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

Study Overview
=================
Brief Summary
-----------------
To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009 formulation. To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.

Official Title
-----------------
Immunogenicity and Safety Among Adults of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is 18 years of age or older on the day of inclusion. Participant willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study. Participant in reasonably good health as assessed by the Investigator. Participant willing and able to give informed consent. For a woman, inability to bear a child or negative serum/urine pregnancy test. 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 in the 72 hours preceding enrollment in the trial. Clinically significant findings in vital signs (including temperature ≥ 99.5°F oral) or review of systems. Self-reported history of severe adverse event to any influenza vaccine. Laboratory-confirmed influenza infection or 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 2. Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.* Immunocompromising condition or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 6 months. Receipt of blood or blood products within the 3 months preceding enrollment in the study. Diabetes mellitus requiring pharmacological control. Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine. Person deprived of freedom by an administrative or court order (having legal or medical guardian). For women of childbearing potential, 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. Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial procedures. Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. Prior personal history of Guillain-Barré syndrome. * Subjects enrolled into this study will not be prohibited from donating blood for non-interventional studies.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Participants received one dose of Fluzone® vaccine on Day 0. | Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)<br>* 0.5 mL, intramuscular<br>* Other names: Fluzone®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering | Days 0-3 post-vaccination | 
| Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation |  | Day 0 and 21 days post-vaccination | 
| Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection) | Seroprotection was defined as post-vaccination titer value of ≥ 1:40. | 21 days post-vaccination | 
| Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion) | Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is < 10, then 10 is used as the baseline value for the purposes of this calculation | 21 days post-vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza