Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at three weeks post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).

Official Title
-----------------
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects

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

Intervention / Treatment
-----------------
* Biological: Influenza vaccine (split virion, inactivated)
* Biological: AdimFlu-S


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or non-pregnant females and aged ≥ 18 years; Willing and able to adhere to visit schedules and all study requirements; Subjects read and signed the study-specific informed consent. Exclusion Criteria: -

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: AdimFlu-S<br> | Biological: Influenza vaccine (split virion, inactivated)<br>* AdimFlu-S, Inactivated Influenza Vaccine Trivalent Types A and B (Split) Formulation 2012-2013 Dosage: 0.5mL/per syringe Administration route: Intramuscular Injection, once<br>* Other names: AdimFlu-S Influenza Vaccine;Biological: AdimFlu-S<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity endpoint: Seroprotection rate | Seroprotection rate is defined as the proportion of subjects with HAI titer ≥ 1:40. | At 3 weeks after vaccination | 
| Immunogenicity endpoint: Seroconversion rate | The seroconversion is defined as the HAI titer of the post-vaccination serum is at least 1:40 for those who had a negative pre-vaccination HAI serum titer or a four-fold or greater increase in HAI titers in subjects who had a positive pre-vaccination HAI serum titer. The seropositive is defined as the HAI titer ≥ 1:10, and the seronegative is defined as HAI titer < 1:10. | At 3 weeks after vaccination | 
| Immunogenicity endpoint: Geometric mean folds increase in HAI titer |  | At 3 weeks after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Reactogenicity events | Reactogenicity events are pre-specified adverse events systematically recorded for 7 days after vaccination. The selection of the events to be collected systematically is based on events expected to occur with wild-type influenza infection including fever (≥38°C), runny nose or nasal congestion, cough, sore throat, headache, muscle aches, vomiting, nausea and malaise. Furthermore, the local (injection site) reactions will also be evaluated that include soreness/pain, swelling, redness, ecchymosis and limitation of arm motion. | 7 days after vaccination | 
| Safety: Serious and non-serious adverse events |  | Through day 21 post vaccination | 

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