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

Phase 4

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Elderly	Inflexal V	Elderly subjects aged over 60 years
Adults	Inflexal V	Adults from 18 to 60 years old inclusive

Primary Outcome Measures

Name	Time	Method
Seroconversion	Day 22 ± 2 days	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
Seroprotection	Day 22 ± 2 days	Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40
Fold Increase in Geometric Mean Titer (GMT)	Day 22/Day 1	GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value

Secondary Outcome Measures

Name	Time	Method
Safety: Numbers of Subjects Reporting Solicited Local Adverse Events	Days 1 to 4 inclusive, and Day 22	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
Numbers of Subjects Reporting Solicited Systemic Adverse Events	Days 1 to 4 inclusive, and Day 22	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