Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 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. The current study is a phase III A clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. The objective of this study is to investigate the immunogenicity and safety and tolerability of the changed influenza vaccine virus composition in two groups of subjects in good health: 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 Southern Hemisphere Season 2015. An Open-Label, Baseline-Controlled Study in Two Age Groups: Adult Subjects ≥ 18 and ≤ 60 Years and Elderly Subjects ≥ 61 Years of Age

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 (if needed) 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. Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Trivalent influenza subunit vaccine Influvac. 3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1  | 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 |
| --- | --- | --- |
| the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines. | Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults. | 3 weeks post vaccination | 
| the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines. | Mean fold increase in HI antibody titer 3 weeks After Vaccination in non-elderly adults and elderly adults. | 3 weeks post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. |  | up to 3 weeks post vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza, Vaccine, Committee for Medicinal Products for Human Use (CHMP) criteria