A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2009/2010 Influenza Virus Strains for the Northern Hemisphere

Study Overview
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Brief Summary
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This study is to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V fulfills the EMEA 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 2009/2010-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) 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 to ≤60 years or >60 years on Day 1 Written informed consent 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 study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed) Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity) 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 or spouse of the investigator Suspected non-compliance

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elderly<br>Elderly subjects aged over 60 years | Biological: Inflexal V<br>* Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose: 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus 15 µg HA antigen of B/Brisbane/60/2008-like virus Dose: intramuscular administration (M. deltoides) of a single dose of 0.5 mL on Day 1<br>|
| Experimental: Adults<br>Adults from 18 to 60 years old inclusive | Biological: Inflexal V<br>* Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose: 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus 15 µg HA antigen of B/Brisbane/60/2008-like virus Dose: intramuscular administration (M. deltoides) of a single dose of 0.5 mL on Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion | Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40 | Day 22 ± 2 days | 
| Seroprotection | Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40 | Day 22 ± 2 days | 
| Fold Increase in Geometric Mean Titer (GMT) | GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value | Day 22/Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Numbers of Subjects Reporting Solicited Local Adverse Events | Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination | Days 1 to 4 inclusive, and Day 22 | 
| Numbers of Subjects Reporting Solicited Systemic Adverse Events | Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination | Days 1 to 4 inclusive, and Day 22 | 

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