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.

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.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: Investigational aQIVc; Biological: licensed QIVr; Biological: licensed aQIV

• Study Type: Interventional
• Enrollment (Actual): 7741
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Red Deer, Alberta, Canada, T4P1K4
      • CARe Clinic
• Denmark
  • Hvidovre, Denmark, 2650
    • Amager-Hvidovre Hospital
  • Roskilde, Denmark, 4000
    • Zealand University Hospital, Roskilde
• Estonia
  • Paide, Estonia, 72713
    • Vee Family Doctor's Center OY
  • Tallin, Estonia, 10617
    • Merelahe Family Doctors Centre
  • Tallinn, Estonia, 10117
    • OU Innomedica
  • Tallinn, Estonia, 10128
    • Center for Clinical and Basic Research
  • Tallinn, Estonia, 10617
    • Al Mare Perearstikeskus OÜ
  • Tartu, Estonia, 50106
    • Clinical Research Centre
  • Tartu, Estonia, 50411
    • Tartu University Hospital
• Germany
  • Berlin, Germany, 10629
    • emovis GmbH
  • Berlin, Germany, 10117
    • Klinische Forschung Berlin-Mitte GmbH
  • Berlin, Germany, 10787
    • Velocity Clinical Research, Berlin
  • Dresden, Germany, 01069
    • Klinische Forschung Dresden Gmbh
  • Essen, Germany, 45355
    • Studienzentrum Bocholderstrasse
  • Essen, Germany, 45355
    • Klinisches Forschungszentrum Dr. Hagemann am Hausarztzentrum am Germaniaplatz Dr.Hagemann/ Breider
  • Essen, Germany, 45359
    • UHZ Klinische Forschung
  • Hamburg, Germany, 20253
    • Klinische Forschung Hamburg GmbH
  • Hamburg, Germany, 22143
    • Velocity Clinical Research, Hamburg
  • Hannover, Germany, 30159
    • Klinische Forschung Hannover-Mitte GmbH
  • Karlsruhe, Germany, 76137
    • Klinische Forschung Karlsruhe GmbH
  • Leipzig, Germany, 04179
    • Studienzentrum FMZ Radowsky
  • Leipzig, Germany, 04177
    • Velocity Clinical Research, Leipzig
  • Mainz, Germany, 55128
    • Research Quist
  • Schwerin, Germany, 19055
    • Klinische forschung Schwerin GmbH
  • Stuttgart, Germany, 70178
    • Studienzentrum Leitz Triderm
• Pakistan
  • Karachi, Pakistan, 74800
    • The Aga Khan University
  • Lahore, Pakistan
    • Central Park Teaching Hospital
• Philippines
  • Bulacan, Philippines
    • Marilao Saint Michael Family Hospital, Inc
  • Cavite, Philippines
    • Health Index Multispecialty and Lying in Clinic
  • Cavite, Philippines
    • CARE CT Group Inc. CARE Clinical Trials
  • Cebu City, Philippines
    • Norzel Medical and Diagnostic Clinic
  • Iloilo City, Philippines
    • West Visayas State University Medical Center
  • Manila, Philippines
    • Manila Doctors Hospital
  • Manila, Philippines
    • Mary Johnston Hospital
  • Quezon City, Philippines
    • Quirino Memorial Medical Center
  • Taguig, Philippines, 1642
    • Ospital ng Makati
  • Cavite
    • Silang, Cavite, Philippines
      • Silang Specialists Medical Center
  • Davao Del Sur
    • Davao City, Davao Del Sur, Philippines
      • Davao Medical School Foundation Inc. Hospital / NEMESIO F. ANLOCOTAN III
  • Las Pinas City
    • Las Piñas, Las Pinas City, Philippines
      • Las Piñas Doctors Hospital
• United Kingdom
  • High Wycombe, United Kingdom, HP112QW
    • Velocity High Wycombe
  • London, United Kingdom, N128BU
    • Velocity North London
  • Preston, United Kingdom, PR29RB
    • Panthera Biopartners Ltd (Preston)
  • Rochdale, United Kingdom, OL114AU
    • Panthera Biopartners Ltd (Manchester)
  • Sheffield, United Kingdom, S25FX
    • Panthera Biopartners (Sheffield)
• United States
  • Arizona
    • Tempe, Arizona, United States, 85281
      • Alliance for Multispecialty Research (AMR) Phoenix
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center for Clinical Research
  • California
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research
    • Redding, California, United States, 96001
      • Paradigm Clinical Research Center, LLC
