Influenza, HumanPhase 3NCT06015282
The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older
A Phase 3 study testing Investigational aQIVc, licensed QIVr and licensed aQIV in people with Influenza, Human, run by Seqirus at 96 sites in 8 countries.
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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Investigational aQIVc, licensed QIVr and licensed aQIV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,741 participants
- Where
- 96 sitesin 8 countries
- Study dates
- 3 Nov 2023to 30 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
96 sites in 8 countries.
96 sites in 8 countries
United States51 sites
Velocity Clinical Research, Baton Rough
Baton Rouge, Louisiana, 70809
Velocity Clinical Research, Binghamton
Binghamton, New York, 13905
Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research
Chicago, Illinois, 60640
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Velocity Clinical Research Cincinnati
Cincinnati, Ohio, 45242
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
Velocity Clinical Research, Cleveland
Cleveland, Ohio, 44122
Centennial Medical Group, PC
Columbia, Maryland, 21075
Cedar Health Research, LLC
Dallas, Texas, 75251
USA and International Research Inc.
Doral, Florida, 33126
Velocity Clinical Research-Providence
East Greenwich, Rhode Island, 02818
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057
Velocity Clinical Research, New Smyrna Beach
Edgewater, Florida, 32132
Benchmark Research
Fort Worth, Texas, 76135
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, 29340
Velocity Clinical Research Gulfport
Gulfport, Mississippi, 39503
Great Lakes Clinical Trials, LLC. Ravenswood dba Flourish Research
Gurnee, Illinois, 60031
DM Clinical Research - Martin Diagnostic Clinic
Houston, Texas, 77065
Marvel Clinical Research
Huntington Beach, California, 92647
Health Awareness, Inc.
Jupiter, Florida, 33458
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, 64114
AMR-Knoxville
Knoxville, Tennessee, 37909
ARS - Lake Oconee
Largo, Florida, 33777
Alliance for Multispecialty Research (AMR) LLC, Las Vegas
Las Vegas, Nevada, 89119
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
Velocity Clinical Research - Medford
Medford, Oregon, 97504
Velocity Clinical Research- Boise
Meridian, Idaho, 83642
Benchmark Research
Metairie, Louisiana, 70006
Global Health Research Center
Miami Lakes, Florida, 33016
Clinical Research Consulting, Inc.
Milford, Connecticut, 06460
IMA Evaluations LLC
Monroe, Louisiana, 71201
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
Velocity Clinical Research, Vestal
New York, New York, 13850
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, 68701
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134
ACRC trials Parent HQ
Plano, Texas, 75024
M3 Wake Research, Inc
Raleigh, North Carolina, 27612
Paradigm Clinical Research Center, LLC
Redding, California, 96001
Velocity Clinical Research Rockville
Rockville, Maryland, 20854
BBCR Holdings LLC dba JBR Clinical Research - Midvale Campus
Salt Lake City, Utah, 84107
Velocity Clinical Research, Sioux City
Sioux City, Iowa, 51106
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina, 29303
Sundance Clinical Research
St Louis, Missouri, 63141
Velocity Clinical Research, Suffolk
Suffolk, Virginia, 23435
Precision Clinical Research
Sunrise, Florida, 33351
Global Health Research center
Tampa, Florida, 33615
Alliance for Multispecialty Research (AMR) Phoenix
Tempe, Arizona, 85281
DM Clinical Research
Tomball, Texas, 77375
Velocity Clinical Research Valparaoso
Valparaiso, Indiana, 46383
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088
Germany16 sites
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117
emovis GmbH
Berlin, 10629
Velocity Clinical Research, Berlin
Berlin, 10787
Klinische Forschung Dresden GmbH
Dresden, 01069
Klinisches Forschungszentrum Dr. Hagemann am Hausarztzentrum am Germaniaplatz Dr.Hagemann/ Breider
Essen, 45355
Studienzentrum Bocholderstrasse
Essen, 45355
UHZ Klinische Forschung
Essen, 45359
Klinische Forschung Hamburg GmbH
Hamburg, 20253
Velocity Clinical Research, Hamburg
Hamburg, 22143
Klinische Forschung Hannover-Mitte GmbH
Hanover, 30159
Klinische Forschung Karlsruhe GmbH
Karlsruhe, 76137
Velocity Clinical Research, Leipzig
Leipzig, 04177
Studienzentrum FMZ Radowsky
Leipzig, 04179
Research Quist
Mainz, 55128
Klinische Forschung Schwerin GmbH
Schwerin, 19055
Studienzentrum Leitz Triderm
Stuttgart, 70178
Philippines12 sites
Marilao Saint Michael Family Hospital, Inc
Bulacan
CARE CT Group Inc. CARE Clinical Trials
Cavite
Health Index Multispecialty and Lying in Clinic
Cavite
