NCT04576702

Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults

A Phase 2, Randomized, Stratified, Observer-Blind Clinical Study to Evaluate Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Older Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 471 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

This Phase 2, randomized, observer-blind, active controlled clinical study is evaluating the safety and immunogenicity of the investigational MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 480 subjects are to be randomized into 1 of 4 possible treatment groups (investigational Influenza Vaccine or licensed Quadrivalent Influenza Vaccine comparators) at 120 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 serum.

Conditions

• Influenza
• Human

Interventions

Type	Name	Description
BIOLOGICAL	Investigational aIIV4c	Investigational MF59 Adjuvanted Cell-derived 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	IIV4c	Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
BIOLOGICAL	aIIV4	Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
BIOLOGICAL	RIV4	Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.

Timeline

• Start date: 2020-10-08
• Primary completion: 2021-03-19
• Completion: 2021-05-24
• First posted: 2020-10-06
• Last updated: 2024-04-17
• Results posted: 2024-04-17

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study