The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older
NCT ID: NCT06015282
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
7741 participants
INTERVENTIONAL
2023-11-03
2025-01-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Investigational aQIVc group
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.
licensed QIVr group
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.
licensed aQIV group
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Individuals who can comply with all study procedures
Exclusion Criteria
* 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.
50 Years
ALL
Yes
Sponsors
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Seqirus
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Program Director
Role: STUDY_DIRECTOR
Seqirus
Locations
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Alliance for Multispecialty Research (AMR) Phoenix
Tempe, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Marvel Clinical Research
Huntington Beach, California, United States
Paradigm Clinical Research Center, LLC
Redding, California, United States
Clinical Research Consulting, Inc.
Milford, Connecticut, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
USA and International Research Inc.
Doral, Florida, United States
Velocity Clinical Research, New Smyrna Beach
Edgewater, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
ARS - Lake Oconee
Largo, Florida, United States
Global Health Research Center
Miami Lakes, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Global Health Research center
Tampa, Florida, United States
Velocity Clinical Research- Boise
Meridian, Idaho, United States
Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research
Chicago, Illinois, United States
Great Lakes Clinical Trials, LLC. Ravenswood dba Flourish Research
Gurnee, Illinois, United States
Velocity Clinical Research Valparaoso
Valparaiso, Indiana, United States
Velocity Clinical Research, Sioux City
Sioux City, Iowa, United States
Velocity Clinical Research, Baton Rough
Baton Rouge, Louisiana, United States
Benchmark Research
Metairie, Louisiana, United States
IMA Evaluations LLC
Monroe, Louisiana, United States
Centennial Medical Group, PC
Columbia, Maryland, United States
Velocity Clinical Research Rockville
Rockville, Maryland, United States
Velocity Clinical Research Gulfport
Gulfport, Mississippi, United States
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, United States
Sundance Clinical Research
St Louis, Missouri, United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States
Alliance for Multispecialty Research (AMR) LLC, Las Vegas
Las Vegas, Nevada, United States
Velocity Clinical Research, Binghamton
Binghamton, New York, United States
Velocity Clinical Research, Syracuse
East Syracuse, New York, United States
Velocity Clinical Research, Vestal
New York, New York, United States
M3 Wake Research, Inc
Raleigh, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Velocity Clinical Research Cincinnati
Cincinnati, Ohio, United States
Velocity Clinical Research, Cleveland
Cleveland, Ohio, United States
Velocity Clinical Research - Medford
Medford, Oregon, United States
Velocity Clinical Research-Providence
East Greenwich, Rhode Island, United States
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, United States
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina, United States
AMR-Knoxville
Knoxville, Tennessee, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Cedar Health Research, LLC
Dallas, Texas, United States
Benchmark Research
Fort Worth, Texas, United States
DM Clinical Research - Martin Diagnostic Clinic
Houston, Texas, United States
ACRC trials Parent HQ
Plano, Texas, United States
DM Clinical Research
Tomball, Texas, United States
BBCR Holdings LLC dba JBR Clinical Research - Midvale Campus
Salt Lake City, Utah, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Velocity Clinical Research, Suffolk
Suffolk, Virginia, United States
CARe Clinic
Red Deer, Alberta, Canada
Amager-Hvidovre Hospital
Hvidovre, , Denmark
Zealand University Hospital, Roskilde
Roskilde, , Denmark
Vee Family Doctor's Center OY
Paide, , Estonia
OÜ Innomedica
Tallinn, , Estonia
Center for Clinical and Basic Research
Tallinn, , Estonia
Al Mare Perearstikeskus OÜ
Tallinn, , Estonia
Merelahe Family Doctors Centre
Tallinn, , Estonia
Clinical Research Centre
Tartu, , Estonia
Tartu University Hospital
Tartu, , Estonia
Klinische Forschung Berlin-Mitte GmbH
Berlin, , Germany
emovis GmbH
Berlin, , Germany
Velocity Clinical Research, Berlin
Berlin, , Germany
Klinische Forschung Dresden GmbH
Dresden, , Germany
Klinisches Forschungszentrum Dr. Hagemann am Hausarztzentrum am Germaniaplatz Dr.Hagemann/ Breider
Essen, , Germany
Studienzentrum Bocholderstrasse
Essen, , Germany
UHZ Klinische Forschung
Essen, , Germany
Klinische Forschung Hamburg GmbH
Hamburg, , Germany
Velocity Clinical Research, Hamburg
Hamburg, , Germany
Klinische Forschung Hannover-Mitte GmbH
Hanover, , Germany
Klinische Forschung Karlsruhe GmbH
Karlsruhe, , Germany
Velocity Clinical Research, Leipzig
Leipzig, , Germany
Studienzentrum FMZ Radowsky
Leipzig, , Germany
Research Quist
Mainz, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
Studienzentrum Leitz Triderm
Stuttgart, , Germany
The Aga Khan University
Karachi, , 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, , 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, , United Kingdom
Velocity North London
London, , United Kingdom
Panthera Biopartners Ltd (Preston)
Preston, , United Kingdom
Panthera Biopartners Ltd (Manchester)
Rochdale, , United Kingdom
Panthera Biopartners (Sheffield)
Sheffield, , United Kingdom
Countries
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Other Identifiers
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V201_03
Identifier Type: -
Identifier Source: org_study_id
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