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.
1 other identifier
interventional
7,741
8 countries
96
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2023
Shorter than P25 for phase_3
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2023
CompletedFirst Posted
Study publicly available on registry
August 29, 2023
CompletedStudy Start
First participant enrolled
November 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2025
CompletedApril 27, 2025
April 1, 2025
4 months
August 23, 2023
April 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (10)
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.
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.
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.
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.
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.
Day 1 up to Day 365
- +5 more secondary outcomes
Study Arms (3)
Investigational aQIVc group
EXPERIMENTALlicensed QIVr group
ACTIVE COMPARATORlicensed aQIV group
ACTIVE COMPARATORInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seqiruslead
Study Sites (96)
Alliance for Multispecialty Research (AMR) Phoenix
Tempe, Arizona, 85281, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
Marvel Clinical Research
Huntington Beach, California, 92647, United States
Paradigm Clinical Research Center, LLC
Redding, California, 96001, United States
Clinical Research Consulting, Inc.
Milford, Connecticut, 06460, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
USA and International Research Inc.
Doral, Florida, 33126, United States
Velocity Clinical Research, New Smyrna Beach
Edgewater, Florida, 32132, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
ARS - Lake Oconee
Largo, Florida, 33777, United States
Global Health Research Center
Miami Lakes, Florida, 33016, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
Global Health Research center
Tampa, Florida, 33615, United States
Velocity Clinical Research- Boise
Meridian, Idaho, 83642, United States
Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research
Chicago, Illinois, 60640, United States
Great Lakes Clinical Trials, LLC. Ravenswood dba Flourish Research
Gurnee, Illinois, 60031, United States
Velocity Clinical Research Valparaoso
Valparaiso, Indiana, 46383, United States
Velocity Clinical Research, Sioux City
Sioux City, Iowa, 51106, United States
Velocity Clinical Research, Baton Rough
Baton Rouge, Louisiana, 70809, United States
Benchmark Research
Metairie, Louisiana, 70006, United States
IMA Evaluations LLC
Monroe, Louisiana, 71201, United States
Centennial Medical Group, PC
Columbia, Maryland, 21075, United States
Velocity Clinical Research Rockville
Rockville, Maryland, 20854, United States
Velocity Clinical Research Gulfport
Gulfport, Mississippi, 39503, United States
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, 64114, United States
Sundance Clinical Research
St Louis, Missouri, 63141, United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, 68701, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134, United States
Alliance for Multispecialty Research (AMR) LLC, Las Vegas
Las Vegas, Nevada, 89119, United States
Velocity Clinical Research, Binghamton
Binghamton, New York, 13905, United States
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057, United States
Velocity Clinical Research, Vestal
New York, New York, 13850, United States
M3 Wake Research, Inc
Raleigh, North Carolina, 27612, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Velocity Clinical Research Cincinnati
Cincinnati, Ohio, 45242, United States
Velocity Clinical Research, Cleveland
Cleveland, Ohio, 44122, United States
Velocity Clinical Research - Medford
Medford, Oregon, 97504, United States
Velocity Clinical Research-Providence
East Greenwich, Rhode Island, 02818, United States
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, 29340, United States
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina, 29303, United States
AMR-Knoxville
Knoxville, Tennessee, 37909, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203, United States
Cedar Health Research, LLC
Dallas, Texas, 75251, United States
Benchmark Research
Fort Worth, Texas, 76135, United States
DM Clinical Research - Martin Diagnostic Clinic
Houston, Texas, 77065, United States
ACRC trials Parent HQ
Plano, Texas, 75024, United States
DM Clinical Research
Tomball, Texas, 77375, United States
BBCR Holdings LLC dba JBR Clinical Research - Midvale Campus
Salt Lake City, Utah, 84107, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088, United States
Velocity Clinical Research, Suffolk
Suffolk, Virginia, 23435, United States
CARe Clinic
Red Deer, Alberta, T4P1K4, Canada
Amager-Hvidovre Hospital
Hvidovre, 2650, Denmark
Zealand University Hospital, Roskilde
Roskilde, 4000, Denmark
Vee Family Doctor's Center OY
Paide, 72713, Estonia
OÜ Innomedica
Tallinn, 10117, Estonia
Center for Clinical and Basic Research
Tallinn, 10128, Estonia
Al Mare Perearstikeskus OÜ
Tallinn, 10617, Estonia
Merelahe Family Doctors Centre
Tallinn, 10617, Estonia
Clinical Research Centre
Tartu, 50106, Estonia
Tartu University Hospital
Tartu, 50411, Estonia
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117, Germany
emovis GmbH
Berlin, 10629, Germany
Velocity Clinical Research, Berlin
Berlin, 10787, Germany
Klinische Forschung Dresden GmbH
Dresden, 01069, Germany
Klinisches Forschungszentrum Dr. Hagemann am Hausarztzentrum am Germaniaplatz Dr.Hagemann/ Breider
Essen, 45355, Germany
Studienzentrum Bocholderstrasse
Essen, 45355, Germany
UHZ Klinische Forschung
Essen, 45359, Germany
Klinische Forschung Hamburg GmbH
Hamburg, 20253, Germany
Velocity Clinical Research, Hamburg
Hamburg, 22143, Germany
Klinische Forschung Hannover-Mitte GmbH
Hanover, 30159, Germany
Klinische Forschung Karlsruhe GmbH
Karlsruhe, 76137, Germany
Velocity Clinical Research, Leipzig
Leipzig, 04177, Germany
Studienzentrum FMZ Radowsky
Leipzig, 04179, Germany
Research Quist
Mainz, 55128, Germany
Klinische Forschung Schwerin GmbH
Schwerin, 19055, Germany
Studienzentrum Leitz Triderm
Stuttgart, 70178, Germany
The Aga Khan University
Karachi, 74800, Pakistan
Central Park Teaching Hospital
Lahore, Pakistan
Silang Specialists Medical Center
Silang, Cavite, Philippines
Davao Medical School Foundation Inc. Hospital / NEMESIO F. ANLOCOTAN III
Davao City, Davao Del Sur, Philippines
Las Pinas Doctors Hospital
Las Piñas, Las Pinas City, Philippines
Marilao Saint Michael Family Hospital, Inc
Bulacan, Philippines
CARE CT Group Inc. CARE Clinical Trials
Cavite, Philippines
Health Index Multispecialty and Lying in Clinic
Cavite, Philippines
Norzel Medical and Diagnostic Clinic
Cebu City, Philippines
Ospital ng Makati
City of Taguig, 1642, Philippines
West Visayas State University Medical Center
Iloilo City, Philippines
Manila Doctors Hospital
Manila, Philippines
Mary Johnston Hospital
Manila, Philippines
Quirino Memorial Medical Center
Quezon City, Philippines
Velocity High Wycombe
High Wycombe, HP112QW, United Kingdom
Velocity North London
London, N128BU, United Kingdom
Panthera Biopartners Ltd (Preston)
Preston, PR29RB, United Kingdom
Panthera Biopartners Ltd (Manchester)
Rochdale, OL114AU, United Kingdom
Panthera Biopartners (Sheffield)
Sheffield, S25FX, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Program Director
Seqirus
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2023
First Posted
August 29, 2023
Study Start
November 3, 2023
Primary Completion
March 5, 2024
Study Completion
January 30, 2025
Last Updated
April 27, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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 \[EU CTR\])).