivated)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dalhousie University

Other

Collaborators

  • IWK Health Centre
  • MCM Vaccines B.V.
  • Mount Sinai Hospital, Canada

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2010
Registry last updated
Jun 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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