At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Lot Consistency, Immunogenicity and Safety Study of Three Lots of Fluzone High Dose Vaccine Compared With One Lot of Standard Fluzone® in Adults ≥ 65 Years of Age.
In Brief
A Phase 3 clinical trial evaluating High-Dose Inactivated, Split-Virion Influenza Vaccine and Inactivated, Split-Virion Influenza Vaccine for Orthomyxoviridae Infection and 2 related conditions. Completed, enrolled 3,851 participants across 28 sites.
Detailed Summary
Compared to young adults, the elderly mount a lower antibody response to vaccination. Thus, improvement of the immune response to influenza vaccination in this age group, which is at higher risk for influenza-related morbidity and mortality, represents an important unmet need. Primary Objectives: Immunogenicity: * To demonstrate lot consistency of the Fluzone High Dose (Fluzone HD) manufacturing process through evaluation of the immune responses elicited by three different lots. * To demonstrate the superiority of Fluzone HD vaccine compared to standard-dose Fluzone® vaccine. Secondary Objectives: Immunogenicity: * To describe the seroprotection of Fluzone HD compared to that of standard dose Fluzone® vaccine. Safety: * To describe the safety profile of Fluzone HD, in terms of solicited -, unsolicited adverse and serious adverse events post-vaccination. * To describe clinical information on some additional defined criteria during the six months following vaccination.
Study Details
Timeline
Interventions
0.5 mL, IM
0.5 mL, IM
0.5 mL, IM
0.5 mL, IM