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

Influenza, Human Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06015282
• Other study ID #: V201_03
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 3, 2023
• Est. completion date: January 30, 2025

Study information

• Verified date: March 2024
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7741
• Est. completion date: January 30, 2025
• Est. primary completion date: March 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Biological:
• Investigational aQIVc
Investigational MF59 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 QIV1
Licensed, Quadrivalent Influenza Vaccine 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 QIV2
Licensed, Quadrivalent Influenza Vaccine 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.

Locations

Country	Name	City	State
Canada	CARe Clinic	Red Deer	Alberta
Denmark	Amager-Hvidovre Hospital	Hvidovre
Denmark	Zealand University Hospital, Roskilde	Roskilde
Estonia	Vee Family Doctor's Center OY	Paide
Estonia	Merelahe Family Doctors Centre	Tallin
Estonia	Al Mare Perearstikeskus OÜ	Tallinn
Estonia	Center for Clinical and Basic Research	Tallinn
Estonia	OÜ Innomedica	Tallinn
Estonia	Clinical Research Centre	Tartu
Estonia	Tartu University Hospital	Tartu
Germany	emovis GmbH	Berlin
Germany	Klinische Forschung Berlin	Berlin
Germany	Klinische Forschung Berlin-Mitte GmbH	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	Studienzentrum FMZ Radowsky	Leipzig
Germany	Velocity Clinical Research, Leipzig	Leipzig
Germany	Research Quist	Mainz
Germany	Klinische Forschung Schwerin GmbH	Schwerin
Germany	Studienzentrum Leitz Triderm	Stuttgart
Pakistan	The Aga Khan University	Karachi
Pakistan	Central Park Teaching Hospital	Lahore
Philippines	Marilao Saint Michael Family Hospital, Inc	Bulacan
Philippines	CARE CT Group Inc.	Cavite
Philippines	Health Index Multispecialty and Lying in Clinic	Cavite
Philippines	Norzel Medical and Diagnostic Clinic	Cebu City
Philippines	Davao Medical School Foundation Inc. Hospital / NEMESIO F. ANLOCOTAN III	Davao City	Davao Del Sur
Philippines	West Visayas State University Medical Center	Iloilo City
Philippines	Las Pinas Doctors Hospital	Las Piñas	Las Pinas City
Philippines	Ospital ng Makati	Makati City
Philippines	Manila Doctors Hospital	Manila
Philippines	Mary Johnston Hospital	Manila
Philippines	Quirino Memorial Medical Center	Quezon City
Philippines	Silang Specialists Medical Center	Silang	Cavite
United Kingdom	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 States	Velocity Clinical Research	Baton Rouge	Louisiana
United States	Velocity Clinical Research	Beachwood	Ohio
United States	Velocity Clinical Research	Binghamton	New York
United States	GLCT/Flourish Research	Chicago	Illinois
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Velocity Clinical Research Cincinnati Blue Ash	Cincinnati	Ohio
United States	Innovative Research of West Florida	Clearwater	Florida
United States	Cedar Health Research	Dallas	Texas
United States	USA and International Research Inc.	Doral	Florida
United States	Velocity Clinical Research-Providence	East Greenwich	Rhode Island
United States	Velocity Clinical Research, New Smyrna Beach	Edgewater	Florida
United States	Centennial Medical Group	Elkridge	Maryland
United States	Benchmark Research	Fort Worth	Texas
United States	Velocity Clinical Research, Gaffney	Gaffney	South Carolina
United States	Velocity Clinical Research	Gulfport	Mississippi
United States	Great Lakes Clinical Trials, a Flourish Research Site	Gurnee	Illinois
United States	DM Clinical Research	Houston	Texas
United States	Marvel Clinical Research	Huntington Beach	California
United States	Health Awareness, Inc.	Jupiter	Florida
United States	Alliance for Multispecialty Research-Kansas City	Kansas City	Missouri
United States	AMR-Knoxville	Knoxville	Tennessee
United States	Accel Research Sites Network, STP	Largo	Florida
United States	Alliance for Multispecialty Research LLC, Las Vegas	Las Vegas	Nevada
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Velocity Clinical Research - Medford	Medford	Oregon
United States	Velocity Clinical Research- Boise	Meridian	Idaho
United States	Benchmark Research	Metairie	Louisiana
