At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.
In Brief
A Phase 3 clinical trial evaluating CSL's Influenza Virus Vaccine (Afluria) and Influenza Virus Vaccine (Fluzone) for Influenza. Completed, enrolled 1,474 participants across 23 sites.
Detailed Summary
The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.
Study Details
Timeline
Interventions
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines