Status:
COMPLETED
Annual Study for Fluarix Registration
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 compos...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00306943
Start Date
July 1 2005
End Date
August 1 2005
Last Update
September 21 2016
Active Locations (5)
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1
GSK Investigational Site
Dresden, Saxony, Germany, 01069
2
GSK Investigational Site
Dresden, Saxony, Germany, 01099
3
GSK Investigational Site
Dresden, Saxony, Germany, 01187
4
GSK Investigational Site
Dresden, Saxony, Germany, 01219