Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults

Study Overview
=================
Brief Summary
-----------------
This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route. Primary Objective: To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years. Secondary Objective: To evaluate the safety profile during the 21-day period following each vaccination in each study group

Detailed Description
-----------------
This is an open (for the administration route) and double-blind (only for the two dosages administered at year 0 by using the investigational administration route) randomized trial conducted in subjects aged 18 to 60 years. The subjects will receive three vaccine injections at 1-year interval.

Official Title
-----------------
Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Vaxigrip® in Adults

Conditions
-----------------
Influenza, Orthomyxoviridae Infection, Myxovirus Infection

Intervention / Treatment
-----------------
* Biological: Inactivated, split-virion influenza vaccine
* Biological: Inactivated, split-virion influenza vaccine
* Biological: Inactivated, split-virion influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Subject aged between 18 and 57 years (i.e., less than 60 at the last vaccination) For woman of child-bearing potential, negative urine pregnancy test at V#01 Use of effective contraception prior to and during the trial Subject available during the trial period Subject able to read and understand the informed consent form Informed consent form signed and dated by the subject prior to any protocol-required intervention (and Visit 05 and Visit 07, respectively). Exclusion Criteria : Self-reported allergy to egg proteins, chick proteins, or any of the constituents of the vaccine, in particular, neomycin, formaldehyde, and octoxinol 9 Acute febrile disease within the 72 hours preceding V#01, or axillary temperature >37.5°C the day of inclusion, prior to vaccination (>37.0°C Czech Republic) Subject with an aggravation of existing chronic illness (heart disease, respiratory disease, etc.) Vaccination against influenza within the 6 months preceding V#01 Any vaccination within the 28 days preceding V#01 or scheduled between V#01 and V#02 Breast-feeding Immunosuppressive therapy including long term systemic corticotherapy (20 mg/day of prednisolone or equivalent for >2 weeks) or cancer therapy within the month preceding V#01 or ongoing Immunoglobulin injection within the 3 months preceding V#01 Subject taking part or planned to take part in another clinical trial (3 months before and through the trial duration) Subject having received extracted pituitary hormones Subjects who participated in the GID01 study (Lithuanian centers)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 57 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Inactivated, split-virion influenza vaccine<br>* 0.1 mL, ID. 1 injection/year for 3 years<br>|
| Experimental: 2<br> | Biological: Inactivated, split-virion influenza vaccine<br>* 0.1 mL, ID. 1 injection/year for 3 years.<br>|
| Active Comparator: 3<br> | Biological: Inactivated, split-virion influenza vaccine<br>* 0.5 mL, IM. 1 injection/year for 3 years<br>* Other names: Vaxigrip®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine. |  | 21days post-vaccination | 
| To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine |  | 21 days post-vaccination and entire study duration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza, Orthomyxoviridae Infection, Inactivated, Split-virion influenza vaccine, Intradermal injection, Adults.