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Influenza, Human

The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older
NCT06015282 | Phase 3 | Interventional

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, QIV1, or QIV2 in a 1:1:1:2:2 ratio (for a 3:2:2 ratio for aQIVc, QIV1, and QIV2). 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 Information
67 Sites
7700 Participants
50 Years

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Alliance for Multispecialty Research (AMR) Phoenix
Tempe,Arizona,United States,85281
Baptist Health Center for Clinical Research
Little Rock,Arkansas,United States,72205
Marvel Clinical Research
Huntington Beach,California,United States,92647
Paradigm Clinical Research Center
Redding,California,United States,96001
Chase Medical Research, LLC
Waterbury,Connecticut,United States,06708
Innovative Research of West Florida
Clearwater,Florida,United States,33756
Velocity Clinical Research, New Smyrna Beach
Edgewater,Florida,United States,32132
Accel Research Sites Network, STP
Largo,Florida,United States,33777
Global Health Research Center, Inc.
Miami Lakes,Florida,United States,33016
Precision Clinical Research
Sunrise,Florida,United States,33351
Velocity Clinical Research Boise
Meridian,Idaho,United States,83642
Great Lakes Clinical Trials, a Flourish Research Site
Gurnee,Illinois,United States,60031
Velocity Clinical Research Valparaoso
Valparaiso,Indiana,United States,46383
Velocity Clinical Research, Sioux City
Sioux City,Iowa,United States,51106
Velocity Clinical Research
Baton Rouge,Louisiana,United States,70809
Benchmark Research
Metairie,Louisiana,United States,70006
IMA Clinical Research
Monroe,Louisiana,United States,71201
Centennial Medical Group
Elkridge,Maryland,United States,21075
Velocity Clinical Research
Rockville,Maryland,United States,20854
Velocity Clinical Research
Gulfport,Mississippi,United States,39503
Alliance for Multispecialty ResearchKansas City
Kansas City,Missouri,United States,64114
Sundance Clinical Research, LLC
Saint Louis,Missouri,United States,63141
Velocity Clinical Research, Omaha
Omaha,Nebraska,United States,68134
Alliance for Multispecialty Research LLC, Las Vegas
Las Vegas,Nevada,United States,89119
Velocity Clinical Research
Binghamton,New York,United States,13905
Velocity Clinical Research
New York,New York,United States,13057
Vestal, Velocity Clinical Research
New York,New York,United States,13850
M Wake Research, Inc
Raleigh,North Carolina,United States,27612
Velocity Clinical Research
Beachwood,Ohio,United States,44122
Velocity Clinical Research Medford
Medford,Oregon,United States,97504
Velocity Clinical ResearchProvidence
East Greenwich,Rhode Island,United States,02818
Velocity Clinical Research, Gaffney
Gaffney,South Carolina,United States,29340
Velocity Clinical Research, Spartanburg
Spartanburg,South Carolina,United States,29303
Knoxville,Tennessee,United States,37909
Clinical Research Associates, Inc.
Nashville,Tennessee,United States,37203
Cedar Health Research
Dallas,Texas,United States,75251
DM Clinical Research
Houston,Texas,United States,77065
ACRC trials Village Health Partners
Plano,Texas,United States,75024
DM Clinical Research
Tomball,Texas,United States,77375
JBR Clinical Research
Millcreek,Utah,United States,84107
Velocity Clinical Research
West Jordan,Utah,United States,84088
Velocity Clinical Research
Portsmouth,Virginia,United States,23703
AmagerHvidovre Hospital
Zealand University Hospital, Roskilde
Vee Family Doctor's Center OY
O Innomedica
Center for Clinical and Basic Research
Al Mare Perearstikeskus O
Merelahe Family Doctors Centre
Clinical Research Centre
Tartu University Hospital
Klinische Forschung BerlinMitte GmbH
emovis GmbH
Klinische Forschung Berlin
Klinische Forschung Dresden GmbH
Klinisches Forschungszentrum Dr. Hagemann am Hausarztzentrum am Germaniaplatz Dr.Hagemann Breider
Studienzentrum Bocholderstrasse
UHZ Klinische Forschung
Klinische Forschung Hamburg GmbH
Velocity Clinical Research, Hamburg
Klinische Forschung HannoverMitte GmbH
Klinische Forschung Karlsruhe GmbH
Velocity Clinical Research, Leipzig
Studienzentrum FMZ Radowsky
Research Quist
Klinische Forschung Schwerin GmbH
Studienzentrum Leitz Triderm

Study Eligibility 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
  • 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.

Additional Studies

Additional studies can be found at