Status:
COMPLETED
Safety and Immunogenicity of Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 in Non-Elderly Adult and Elderly Subjects
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Produ...
Eligibility Criteria
Inclusion
- Healthy adults aged \>18 years
Exclusion
- serious chronic diseases or significant acute infections requiring systemic antibiotic treatment
- history of any anaphylaxis, serious vaccine reactions
- hypersensitivity against vaccine components
- history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- known or suspected impairment/alteration of immune function
- more than one injection of influenza vaccine received or laboratory confirmed influenza disease
- within last 6 months: influenza vaccination received
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00354016
Start Date
July 1 2006
Last Update
March 13 2007
Active Locations (2)
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1
Werksarztzentrum Herborn, Westerwaldstr 36,
Herborn, Germany, 35745
2
Betriebsarztlicher Dienst, Universitat Marburg, Robert-Koch-Str, 5,
Marburg, Germany, 35037