At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
In Brief
A Phase 3 clinical trial evaluating TIVc_LOT A, TIVc_LOT B, and 2 other interventions for Prophylaxis: Influenza. Completed, enrolled 1,561 participants across 24 sites.
Detailed Summary
The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf). The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws. Female subjects of childbearing potential were tested for pregnancy before the administration of the vaccine and included only if using and agreeing to continue to use contraception during the course of the study. The total study participation time per subject is about 3 weeks.
Study Details
Timeline
Interventions
Single IM (Intramuscular) administration dose of 0.5 mL of TIVc
Single IM administration dose of 0.5 mL of TIVc
Single IM administration dose of 0.5 mL of TIVc
Single IM administration dose of 0.5 mL of TIVf