United States	Global Health Research Center, Inc.	Miami Lakes	Florida
United States	Clinical Research Consulting, LLC	Milford	Connecticut
United States	JBR Clinical Research	Millcreek	Utah
United States	IMA Clinical Research	Monroe	Louisiana
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	Velocity Clinical Research	New York	New York
United States	Vestal, Velocity Clinical Research	New York	New York
United States	Velocity Clinical Research	Norfolk	Nebraska
United States	Velocity Clinical Research, Omaha	Omaha	Nebraska
United States	ACRC trials/ Village Health Partners	Plano	Texas
United States	Velocity Clinical Research	Portsmouth	Virginia
United States	M3 Wake Research, Inc	Raleigh	North Carolina
United States	Paradigm Clinical Research Center	Redding	California
United States	Velocity Clinical Research	Rockville	Maryland
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	Velocity Clinical Research, Sioux City	Sioux City	Iowa
United States	Velocity Clinical Research, Spartanburg	Spartanburg	South Carolina
United States	Precision Clinical Research	Sunrise	Florida
United States	Global Health Research center, Inc.	Tampa	Florida
United States	Alliance for Multispecialty Research (AMR) Phoenix	Tempe	Arizona
United States	DM Clinical Research	Tomball	Texas
United States	Velocity Clinical Research Valparaoso	Valparaiso	Indiana
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Velocity Clinical Research	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Estonia,  Germany,  Pakistan,  Philippines,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains.	Day 29
Primary	Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIV1 and QIV2 vaccines in terms of Day 29 GMT and GMT ratio of antibodies measured via HI assay.	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 (QIV1 or QIV2) 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.	Day 29
Primary	Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIV1 and QIV2 vaccines in terms of Day 1 to Day 29 SCR and SCR difference, from antibody titers measured via HI assay.	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 (QIV1 or QIV2) 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.	Day 1 and Day 29
Secondary	Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIV1 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.	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 HD/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 HD minus comparator) is =-10% for each of the 4 vaccine strains.	Day 1 and Day 29
Secondary	Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIV1 and QIV2 vaccines in terms of Day 29 GMT and GMT ratio of antibodies measured via HI assay.	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 (QIV1 and QIV2) 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.	Day 29
Secondary	Immunogenicity Endpoints: For aQIVc, QIV1, and QIV2 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.	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.	Day 1 and Day 29
Secondary	Immunogenicity Endpoints: For aQIVc and QIV1 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.	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.	Day 1 and Day 29
Secondary	Immunogenicity Endpoints: For aQIVc, QIV1 and QIV2 vaccines, GMT, GMFI, Percentage of subjects with HI titer =1:40, SCR, SCR differences, and GMT ratio of antibodies measured via HI assay.	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.	Day 1 up to Day 365
Secondary	Immunogenicity Endpoints: For aQIVc, QIV1 and QIV2 vaccines, GMT, GMFI, SCR, SCR difference, and GMT ratio of antibodies measured via MN assay.	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.	Day 1 up to Day 365
Secondary	Safety endpoints: For aQIVc, QIV1 and QIV2 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
Secondary	Safety endpoints: For aQIVc, QIV1 and QIV2 vaccines, the percentage of Subjects with Unsolicited Adverse Events.		Day 1 to Day 29
Secondary	Safety endpoints: For aQIVc, QIV1 and QIV2 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 181
Secondary	Safety endpoints: For aQIVc, QIV1 and QIV2 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).	Long-term safety for the long-term subset of 770 subjects	Day 1 to Day 365