Status:
WITHDRAWN
Annual Study to Investigate Inactivated Virosomal Influenza Vaccine for the 2006/2007 Influenza Season in Europe.
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are...
Eligibility Criteria
Inclusion
- Signed and dated informed consent.
- Healthy and aged \>= 18 and \<= 60 years or \>= 61 years of age.
- Mental health good enough to understand the study and the informed consent form and to fill in the questionnaire."
Exclusion
- Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
- Having fever and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways.
- Having experienced a documented serious systemic reaction after previous influenza vaccination.
- Having an auto-immune disorder (e.g. RA, SLE, auto-immune thyroid disorders) or other disorders affecting the immune system, taking immunosuppressive medication (such as systemic corticosteroids) including the four weeks preceding the start of the study (date of informed consent), or having a disease in a terminal stage.
- Having received vaccination against influenza within the previous six months before Visit 1.
- Exclusion criteria only for female subjects aged \>=18 and \<=60 years and of childbearing potential:
- Pregnancy (positive urine pregnancy test on Day 1) or breastfeeding.
- Absence of use of a medically accepted method of birth control (i.e. oral contraceptive, Intra Uterine Device, double barrier method).
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00345462
Start Date
June 1 2006
Last Update
February 8 2010
Active Locations (1)
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1
Site 1
Berlin, Germany