Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
Information source: Novartis
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Seasonal Influenza; Vaccine
Intervention: Cell-derived influenza vaccine (Biological); Egg-derived influenza vaccine (Biological)
Phase: Phase 4
Status: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Vaccines, Study Chair, Affiliation: Novartis Vaccines
Overall contact:
Novartis Vaccines Drug information services, Phone: +1 800 244 7668
Summary
Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian
Cell Culture in subjects 18 years of age and above with and without underlying medical
conditions and evaluation of the immunogenicity in a subset of subjects with underlying
medical conditions, both compared to an egg-based vaccine in a post marketing setting.
Clinical Details
Official title: A Phase IV, Multi-Center, Active-Controlled, Observer-Blind Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and to Evaluate the Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
Study design: Prevention, Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Safety Study
Primary outcome: To compare the safety of a single intramuscular (IM) dose of the cell-derived influenza subunit vaccine with that of the egg-derived influenza subunit vaccine in adult and elderly subjects with and without underlying conditions.
Secondary outcome: To evaluate the immunogenicity of both vaccines for each influenza vaccine strain, as measured by hemagglutination inhibition (HI) test 21 days after vaccination in a subset of adult and elderly subjects with underlying medical conditions.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- subjects 18 years of age and above, mentally competent, willing and able to give
informed consent prior to study entry;
- able to comply with all study procedures and requirements.
Exclusion Criteria:
- history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any
vaccine component
- fatal prognosis of an underlying medical condition (<12 months life expectancy)
- history of Guillain-Barré syndrome
- bleeding diathesis or receiving anticoagulants of the coumarin type
- hospitalization or residence in a nursing care facility
- plans to receive seasonal influenza vaccine outside of this study
- receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for
live vaccines) prior to enrollment in this study
- fever (defined as axillary temperature ³38. 0°C) or any acute illness within 3 days
prior to study vaccination
- receipt of another investigational agent within 30 days prior to enrollment
- females who are pregnant or nursing (breastfeeding) mothers
Locations and Contacts
Novartis Vaccines Drug information services, Phone: +1 800 244 7668
Duisberg, Germany; Recruiting
Novartis Vaccines, Phone: +1 800 244 7668
Novartis Vaccines, Principal Investigator
Additional Information
Starting date: November 2007
Ending date: June 2008
Last updated: November 16, 2007
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