Safety and Immunogenicity of Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 in Non-Elderly Adult and Elderly Subjects
Phase 3
Completed
- Conditions
- Influenza
- Registration Number
- NCT00354016
- Lead Sponsor
- Novartis
- 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 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
Inclusion Criteria
- Healthy adults aged >18 years
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Exclusion Criteria
- 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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21
- Secondary Outcome Measures
Name Time Method safety of a single IM dose of the split influenza vaccine using solicited local and systemic reactions and adverse event reporting
Trial Locations
- Locations (2)
Betriebsarztlicher Dienst, Universitat Marburg, Robert-Koch-Str, 5,
🇩🇪Marburg, Germany
Werksarztzentrum Herborn, Westerwaldstr 36,
🇩🇪Herborn, Germany