Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains (2013-14)

Study Overview
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Brief Summary
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The study is to assess whether the influenza vaccine Inflexal V for season 2013/2014 fulfills the EMA requirements for re-registration of influenza vaccines.

Official Title
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Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2013/2014-season Virosomal Subunit Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations

Conditions
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Influenza

Intervention / Treatment
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* Biological: Inflexal V


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female and male adults aged ≥18 on Day 1 Written informed consent Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years Exclusion Criteria: Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease Acute febrile illness (≥38.0 °C) Prior vaccination with an influenza vaccine in the past 330 days Known hypersensitivity to any vaccine component Previous history of a serious adverse reaction to influenza vaccine History of egg protein allergy or severe atopy Known blood coagulation disorder Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed) Known immunodeficiency (incl. leukemia, HIV seropositivity), cancer Investigational medicinal product received in the past 3 months (90 days) Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days) Pregnancy or lactation Participation in another clinical trial Employee at the investigational site, or relative of the investigator Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elderly subjects aged over 60 years<br> | Biological: Inflexal V<br>* Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V<br>* Other names: • 15 µg HA antigen of B/Massachusetts/2/2012-like virus;|
| Experimental: Adults from 18 to 60 years old inclusive<br> | Biological: Inflexal V<br>* Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V<br>* Other names: • 15 µg HA antigen of B/Massachusetts/2/2012-like virus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with seroconversion, seroprotection, and fold increase in geometric mean titer (GMT) | Immunogenicity variables are analyzed according to the EMA re-licensing criteria; at least one of the criteria has to be fulfilled for each vaccine strain: Seroconversion rate at Day 22 has to be >40% of subjects aged ≥18 to ≤60 years and >30% of subjects aged >60 years, or Seroprotection rate at Day 22 has to be >70% of subjects aged ≥18 to ≤60 years and >60% of subjects aged >60 years, or GMT-fold increase at Day 22 compared to baseline: a >2.5-fold increase has to be reached in subjects aged ≥18 to ≤60 years and a >2.0-fold increase has to be reached in subjects aged >60 years | Day 22 +/- 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of solicited local adverse events |  | Days 1 to 4 inclusive | 
| Incidence of solicited systemic adverse events |  | Days 1 to 4 inclusive | 
| Incidence of unsolicited adverse events |  | Days 1 to 22 inclusive | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Virus, Vaccination, Inflexal V