Safety and Immunogenicity of Adjuvanted versus High-Dose Inactivated Influenza Vaccines in Older Adults

Funded by the Centers for Disease Control & Prevention Clinical Immunization Safety Assessment (CISA), this randomized, blinded clinical trial works to assess the safety and immunogenicity of adjuvanted inactivated influenza vaccine (aIIV3) versus High-Dose inactivated influenza vaccine (IIV3-HD) in subjects aged ≥65 years. Duke University and BMC are the two study sites.
Older adults are at high risk for influenza-related morbidity and mortality due to immunosenescence (decreased immune responses with age), multi-morbidity, specific age-related diseases (e.g. congestive heart failure, chronic lung disease) and age-related changes in compensatory physiologic responses to inflammatory states. Although the incidence of influenza is usually higher in younger adults and children than older adults, 90% of influenza-related deaths occur in older adults.