At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity and Safety of Two Dosages of the Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in the Elderly Compared With Standard Fluzone® in Adults and Elderly Subjects.
In Brief
A Phase 2 clinical trial evaluating Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1), Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2), and 2 other interventions for Influenza and Myxovirus Infection. Completed, enrolled 2,098 participants across 29 sites.
Detailed Summary
The present formulations are being developed for further study in the elderly population in order to generate additional supporting data. Primary Objective: To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV) compared to that of the standard Fluzone® in elderly subjects. Secondary Objectives: Immunogenicity To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®. Safety: To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.
Study Details
Timeline
Interventions
0.1 mL, Intradermal (ID)
0.1 mL, Intradermal (ID)
0.5 mL, Intramuscular (IM)
0.5 mL, Intramuscular (IM)
0.5 mL, Intramuscular (IM)