The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older
- Conditions
- Influenza, Human
- Interventions
- Biological: Investigational aQIVcBiological: licensed QIVrBiological: licensed aQIV
- Registration Number
- NCT06015282
- Lead Sponsor
- Seqirus
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7741
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Investigational aQIVc group Investigational aQIVc - licensed QIVr group licensed QIVr - licensed aQIV group licensed aQIV -
- Primary Outcome Measures
Name Time Method 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. Day 29 HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains.
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 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.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. Day 1 and Day 29 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.
- Secondary Outcome Measures
Name Time Method 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 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.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 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.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 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.
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 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.
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 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.
Immunogenicity Endpoints: For aQIVc, QIVr and aQIV vaccines, GMT, GMFI, SCR, SCR difference, and GMT ratio of antibodies measured via MN assay. Day 1 up to Day 365 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.
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 365 Long-term safety for the long-term subset of 770 subjects
Trial Locations
- Locations (95)
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
🇺🇸Fort Worth, Texas, 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
🇺🇸Saint 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
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
🇪🇪Tallin, 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
🇩🇪Hannover, 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
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
Ospital ng Makati
🇵🇭Taguig, 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