Influenza Clinical Trial
Official title:
Phase III Vaccination Study for Evaluation of Immunogenicity and Reactogenicity of Influsplit SSW 2004/2005 in People Age 18 or Beyond
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).
Status | Completed |
Enrollment | 120 |
Est. completion date | August 2005 |
Est. primary completion date | August 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Germany | GSK Investigational Site | Dresden | Sachsen |
Germany | GSK Investigational Site | Dresden | Sachsen |
Germany | GSK Investigational Site | Dresden | Sachsen |
Germany | GSK Investigational Site | Dresden | Sachsen |
Germany | GSK Investigational Site | Dresden | Sachsen |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Investigation of the humoral immune response (haemagglutination inhibiting antibodies) in subjects | |||
Secondary | 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. |
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