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

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

Detailed Description
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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.

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

Conditions
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Influenza

Intervention / Treatment
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* Biological: Intanza
* Biological: Intanza


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intanza - self-administered<br>Self-administered intradermal influenza vaccine | Biological: Intanza<br>* 0.1 mL of Intanza intradermally at visit # 1<br>* Other names: Influenza Vaccine (Split Virion, Inactivated);|
| Active Comparator: Intanza - nurse-administered<br>Nurse-administered intradermal influenza vaccine | Biological: Intanza<br>* 0.1 mL of Intanza intradermally at visit #1<br>* Other names: Influenza Vaccine (Split Virion, Inactivated);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | 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). | 21 days post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactogenicity | 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. | 7 days post-vaccination | 
| Observational | 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. | at vaccination |