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First received: August 23, 2023

Clinical Trial: The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Influenza, Human

Study Type: INTERVENTIONAL


Official Title: A Phase 3, Randomized, Observer-Blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of a MF59-Adjuvanted Quadrivalent Subunit Cell-derived Influenza Vaccine (aQIVc) in

Brief Summary: This is a Phase 3, randomized, parallel-group, comparator-controlled, observer-blind, multicenter study of immunogenicity and safety in approximately 7700 male and female adults aged 50 years and older (approximately equally split between two age groups: 50-64 years; 65 years and older), who are healthy or have stable comorbidities that increase their risk of complications from influenza infection.Three lots of aQIVc will be evaluated for consistency and pooled for the comparison with the 2 control…

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