Influenza

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, 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 Information
96 Sites
7741 Participants
COMPLETED
50 Years

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

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov