At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Controlled, Observer-Blind, Single-Center Study to Evaluate the Consistency of Three Consecutive Lots of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs in Healthy Subjects Aged 18 to 49 Years
In Brief
A Phase 3 clinical trial evaluating Lot A of Influenza virus vaccine, Lot B of Influenza virus vaccine, and 3 other interventions for Influenza. Completed, enrolled 1,507 participants across 2 sites.
Detailed Summary
The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to show how safe and well tolerated a conventional inactivated subunit influenza vaccine, licensed in many countries outside the United States, is compared to an inactivated influenza vaccine, licensed in the United States.
Study Details
Timeline
Interventions
1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly
1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly
1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly
1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly
1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly