Clinical trial NCT06015282: The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Keywords: influenza
vaccine
MF59
Adjuvant
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2023-08-29
Enrollment: 7741
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Main Inclusion 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 Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: Day 29
measure: 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.
timeFrame: Day 29
measure: 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.
timeFrame: Day 1 and Day 29
Secondary outcomes:
measure: 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.
timeFrame: Day 1 and Day 29
measure: 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.
timeFrame: Day 29
measure: 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.
timeFrame: Day 1 and Day 29
measure: 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.
timeFrame: Day 1 and Day 29
measure: 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.
timeFrame: Day 1 up to Day 365
measure: Immunogenicity Endpoints: For aQIVc, QIVr and aQIV vaccines, GMT, GMFI, SCR, SCR difference, and GMT ratio of antibodies measured via MN assay.
timeFrame: Day 1 up to Day 365
measure: 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.
timeFrame: Day 1 to Day 7
measure: Safety endpoints: For aQIVc, QIVr and aQIV vaccines, the percentage of Subjects with Unsolicited Adverse Events.
timeFrame: Day 1 to Day 29
measure: 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).
timeFrame: Day 1 to Day 181
measure: 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).
timeFrame: Day 1 to Day 365
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Alliance for Multispecialty Research (AMR) Phoenix
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: Redding
country: United States
facility: Paradigm Clinical Research Center, LLC
state: California
city: Milford
country: United States
facility: Clinical Research Consulting, Inc.
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Doral
country: United States
facility: USA and International Research Inc.
state: Florida
city: Edgewater
country: United States
facility: Velocity Clinical Research, New Smyrna Beach
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Largo
country: United States
facility: ARS - Lake Oconee
state: Florida
city: Miami Lakes
country: United States
facility: Global Health Research Center
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Tampa
country: United States
facility: Global Health Research center
state: Florida
city: Meridian
country: United States
facility: Velocity Clinical Research- Boise
state: Idaho
city: Chicago
country: United States
facility: Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research
state: Illinois
city: Gurnee
country: United States
facility: Great Lakes Clinical Trials, LLC. Ravenswood dba Flourish Research
state: Illinois
city: Valparaiso
country: United States
facility: Velocity Clinical Research Valparaoso
state: Indiana
city: Sioux City
country: United States
facility: Velocity Clinical Research, Sioux City
state: Iowa
city: Baton Rouge
country: United States
facility: Velocity Clinical Research, Baton Rough
state: Louisiana
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: Monroe
country: United States
facility: IMA Evaluations LLC
state: Louisiana
city: Columbia
country: United States
facility: Centennial Medical Group, PC
state: Maryland
city: Rockville
country: United States
facility: Velocity Clinical Research Rockville
state: Maryland
city: Gulfport
country: United States
facility: Velocity Clinical Research Gulfport
state: Mississippi
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Norfolk
country: United States
facility: Velocity Clinical Research, Norfolk
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research, Omaha
state: Nebraska
city: Las Vegas
country: United States
facility: Alliance for Multispecialty Research (AMR) LLC, Las Vegas
state: Nevada
city: Binghamton
country: United States
facility: Velocity Clinical Research, Binghamton
state: New York
city: East Syracuse
country: United States
facility: Velocity Clinical Research, Syracuse
state: New York
city: New York
country: United States
facility: Velocity Clinical Research, Vestal
state: New York
city: Raleigh
country: United States
facility: M3 Wake Research, Inc
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Velocity Clinical Research, Cleveland
state: Ohio
city: Medford
country: United States
facility: Velocity Clinical Research - Medford
state: Oregon
city: East Greenwich
country: United States
facility: Velocity Clinical Research-Providence
state: Rhode Island
city: Gaffney
country: United States
facility: Velocity Clinical Research, Gaffney
state: South Carolina
city: Spartanburg
country: United States
facility: Velocity Clinical Research, Spartanburg
state: South Carolina
city: Knoxville
country: United States
facility: AMR-Knoxville
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Dallas
country: United States
facility: Cedar Health Research, LLC
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Martin Diagnostic Clinic
state: Texas
city: Plano
country: United States
facility: ACRC trials Parent HQ
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: BBCR Holdings LLC dba JBR Clinical Research - Midvale Campus
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
city: Suffolk
country: United States
facility: Velocity Clinical Research, Suffolk
state: Virginia
city: Red Deer
country: Canada
facility: CARe Clinic
state: Alberta
city: Hvidovre
country: Denmark
facility: Amager-Hvidovre Hospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital, Roskilde
city: Paide
country: Estonia
facility: Vee Family Doctor's Center OY
city: Tallinn
country: Estonia
facility: OÜ Innomedica
city: Tallinn
country: Estonia
facility: Center for Clinical and Basic Research
city: Tallinn
country: Estonia
facility: Al Mare Perearstikeskus OÜ
city: Tallin
country: Estonia
facility: Merelahe Family Doctors Centre
city: Tartu
country: Estonia
facility: Clinical Research Centre
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Berlin
country: Germany
facility: emovis GmbH
city: Berlin
country: Germany
facility: Velocity Clinical Research, Berlin
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Essen
country: Germany
facility: Klinisches Forschungszentrum Dr. Hagemann am Hausarztzentrum am Germaniaplatz Dr.Hagemann/ Breider
city: Essen
country: Germany
facility: Studienzentrum Bocholderstrasse
city: Essen
country: Germany
facility: UHZ Klinische Forschung
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH
city: Hamburg
country: Germany
facility: Velocity Clinical Research, Hamburg
city: Hannover
country: Germany
facility: Klinische Forschung Hannover-Mitte GmbH
city: Karlsruhe
country: Germany
facility: Klinische Forschung Karlsruhe GmbH
city: Leipzig
country: Germany
facility: Velocity Clinical Research, Leipzig
city: Leipzig
country: Germany
facility: Studienzentrum FMZ Radowsky
city: Mainz
country: Germany
facility: Research Quist
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Stuttgart
country: Germany
facility: Studienzentrum Leitz Triderm
city: Karachi
country: Pakistan
facility: The Aga Khan University
city: Lahore
country: Pakistan
facility: Central Park Teaching Hospital
city: Silang
country: Philippines
facility: Silang Specialists Medical Center
state: Cavite
city: Davao City
country: Philippines
facility: Davao Medical School Foundation Inc. Hospital / NEMESIO F. ANLOCOTAN III
state: Davao Del Sur
city: Las Piñas
country: Philippines
facility: Las Pinas Doctors Hospital
state: Las Pinas City
city: Bulacan
country: Philippines
facility: Marilao Saint Michael Family Hospital, Inc
city: Cavite
country: Philippines
facility: CARE CT Group Inc. CARE Clinical Trials
city: Cavite
country: Philippines
facility: Health Index Multispecialty and Lying in Clinic
city: Cebu City
country: Philippines
facility: Norzel Medical and Diagnostic Clinic
city: Iloilo City
country: Philippines
facility: West Visayas State University Medical Center
city: Manila
country: Philippines
facility: Manila Doctors Hospital
city: Manila
country: Philippines
facility: Mary Johnston Hospital
city: Quezon City
country: Philippines
facility: Quirino Memorial Medical Center
city: Taguig
country: Philippines
facility: Ospital ng Makati
city: High Wycombe
country: United Kingdom
facility: Velocity High Wycombe
city: London
country: United Kingdom
facility: Velocity North London
city: Preston
country: United Kingdom
facility: Panthera Biopartners Ltd (Preston)
city: Rochdale
country: United Kingdom
facility: Panthera Biopartners Ltd (Manchester)
city: Sheffield
country: United Kingdom
facility: Panthera Biopartners (Sheffield)
Study officials:
affiliation: Seqirus
name: Clinical Program Director
role: STUDY_DIRECTOR
References: