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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: January 2011
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.
- 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
- 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).
- 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.
- 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
- 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
- Lead Sponsor
- Dalhousie University
- 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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