Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains

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 2012/2013 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 2012/2013-Season 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/Wisconsin/1/2010-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/Wisconsin/1/2010-like virus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection | Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997) | Day 22 +/- 2 days | 
| Seroconversion | Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997) | Day 22 +/- 2 days | 
| Geometric Mean Titer | GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997) | Day 22 +/- 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability | Solicited local and systemic AEs, Unsolicited AEs Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days). Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4 | Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days) | 

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