NCT06015282

The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older

A Phase 3, Randomized, Observer-Blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of a MF59-Adjuvanted Quadrivalent Subunit Cell-derived Influenza Vaccine (aQIVc) in Comparison With Quadrivalent Influenza Vaccines, in Adults Aged 50 Years and Older.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7,741 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 3, randomized, parallel-group, comparator-controlled, observer-blind, multicenter study of immunogenicity and safety in approximately 7700 male and female adults aged 50 years and older (approximately equally split between two age groups: 50-64 years; 65 years and older), who are healthy or have stable comorbidities that increase their risk of complications from influenza infection. Three lots of aQIVc will be evaluated for consistency and pooled for the comparison with the 2 control vaccines. Subjects will be randomly assigned to receive 1 of 3 lots of aQIVc, QIVr, or aQIV in a 1:1:1:2:2 ratio (for a 3:2:2 ratio for aQIVc, QIVr, and aQIV). The study will have a treatment period (Day 1 to Day 29) and a follow-up period (Day 30 up to Day 181); a subset of 770 subjects will be followed up up to Day 365.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	Investigational aQIVc	Investigational 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	licensed QIVr	Recombinant Quadrivalent Influenza Vaccine (Flublok Quadrivalent/Supemtek) 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	licensed aQIV	Adjuvanted, egg-derived Quadrivalent Influenza Vaccine (Fluad) 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: 2023-11-03
• Primary completion: 2024-03-05
• Completion: 2025-01-30
• First posted: 2023-08-29
• Last updated: 2025-04-27

Locations

96 sites across 8 countries: United States, Canada, Denmark, Estonia, Germany, Pakistan, Philippines, United Kingdom

Regulatory

• FDA-regulated drug study