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Clinical Research Consulting, Inc.
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Clearwater, Florida, United States, 33756
      • Innovative Research of West Florida, Inc.
    • Doral, Florida, United States, 33126
      • USA and International Research Inc.
    • Edgewater, Florida, United States, 32132
      • Velocity Clinical Research, New Smyrna Beach
    • Jupiter, Florida, United States, 33458
      • Health Awareness, Inc.
    • Largo, Florida, United States, 33777
      • ARS - Lake Oconee
    • Miami Lakes, Florida, United States, 33016
      • Global Health Research center
    • Sunrise, Florida, United States, 33351
      • Precision Clinical Research
    • Tampa, Florida, United States, 33615
      • Global Health Research center
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Velocity Clinical Research- Boise
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research
    • Gurnee, Illinois, United States, 60031
      • Great Lakes Clinical Trials, LLC. Ravenswood dba Flourish Research
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Velocity Clinical Research Valparaoso
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • Velocity Clinical Research, Sioux City
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Velocity Clinical Research, Baton Rough
    • Metairie, Louisiana, United States, 70006
      • Benchmark Research
    • Monroe, Louisiana, United States, 71201
      • IMA Evaluations LLC
  • Maryland
    • Columbia, Maryland, United States, 21075
      • Centennial Medical Group, PC
    • Rockville, Maryland, United States, 20854
      • Velocity Clinical Research Rockville
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Velocity Clinical Research Gulfport
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Alliance for Multispecialty Research, LLC
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research
  • Nebraska
    • Norfolk, Nebraska, United States, 68701
      • Velocity Clinical Research, Norfolk
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research, Omaha
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Alliance for Multispecialty Research (AMR) LLC, Las Vegas
  • New York
    • Binghamton, New York, United States, 13905
      • Velocity Clinical Research, Binghamton
    • East Syracuse, New York, United States, 13057
      • Velocity Clinical Research, Syracuse
    • New York, New York, United States, 13850
      • Velocity Clinical Research, Vestal
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
    • Cincinnati, Ohio, United States, 45242
      • Velocity Clinical Research Cincinnati
    • Cleveland, Ohio, United States, 44122
      • Velocity Clinical Research, Cleveland
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research - Medford
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research-Providence
  • South Carolina
    • Gaffney, South Carolina, United States, 29340
      • Velocity Clinical Research, Gaffney
    • Spartanburg, South Carolina, United States, 29303
      • Velocity Clinical Research, Spartanburg
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • AMR-Knoxville
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates, Inc.
  • Texas
    • Dallas, Texas, United States, 75251
      • Cedar Health Research, LLC
    • Fort Worth, Texas, United States, 76135
      • Benchmark Research
    • Houston, Texas, United States, 77065
      • DM Clinical Research - Martin Diagnostic Clinic
    • Plano, Texas, United States, 75024
      • ACRC trials Parent HQ
    • Tomball, Texas, United States, 77375
      • DM Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • BBCR Holdings LLC dba JBR Clinical Research - Midvale Campus
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research, Salt Lake City
  • Virginia
    • Suffolk, Virginia, United States, 23435
      • Velocity Clinical Research, Suffolk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Main Inclusion Criteria:

