NCT05044195

A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age

A Phase 3, Randomized, Observer-blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Comparison With a Licensed Quadrivalent Influenza Vaccine, in Adults 50 to 64 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,044 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 50 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This Phase 3 study is a randomized, observer-blind immunogenicity and safety study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of age.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	aQIV	Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
BIOLOGICAL	Comparator QIV	Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1

Timeline

• Start date: 2021-09-30
• Primary completion: 2022-01-18
• Completion: 2022-09-09
• First posted: 2021-09-14
• Last updated: 2023-09-28
• Results posted: 2023-09-28

Locations

29 sites across 3 countries: United States, Estonia, Germany

Regulatory

• FDA-regulated drug study