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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

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
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United States of America
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Arizona
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Arkansas
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California
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Connecticut
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Florida
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Idaho
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Illinois
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Indiana
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Iowa
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Louisiana
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Maryland
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Mississippi
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Missouri
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Nebraska
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Nevada
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New York
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North Carolina
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Ohio
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Oregon
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Canada
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Alberta
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Denmark
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Hvidovre
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Denmark
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Roskilde
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Estonia
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Paide
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Estonia
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Tallinn
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Estonia
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Tallin
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Estonia
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Tartu
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Essen
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Karlsruhe
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Schwerin
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Germany
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Stuttgart
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Pakistan
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Karachi
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Pakistan
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Lahore
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Philippines
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Cavite
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Davao Del Sur
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Philippines
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Las Pinas city
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Makati city
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Philippines
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Bulacan
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Cebu City
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Philippines
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Iloilo City
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Philippines
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Manila
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Philippines
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Quezon City
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United Kingdom
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High Wycombe
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United Kingdom
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London
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United Kingdom
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Preston
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United Kingdom
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Rochdale
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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
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release.

Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry \[EU CTR\])).

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
SEQIRUS discloses results from clinical studies within 12 months of last patient last visit (LPLV) unless otherwise mandated by local laws or regulations.
Available to whom?
SEQIRUS will consider requests from qualified scientific and medical researchers to disclose protocols, anonymized subject-level data and study-level data when there is medical, scientific and/or public health interest to ensure the safe use of a Seqirus product licensed on or after 1 January 2014 in the United States (US) and/or the European Union (EU). This applies to Seqirus-sponsored interventional studies initiated after 27 September 2007 and ongoing as of 26 December 2007, that have been included as part of a US or EU submission package which received approval in US and EU on or after 1 January 2014 and have been accepted for publication.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.seqirus.us/partnering


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06015282