• Individuals, aged 50 years and older, who are healthy or have stable comorbidities that increase their risk of complications from influenza infection
• Individuals who can comply with all study procedures

Main Exclusion Criteria:

• Progressive, unstable, or uncontrolled clinical conditions
• Known hypersensitivity or allergy to any study vaccine component
• Known history of Guillain-Barré syndrome or other demyelinating disease
• Condition representing a contraindication to vaccination or blood draw
• Abnormal function of immune system due to known disorder or medication.
• Influenza vaccination within 180 days prior to informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational aQIVc group	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.
Active Comparator: licensed QIVr group	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.
Active Comparator: licensed aQIV group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity Endpoint: Humoral immune responses of 3 lots of aQIVc compared in pairs in terms of Day 29 GMT ratio between each pair among the 3 lots, from antibody titers measured via HI assay.	HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains.	Day 29
Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIVr and aQIV vaccines in terms of Day 29 GMT and GMT ratio of antibodies measured via HI assay.	HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains. Noninferiority of aQIVc versus comparator (QIVr or aQIV) will be demonstrated if the lower limit (LL) of the 2-sided 97.5% CI for the Day 29 GMT ratio (aQIVc/comparator) is ≥0.67 for each of the 4 vaccine strains.	Day 29
Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIVr and aQIV vaccines in terms of Day 1 to Day 29 SCR and SCR difference, from antibody titers measured via HI assay.	HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains. SCR is the percentage of subjects with seroconversion (defined as either a prevaccination [Day 1] titer <1:10 and a postvaccination [Day 29] titer ≥1:40, or a prevaccination titer ≥1:10 and a ≥4-fold increase in postvaccination titer). Noninferiority of aQIVc versus comparator (QIVr or aQIV) will be demonstrated if the lower limit (LL) of the 2-sided 97.5% CI for the difference in SCR (aQIVc minus comparator) is ≥-10% for each of the 4 vaccine strains.	Day 1 and Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with aQIV vaccine in terms of Day 29 SCR and SCR difference, GMT and GMT ratio of antibodies measured via HI assay in subjects 65 years and older.	HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains. Noninferiority will be demonstrated if the LL of the 2-sided adjusted CI for the Day 29 GMT ratio (aQIVc/comparator) is ≥0.67 for each of the 4 vaccine strains, and the LL of the 2-sided adjusted CI for the difference in SCR (aQIVc minus comparator) is ≥-10% for each of the 4 vaccine strains.	Day 1 and Day 29
Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIVr and aQIV vaccines in terms of Day 29 GMT and GMT ratio of antibodies measured via HI assay.	HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains. Superiority of aQIVc versus comparator (QIVr and aQIV) will be demonstrated if the LL of the 2-sided 97.5% CI for the inter-group GMT ratio (aQIVc/comparator) is >1.0 for each of the 4 vaccine strains.	Day 29
Immunogenicity Endpoints: For aQIVc, QIVr, and aQIV vaccines, Day 29 GMT, Day 1 to Day 29 GMFI, Percentage of subjects with HI titer ≥1:40 at Day 29, Day 1 to Day 29 SCR, SCR differences and GMT ratio of antibodies measured via HI assay.	HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains, overall and by age subgroup.	Day 1 and Day 29
Immunogenicity Endpoints: For aQIVc and aQIV vaccines, Day 29 GMT, Day 1 to Day 29 GMFI, Percentage of subjects with HI titer ≥1:40 at Day 29, Day 1 to Day 29 SCR, SCR differences, and GMT ratio of antibodies measured via HI assay.	HI assay will be measured using egg-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains in the HI-egg subset of 2750 subjects, overall and by age subgroup.	Day 1 and Day 29
Immunogenicity Endpoints: For aQIVc, QIVr and aQIV vaccines, GMT, GMFI, Percentage of subjects with HI titer ≥1:40, SCR, SCR differences, and GMT ratio of antibodies measured via HI assay.	HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains in the long-term subset of 770 subjects, overall and by age subgroup.	Day 1 up to Day 365
Immunogenicity Endpoints: For aQIVc, QIVr and aQIV vaccines, GMT, GMFI, SCR, SCR difference, and GMT ratio of antibodies measured via MN assay.	MN assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains in the long-term subset of 770 subjects, overall and by age subgroup.	Day 1 up to Day 365
Safety endpoints: For aQIVc, QIVr and aQIV vaccines, the percentages of Subjects with Solicited Local Adverse Events, Solicited Systemic Adverse Events, and Severe Solicited Local and/or Systemic AEs.		Day 1 to Day 7
Safety endpoints: For aQIVc, QIVr and aQIV vaccines, the percentage of Subjects with Unsolicited Adverse Events.		Day 1 to Day 29
Safety endpoints: For aQIVc, QIVr and aQIV vaccines, the percentages of subjects with Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and non-serious Medically Attended Adverse Events (MAAEs).		Day 1 to Day 181
Safety endpoints: For aQIVc, QIVr and aQIV vaccines, the percentages of subjects with Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and non-serious Medically Attended Adverse Events (MAAEs).	Long-term safety for the long-term subset of 770 subjects	Day 1 to Day 365

Collaborators and Investigators

• Sponsor: Seqirus
• Investigators: Study Director: Clinical Program Director, Seqirus

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2023
• Primary Completion (Actual): March 5, 2024
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: vaccine; influenza; Adjuvant; MF59
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: V201_03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the Common Technical Document (CTD) modules submitted to regulatory agencies for public release.

Summary results disclosure is either in document form (e.g., International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry [EU CTR])).

• IPD Sharing Time Frame: SEQIRUS discloses results from clinical studies within 12 months of last patient last visit (LPLV) unless otherwise mandated by local laws or regulations.
• IPD Sharing Access Criteria: SEQIRUS will consider requests from qualified scientific and medical researchers to disclose protocols, anonymized subject-level data and study-level data when there is medical, scientific and/or public health interest to ensure the safe use of a Seqirus product licensed on or after 1 January 2014 in the United States (US) and/or the European Union (EU). This applies to Seqirus-sponsored interventional studies initiated after 27 September 2007 and ongoing as of 26 December 2007, that have been included as part of a US or EU submission package which received approval in US and EU on or after 1 January 2014 and have been accepted for publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No