Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults

Study Overview
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Brief Summary
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To describe any degree of preference for the route of administration of Fluzone influenza vaccine, ID versus IM, in healthy adult subjects 18-49 years of age. To collect safety data, injection site reactions, and systemic reactions, through Day 7 post-vaccination; SAEs through day 28 post-vaccination

Detailed Description
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The purpose of this clinical trial is to determine, in a relatively small sample of persons 18-49 years of age, if there is a preference trend for a particular route of administration, ID vs IM, when receiving a seasonal influenza vaccine. Uptake of influenza vaccine is disappointingly low in this age group, and there is the perception that aversion to IM injection plays a role in vaccination avoidance. The BD Micro-Injection System to be used in this study may offer a more acceptable alternative to the standard IM injection for influenza immunization and thereby promote wider acceptance of influenza vaccination.

Official Title
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Preference for Fluzone Vaccine Administered Intradermally Versus Intramuscularly in Healthy Adult Subjects 18-49 Years of Age

Conditions
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Influenza

Intervention / Treatment
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* Biological: Fluzone: Influenza virus vaccine
* Biological: Fluzone: Influenza virus vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female subject (can have underlying medical condition, as long as they are stable), greater than or equal to 18 to < 50 years of age on the day of inclusion. Informed consent form signed. Able to attend both scheduled visits and to comply with all trial procedures. For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination. Exclusion Criteria: Subject currently breast-feeding. Participation in another investigational clinical trial in the 4 weeks preceding and during the trial period. Hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances. Thrombocytopenia or bleeding disorder contraindicating IM vaccination. Any other condition which in the opinion of the Investigator would pose a health risk to the subject or interfere with the evaluation of the vaccine. Personal history of Guillain-Barre syndrome. Current use of alcohol or recreational drugs that in the opinion of the Investigator might interfere with the subject's ability to comply with trial procedures. Febrile illness (oral temperature greater than or equal to 99.5 degrees F) on day of inclusion (temporary deferral). Influenza vaccination received this season (2007-2008).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluzone Intradermal First, Then Fluzone Intramuscular<br> | Biological: Fluzone: Influenza virus vaccine<br>* 0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid<br>* Other names: Fluzone®;|
| Experimental: Fluzone Intramuscular First, Then Fluzone Intradermal<br> | Biological: Fluzone: Influenza virus vaccine<br>* 0.5 mL, Intramuscular Right deltoid, 0.1 mL, Intradermal Left deltoid<br>* Other names: Fluzone®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Pain or other discomfort was assessed on a scale of 0 to 10 (None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; Unbearable = 9, 10) according to route of administration: intradermal (ID) as Group 1 and intramuscular (IM) as Group 2. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population. | Day 0 and up to 7 days post-vaccination | 
| Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Numerical scores were assigned to pain by participants on the preference questionnaire as: None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; or Unbearable = 9, 10. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population. | Days 0, 3, and 7 after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Influenza virus