Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2008/2009

Study Overview
=================
Brief Summary
-----------------
Annual trial for registration influenza vaccine with the strain composition for season 2008/2009

Official Title
-----------------
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009, When Administered to Non-Elderly Adult and Elderly Sub

Conditions
-----------------
Seasonal Influenza

Intervention / Treatment
-----------------
* Biological: Influenza Vaccine, Formulation 2008-2009


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects eligible for enrollment into this study are male and female adults who are: ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry able to comply with all study requirements in good health as determined by: medical history physical examination clinical judgment of the investigator Exclusion Criteria: They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to: Cancer, except for localized skin cancer; Advanced congestive heart failure; Chronic obstructive pulmonary disease (COPD); Autoimmune disease (including rheumatoid arthritis); Acute or progressive hepatic disease; Acute or progressive renal disease; Severe neurological or psychiatric disorder; Severe asthma. They have history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate); They have a known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from: receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; receipt of immunostimulants; receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; suspected or known HIV infection or HIV-related disease; They have a known or suspected history of drug or alcohol abuse; They have a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject; Women who are pregnant, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days); Within the past 12 months, they have: received more than one injection of influenza vaccine Within the past 6 months, they have: had laboratory confirmed influenza disease; received influenza vaccine; Within the past 4 weeks they have received: another vaccine; any investigational agent; They have any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days; 1 - They have experienced an acute exacerbation of a COPD within the past 14 days

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Biological: Influenza Vaccine, Formulation 2008-2009<br>* 1 dose of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) test on Day 0 and on Day 21 |  | 21 days (-1/+5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of safety |  | 21 days (-1/+5) | 

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