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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00735410 |
Annual trial for registration influenza vaccine with the strain composition for season 2008/2009
Condition | Intervention | Phase |
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Seasonal Influenza, Vaccine |
Biological: Seasonal Influenza Vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Multicenter, Uncontrolled, Open-Label Study to Evaluate Safety and Immunogenicity of Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2008/2009 When Administered to Adult and Elderly Subjects |
Enrollment: | 134 |
Study Start Date: | June 2008 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: Seasonal Influenza Vaccine
1 dose of Split influenza vaccine
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Cancer, except for localized skin cancer Advanced congestive heart failure Chronic obstructive pulmonary disease (COPD) Autoimmune disease (including rheumatoid arthritis) Acute or progressive hepatic disease Acute or progressive renal disease Severe neurological or psychiatric disorder Severe Asthma
another vaccine any investigational agent;
Responsible Party: | Novartis Vaccines ( Novartis ) |
Study ID Numbers: | V44P12S, 2008-000887-18 |
Study First Received: | August 13, 2008 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00735410 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Influenza vaccine Seasonal Split |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |