NCT00959049

A Study 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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,474 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	CSL's Influenza Virus Vaccine (Afluria)	0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
BIOLOGICAL	Influenza Virus Vaccine (Fluzone)	0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-12-01
• Completion: 2010-05-01
• First posted: 2009-08-14
• Last updated: 2017-05-16
• Results posted: 2011-07-29

Locations

23 sites across 1 country: United States