NCT02255409

Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05

A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), Administered to Subjects Previously Vaccinated in Trial V118_05

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 607 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 12 Months – 84 Months
• Healthy volunteers: Accepted

Summary

Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial V118\_05

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)	1 dose 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months
BIOLOGICAL	non-adjuvanted Quadrivalent Influenza Vaccine (QIV)	1 dose 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-10-02
• Last updated: 2023-03-15
• Results posted: 2023-03-15

Locations

28 sites across 2 countries: United States, Finland