NCT02212106

A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years

A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL's Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Accepted

Summary

This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)	Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
BIOLOGICAL	Comparator Quadrivalent Influenza Virus Vaccine	Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-08-08
• Last updated: 2015-10-16
• Results posted: 2015-10-16

Locations

11 sites across 1 country: United States