Norzel Medical and Diagnostic Clinic
Cebu City
Ospital ng Makati
City of Taguig, 1642
Davao Medical School Foundation Inc. Hospital / NEMESIO F. ANLOCOTAN III
Davao City, Davao Del Sur
West Visayas State University Medical Center
Iloilo City
Las Pinas Doctors Hospital
Las Piñas, Las Pinas City
Manila Doctors Hospital
Manila
Mary Johnston Hospital
Manila
Quirino Memorial Medical Center
Quezon City
Silang Specialists Medical Center
Silang, Cavite
Estonia7 sites
Vee Family Doctor's Center OY
Paide, 72713
OÜ Innomedica
Tallinn, 10117
Center for Clinical and Basic Research
Tallinn, 10128
Al Mare Perearstikeskus OÜ
Tallinn, 10617
Merelahe Family Doctors Centre
Tallinn, 10617
Clinical Research Centre
Tartu, 50106
Tartu University Hospital
Tartu, 50411
United Kingdom5 sites
Velocity High Wycombe
High Wycombe, HP112QW
Velocity North London
London, N128BU
Panthera Biopartners Ltd (Preston)
Preston, PR29RB
Panthera Biopartners Ltd (Manchester)
Rochdale, OL114AU
Panthera Biopartners (Sheffield)
Sheffield, S25FX
Denmark2 sites
Amager-Hvidovre Hospital
Hvidovre, 2650
Zealand University Hospital, Roskilde
Roskilde, 4000
Pakistan2 sites
The Aga Khan University
Karachi, 74800
Central Park Teaching Hospital
Lahore
About this study
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.
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.
- Conditions
- Influenza, Human
- Being tested
- Investigational aQIVc, licensed QIVr, licensed aQIV
- Keywords
- influenza, vaccine, MF59, Adjuvant
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational aQIVcBiological
Investigational 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 QIVrBiological
Recombinant Quadrivalent Influenza Vaccine (Flublok Quadrivalent/Supemtek) 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 aQIVBiological
Adjuvanted, egg-derived Quadrivalent Influenza Vaccine (Fluad) 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.
| Study group | Role | What they receive |
|---|---|---|
| Investigational aQIVc group | Experimental | Not described Receives: Biological: Investigational aQIVc |
| licensed QIVr group | Active comparator | Not described Receives: Biological: licensed QIVr |
| licensed aQIV group | Active comparator | Not described Receives: Biological: licensed aQIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 29
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.
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.
Measured: Day 29
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.
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.
Measured: Day 1 and Day 29
Secondary outcomes (10)
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.
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.
Measured: Day 1 and Day 29
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.
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.
Measured: Day 29
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.
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.
Measured: Day 1 and Day 29
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.
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.
Measured: Day 1 and Day 29
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.
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.
Measured: Day 1 up to Day 365
Immunogenicity Endpoints: For aQIVc, QIVr and aQIV 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.
Measured: Day 1 up to Day 365
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.
Measured: Day 1 to Day 7
Safety endpoints: For aQIVc, QIVr and aQIV vaccines, the percentage of Subjects with Unsolicited Adverse Events.
Measured: Day 1 to Day 29
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).
Measured: Day 1 to Day 181
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).
Long-term safety for the long-term subset of 770 subjects
Measured: Day 1 to Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start3 Nov 2023
- Primary completion5 Mar 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7,741 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seqirus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Program Director, Study director, Seqirus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015282
- Sponsor's protocol ID
- V201_03
- Status last verified
- Apr 2025
- First submitted
- 23 Aug 2023
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 Common Technical Document (CTD) modules submitted to regulatory agencies for public release. Summary results disclosure is either in document form (e.g., International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (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 \[EU CTR\])).
