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

NCT06015282
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Phase
Phase 3
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Recruitment status
Completed
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Participants
7,741
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Lead sponsor
Seqirus
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Start date
2023-11-03
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Number of sites
96
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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.
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Short title
The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older
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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.
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2025-01-30
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First posted
2023-08-29
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Registry last updated
2025-04-27
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Primary completion date
2024-03-05
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Start date
2023-11-03
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Actual participants
7,741
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Participants
7,741
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Participant count basis
Actual
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Protocol amendments
5
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Randomisation ratio
1:1:1:2
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Number of sites
96
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Seqirus
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06015282
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06015282
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. 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

    HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains.

  2. 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

    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.

  3. 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

    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.

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. 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

  8. Safety endpoints: For aQIVc, QIVr and aQIV vaccines, the percentage of Subjects with Unsolicited Adverse Events.

    Timeframe: Day 1 to Day 29

  9. 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

  10. 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

    Long-term safety for the long-term subset of 770 subjects

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
50 Years
Healthy volunteers
Yes

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.
Sources for eligibility
clinicaltrials.gov

  • Alliance for Multispecialty Research (AMR) PhoenixTempe, United States
  • Baptist Health Center for Clinical ResearchLittle Rock, United States
  • Marvel Clinical ResearchHuntington Beach, United States
  • Paradigm Clinical Research Center, LLCRedding, United States
  • Clinical Research Consulting, Inc.Milford, United States
  • Chase Medical Research, LLCWaterbury, United States
  • Innovative Research of West Florida, Inc.Clearwater, United States
  • USA and International Research Inc.Doral, United States
  • Velocity Clinical Research, New Smyrna BeachEdgewater, United States
  • Health Awareness, Inc.Jupiter, United States
  • ARS - Lake OconeeLargo, United States
  • Global Health Research CenterMiami Lakes, United States
  • Precision Clinical ResearchSunrise, United States
  • Global Health Research centerTampa, United States
  • Velocity Clinical Research- BoiseMeridian, United States
  • Great Lakes Clinical Trials, LLC Ravenswood dba Flourish ResearchChicago, United States
  • Great Lakes Clinical Trials, LLC. Ravenswood dba Flourish ResearchGurnee, United States
  • Velocity Clinical Research ValparaosoValparaiso, United States
  • Velocity Clinical Research, Sioux CitySioux City, United States
  • Velocity Clinical Research, Baton RoughBaton Rouge, United States
  • Benchmark ResearchMetairie, United States
  • IMA Evaluations LLCMonroe, United States
  • Centennial Medical Group, PCColumbia, United States
  • Velocity Clinical Research RockvilleRockville, United States
  • Velocity Clinical Research GulfportGulfport, United States

And 71 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)