Influenza Clinical Trial
Official title:
Randomized, Double Blind, Controlled Phase II Trial of the Safety, Tolerability and Immunogenicity of Fluzone® Inactivated Trivalent Influenza Virus Vaccine Administered With and Without JVRS-100 Adjuvant in Subjects 65 Years and Older
This study is designed to determine the optimal dose of JVRS-100 and assess safety, tolerability and immunogenicity of Fluzone® vaccine administered with JVRS-100 adjuvant at one of three dose levels compared to Fluzone® vaccine administered alone, in 472 adults aged ≥65 years.
Approximately 472 subjects will be enrolled in this study. The study population will include
elderly male and female subjects aged ≥65 years who are living in the community (including
assisted living environments) and who are very fit to moderately frail.
One hundred subjects (approximately 25 in each treatment arms) will be vaccinated, and 14
days will elapse during which safety parameters are monitored by a Data and Safety
Monitoring Board (DSMB), before randomizing the remaining 372 subjects.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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