Annual Study for Fluarix Registration

Study Overview
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Brief Summary
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A pre-requisite to the yearly licensing process of the Influenza vaccine (FluarixTM/ Influsplit SSW®) is to demonstrate in clinical studies, the immunogenicity and reactogenicity of the vaccine composed of the new strains (2005/2006).

Detailed Description
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Since 1998 it is common practice within the European Community, to grant new licensees for Influenza Vaccines including the actual strain composition, by realizing the EU Mutual Recognition Procedure The procedure foresees the clinical testing of the vaccine before approval according to the particulars in the EU-Document CPMP/BWP/214/96: Note for Guidance on Harmonization of Requirements for Influenza Vaccines of the Committee for Proprietary Medical Products (CPMP) as Sub-Organization of the European Agency for the Evaluation of Medicinal Products. Assessment of the Immunogenicity and Reactogenicity of the in its strain composition actualized, Influenza split vaccine2004/2005 (Influenza split vaccine 2005/2006) versus the criteria of the CPMP.

Official Title
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Phase III Vaccination Study for Evaluation of Immunogenicity and Reactogenicity of Influsplit SSW 2004/2005 in People Age 18 or Beyond

Conditions
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Influenza

Intervention / Treatment
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* Biological: Influsplit SSW®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return, and follow-up visits) should be enrolled in the study. All Subjects, enrolled in this study, must not been immunized against Influenza within the season 2003/2004. Written informed consent obtained from the subject must be available, after the subject has been informed in an understandable language. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature / axillary temperature <37.5°C (99.5°F). Acute clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests. Pregnancy (exclusion by safe contraception; pregnancy test at day 0. Known allergic reactions, probably caused by one or more vaccine ingredients. Drug and/or Alcohol abusers

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

| Intervention/Treatment |
| --- |
|Biological: Influsplit SSW®|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigation of the humoral immune response (haemagglutination inhibiting antibodies) in subjects |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigation of the safety and reactogenicity in subject's age 18 or elder past application of a doses of Influenza split vaccine 2005/2006 in relation to solicited and non-solicited incidents. |  |  |