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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00354016 |
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 Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (CPMP/BWP/214/96).
Condition | Intervention | Phase |
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Influenza |
Biological: preservative free inactivated split influenza vaccine using the strain composition 2006/2007 |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Multicenter, Uncontrolled, Open-Label Study to Demonstrate Safety and Immunogenicity of a Commercially Available Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 When Administered to Non-Elderly Adult and Elderly Subjects |
Estimated Enrollment: | 125 |
Study Start Date: | July 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Werksarztzentrum Herborn, Westerwaldstr 36, | |
Herborn, Germany, 35745 | |
Betriebsarztlicher Dienst, Universitat Marburg, Robert-Koch-Str, 5, | |
Marburg, Germany, 35037 |
Study Chair: | Novartis Vaccines - Drug Information Services | Novartis Vaccines & Diagnostics |
Study ID Numbers: | V44P10S, EudraCT number 2006-000438-11 |
Study First Received: | July 18, 2006 |
Last Updated: | March 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00354016 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
influenza vaccine |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
RNA Virus Infections |