Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 08/09 Season.

Study Overview
=================
Brief Summary
-----------------
Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).

Official Title
-----------------
Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2008/2009. An Open-Label, Baseline-Controlled Multi-Center Study in Two Groups: Adult Subjects and Elderly Subjects

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

Intervention / Treatment
-----------------
* Biological: Trivalent influenza subunit vaccine Influvac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to give informed consent and able to adhere to all protocol required study procedures. Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator. Exclusion Criteria: Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine. A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator. Having received vaccination against influenza within the previous six months before study vaccination or planned vaccination during the study period. A history of Guillain-Barré syndrome or active neurological disease.

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 |
| --- | --- |
| Experimental: 1<br> | Biological: Trivalent influenza subunit vaccine Influvac<br>* 3x 15mcg HA per 0.5 ml, trivalent one injection at Day 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2008/2009 |  | 2 and 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP) |  | 2 and 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza, Vaccine, CHMP criteria