NCT01964989

Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.

A Phase III, Stratified, Randomized, Observer Blind, Controlled, Multicenter Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to < 72 Months of Age.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10,644 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 6 Months – 71 Months
• Healthy volunteers: Accepted

Summary

Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to \<72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.

Conditions

• Influenza Virus

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)	1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months
BIOLOGICAL	Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)	1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-10-01
• Completion: 2016-08-01
• First posted: 2013-10-17
• Last updated: 2023-03-27
• Results posted: 2023-03-27

Locations

167 sites across 11 countries: United States, Canada, Finland, Italy, Mexico, Philippines, Poland, Puerto Rico, Spain, Taiwan, Thailand