A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

Study Overview
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Brief Summary
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To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years. To describe the immune response at 21 days following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.

Detailed Description
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Safety will be assessed throughout the trial period. Using antigens provided by Aventis Pasteur Inc., pre- and post-vaccination serum antibody titers for each of the three vaccine strains will be measured.

Official Title
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Safety and Immunogenicity of Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004

Conditions
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Influenza

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Age of 18 years or greater. Ambulatory. In reasonably good health as assessed by the investigator. Available for duration of the study (21 days + 2d). Willing and able to meet protocol requirements. Willing and able to give informed consent. Exclusion Criteria : Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde. An acute illness with or without fever (temperature >100.4°F) in the 72 hours preceding enrollment in the trial. Clinically significant findings in vital signs (including temperature >100.4°F) or review of systems. Self-reported history of severe adverse event to any influenza vaccine. Vaccination against influenza in the 6 months preceding enrollment in the study. Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3. Participation in any other experimental drug or vaccine trial within the 30 days preceding enrollment into the study. Immunosuppressive therapy including long-term (> 2 weeks) systemic corticosteroids or cancer therapy within the past 3 months or ongoing. Receipt of blood or blood products within the 3 months preceding enrollment in the study. Diabetes Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine (e.g., existing severe chronic illness such as pulmonary disorders, cardiovascular disorders, chronic blood disorders, etc.). Person deprived of freedom by an administrative or court order (having legal or medical guardian). For women of childbearing age, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluzone® Vaccine Group 1<br>Participants aged 18 to 59 years at enrollment - Fluzone® Group | Biological: Influenza virus vaccine<br>* 0.5 mL, Intramuscular<br>* Other names: Fluzone®;|
| Experimental: Fluzone® Vaccine Group 2<br>Participants aged 60 years and older at enrollment - Fluzone® Group | Biological: Influenza virus vaccine<br>* 0.5 mL, Intramuscular<br>* Other names: Fluzone®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site. Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia | Days 0 to 3 Post-vaccination | 
| Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay. | Day 0 and Day 21 Post-vaccination | 
| Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® | Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay. | Day 21 Post-vaccination | 
| Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone® | Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay | Day 21 Post-vaccination | 

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