NCT02583256

Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine in Children Previously Vaccinated in Trial V118_05 (NCT01964989)

A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to Either the Same or Alternate Type of Vaccine, Adjuvanted or Non-adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV or QIV), Administered to Subjects Previously Vaccinated in Trial V118_05 (NCT01964989)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,601 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 12 Months – 7 Years
• 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. Subjects will receive either the Same or Alternate Type of Vaccine.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted QIV (aQIV)	Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
BIOLOGICAL	Non-adjuvanted QIV	Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Timeline

• Start date: 2016-01-29
• Primary completion: 2016-11-15
• Completion: 2017-05-09
• First posted: 2015-10-22
• Last updated: 2019-04-24
• Results posted: 2019-04-24

Locations

17 sites across 3 countries: Finland, Philippines, Thailand