At a glance
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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 (Optaflu®) or in Embryonated Hen Eggs (Agrippal®) in Adults and Elderly With and Without Underlying Medical Conditions, and to Evaluate the Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
In Brief
A Phase 4 clinical trial evaluating Cell-derived influenza vaccine and Egg-derived influenza vaccine for Seasonal Influenza and Vaccine. Completed, enrolled 1,398 participants across 15 sites.
Detailed Summary
Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian Cell Culture or in embryonated Hen Eggs 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, compared to an egg-based vaccine in a post marketing setting.
Study Details
Timeline
Interventions
1 dose of 0.5 mL in the deltoid region of the non-dominant arm
1 dose of 0.5 mL in the deltoid region of the non-dominant arm