NCT05501561

Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age

A Phase 2b, Randomized, Observer-Blind, Antigen and Adjuvant Dose-Confirmation Clinical Study to Evaluate Safety and Immunogenicity of Different Formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Cell-derived Influenza Vaccine (aQIVc) in Older Adults ≥50 Years of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,056 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

This Phase 2, randomized, observer-blind, dose-confirmation Clinical study is evaluating different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 1000 subjects are to be randomized into 1 of 4 possible treatment groups with 250 participants per group. Every participant will receive an influenza vaccine injection on Day 1 and will be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serology data.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	Experimental: IIV-A Investigational IIV-A will be administered as a single dose intramuscularly on Day 1	Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
BIOLOGICAL	Experimental: aIIV-B Investigational aIIV-B will be administered as a single dose intramuscularly on Day 1	Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
BIOLOGICAL	Experimental: aIIV-C Investigational aIIV-C will be administered as a single dose intramuscularly on Day 1	Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
BIOLOGICAL	Active Comparator: Licensed IIV IIV will be administered as a single dose intramuscularly on Day 1	Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.

Timeline

• Start date: 2022-08-25
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2022-08-15
• Last updated: 2024-04-03

Locations

47 sites across 1 country: United States

Regulatory

• FDA-regulated drug study