At a glance
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Safety and Immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age
In Brief
A Phase 2 clinical trial evaluating High-Dose Trivalent Inactivated Influenza Vaccine and Trivalent Inactivated Influenza Vaccine for Influenza. Completed, enrolled 300 participants across 5 sites.
Detailed Summary
The aim of the study is to generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age Primary Objective: * To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV. * To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as assessed by solicited adverse reactions collected for 7 days post-vaccination, and unsolicited adverse events (including Serious Adverse Events and Adverse Events of Special Interests) collected between Visit 1 and Visit 2
Study Details
Timeline
Interventions
0.5 mL Intramuscular
0.5 mL, Intramuscular