Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine

Study Overview
=================
Brief Summary
-----------------
A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity

Official Title
-----------------
Randomized, Double-Blind Study to Assess Safety, Immunogenicity, and Lot Consistency of Solvay's Cell-Derived Influenza Vaccine and Its Non-Inferiority Compared to Influvac®.

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

Intervention / Treatment
-----------------
* Biological: Influenza Vaccine
* Biological: Influenza Vaccine
* Biological: Influenza Vaccine
* Biological: Influenza Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Female or male subjects >= 18 years of age (adults >= 18 to < =60 years of age or elderly >= 61 years of age). Willing and able to give informed consent before any protocol procedures are performed. Able to adhere to visit schedules and all protocol required study procedures. Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination). Exclusion Criteria Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22). Presence of any significant condition that may prohibit inclusion as determined by the Investigator. A serious adverse reaction after a previous (influenza) vaccination. A history of Guillain-Barré syndrome. Known to be allergic to constituents of the study vaccines.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Influenza Vaccine<br>* surface antigen, inactivated, prepared in cell cultures<br>|
| Experimental: 2<br> | Biological: Influenza Vaccine<br>* surface antigen, inactivated, prepared in cell cultures<br>|
| Experimental: 3<br> | Biological: Influenza Vaccine<br>* surface antigen, inactivated, prepared in cell cultures<br>|
| Active Comparator: 4<br> | Biological: Influenza Vaccine<br>* surface antigen, inactivated, prepared in egg (influvac ®)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase |  | 3 weeks | 

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