Publications
Essink BJ, Vermeulen W, Andrade C, Mazur M, de Rooij R, Heijnen E, Casula D, Xing R, Tovar MP, Garner V, Albano FR. Immunogenicity and safety of an MF59-adjuvanted cell-derived higher-dose quadrivalent influenza vaccine (aQIVc) in adults aged 50 years or older: a phase 3 randomised controlled trial. Lancet Infect Dis. 2026 Sep 10:S1473-3099(26)00410-X. doi: 10.1016/S1473-3099(26)00410-X. Online ahead of print.
PubMed 42721997de Looze F, Essink BJ, van Boxmeer J, Andrade C, de Rooij R, Casula D, Xing R, Tovar MP, Albano FR. Immunogenicity and safety of higher-dose cell-based adjuvanted quadrivalent influenza vaccines: Combined results of randomised, controlled dose-finding and dose-confirmation studies. Vaccine. 2026 Apr 19;79:128436. doi: 10.1016/j.vaccine.2026.128436. Epub 2026 Mar 19.
PubMed 41855648
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06015282
- Acronym / sponsor ID
- V201_03
- Conditions
- Influenza, Human
- Keywords
- influenza, vaccine, MF59, Adjuvant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,741 participants (actual)
- Lead sponsor
- SeqirusIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational aQIVc group | Experimental | Biological: Investigational aQIVc |
| licensed QIVr group | Active comparator | Biological: licensed QIVr |
| licensed aQIV group | Active comparator | Biological: licensed aQIV |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational aQIVcInvestigational 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. | Biological | Investigational aQIVc group |
| licensed QIVrRecombinant Quadrivalent Influenza Vaccine (Flublok Quadrivalent/Supemtek) 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. | Biological | licensed QIVr group |
| licensed aQIVAdjuvanted, egg-derived Quadrivalent Influenza Vaccine (Fluad) 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. | Biological | licensed aQIV group |
Primary outcome
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
10 secondary outcomes
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.
Time frame: Day 1 and Day 29
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.
Time frame: Day 29
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.
Time frame: Day 1 and Day 29
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.
Time frame: Day 1 and Day 29
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.
Time frame: Day 1 up to Day 365
Immunogenicity Endpoints: For aQIVc, QIVr and aQIV vaccines, GMT, GMFI, SCR, SCR difference, and GMT ratio of antibodies measured via MN assay.
Time frame: Day 1 up to Day 365
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.
Time frame: Day 1 to Day 7
Safety endpoints: For aQIVc, QIVr and aQIV vaccines, the percentage of Subjects with Unsolicited Adverse Events.
Time frame: Day 1 to Day 29
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).
Time frame: Day 1 to Day 181
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).
Time frame: Day 1 to Day 365
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Derived from this study: PubMed 42721997Essink BJ, Vermeulen W, Andrade C, Mazur M, de Rooij R, Heijnen E, Casula D, Xing R, Tovar MP, Garner V, Albano FR. Immunogenicity and safety of an MF59-adjuvanted cell-derived higher-dose quadrivalent influenza vaccine (aQIVc) in adults aged 50 years or older: a phase 3 randomised controlled trial. Lancet Infect Dis. 2026 Sep 10:S1473-3099(26)00410-X. doi: 10.1016/S1473-3099(26)00410-X. Online ahead of print.
- Derived from this study: PubMed 41855648de Looze F, Essink BJ, van Boxmeer J, Andrade C, de Rooij R, Casula D, Xing R, Tovar MP, Albano FR. Immunogenicity and safety of higher-dose cell-based adjuvanted quadrivalent influenza vaccines: Combined results of randomised, controlled dose-finding and dose-confirmation studies. Vaccine. 2026 Apr 19;79:128436. doi: 10.1016/j.vaccine.2026.128436. Epub 2026 Mar 19.
- Individual participant dataSharing planned: Yes. 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 Common Technical Document (CTD) modules submitted to regulatory agencies for public release. Summary results disclosure is either in document form (e.g., International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (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])).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Program Director study director
Seqirus
96 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Investigational aQIVc, licensed QIVr and licensed aQIV in people with Influenza, Human, run by Seqirus at 96 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 sites in United States, Germany, Philippines, Estonia, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Day 29). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06015282, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.