Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06015282




Registration number
NCT06015282
Ethics application status
Date submitted
23/08/2023
Date registered
29/08/2023
Date last updated
19/11/2024

Titles & IDs
Public title
The Celljuvant Study: a Phase 3 Immunogenicity and Safety Study of AQIVc Vaccine in Adults Aged 50 Years and Older
Scientific 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.
Secondary ID [1] 0 0
V201_03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza, Human 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Investigational aQIVc
Treatment: Other - licensed QIV1
Treatment: Other - licensed QIV2

Experimental: Investigational aQIVc group -

Active comparator: licensed QIV1 group -

Active comparator: licensed QIV2 group -


Treatment: Other: 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.

Treatment: Other: 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.

Treatment: Other: 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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 29
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Day 29
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Day 1 and Day 29
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 1 and Day 29
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Day 29
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Day 1 and Day 29
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Day 1 and Day 29
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Day 1 up to Day 365
Secondary outcome [6] 0 0
Immunogenicity Endpoints: For aQIVc, QIV1 and QIV2 vaccines, GMT, GMFI, SCR, SCR difference, and GMT ratio of antibodies measured via MN assay.
Timepoint [6] 0 0
Day 1 up to Day 365
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Day 1 to Day 7
Secondary outcome [8] 0 0
Safety endpoints: For aQIVc, QIV1 and QIV2 vaccines, the percentage of Subjects with Unsolicited Adverse Events.
Timepoint [8] 0 0
Day 1 to Day 29
Secondary outcome [9] 0 0
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).
Timepoint [9] 0 0
Day 1 to Day 181
Secondary outcome [10] 0 0
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).
Timepoint [10] 0 0
Day 1 to Day 365

Eligibility
Key inclusion criteria
Main

* 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/01/2025
Actual
Sample size
Target
Accrual to date
Final
7741
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Rhode Island
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
Canada
State/province [26] 0 0
Alberta
Country [27] 0 0
Denmark
State/province [27] 0 0
Hvidovre
Country [28] 0 0
Denmark
State/province [28] 0 0
Roskilde
Country [29] 0 0
Estonia
State/province [29] 0 0
Paide
Country [30] 0 0
Estonia
State/province [30] 0 0
Tallinn
Country [31] 0 0
Estonia
State/province [31] 0 0
Tallin
Country [32] 0 0
Estonia
State/province [32] 0 0
Tartu
Country [33] 0 0
Germany
State/province [33] 0 0
Berlin
Country [34] 0 0
Germany
State/province [34] 0 0
Dresden
Country [35] 0 0
Germany
State/province [35] 0 0
Essen
Country [36] 0 0
Germany
State/province [36] 0 0
Hamburg
Country [37] 0 0
Germany
State/province [37] 0 0
Hannover
Country [38] 0 0
Germany
State/province [38] 0 0
Karlsruhe
Country [39] 0 0
Germany
State/province [39] 0 0
Leipzig
Country [40] 0 0
Germany
State/province [40] 0 0
Mainz
Country [41] 0 0
Germany
State/province [41] 0 0
Schwerin
Country [42] 0 0
Germany
State/province [42] 0 0
Stuttgart
Country [43] 0 0
Pakistan
State/province [43] 0 0
Karachi
Country [44] 0 0
Pakistan
State/province [44] 0 0
Lahore
Country [45] 0 0
Philippines
State/province [45] 0 0
Cavite
Country [46] 0 0
Philippines
State/province [46] 0 0
Davao Del Sur
Country [47] 0 0
Philippines
State/province [47] 0 0
Las Pinas city
Country [48] 0 0
Philippines
State/province [48] 0 0
Makati city
Country [49] 0 0
Philippines
State/province [49] 0 0
Bulacan
Country [50] 0 0
Philippines
State/province [50] 0 0
Cebu City
Country [51] 0 0
Philippines
State/province [51] 0 0
Iloilo City
Country [52] 0 0
Philippines
State/province [52] 0 0
Manila
Country [53] 0 0
Philippines
State/province [53] 0 0
Quezon City
Country [54] 0 0
United Kingdom
State/province [54] 0 0
High Wycombe
Country [55] 0 0
United Kingdom
State/province [55] 0 0
London
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Preston
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Rochdale
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seqirus
Address
Country

Ethics approval
Ethics application status

Summary
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, 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 website
https://clinicaltrials.gov/study/NCT06015282
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Clinical Program Director
Address 0 0
Seqirus
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06015282