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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational aQIVc group | Experimental |
| |
| licensed QIVr group | Active Comparator |
| |
| licensed aQIV group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational aQIVc | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. | 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. | Day 1 and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Program Director | Seqirus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance for Multispecialty Research (AMR) Phoenix | Tempe | Arizona | 85281 | United States | ||
| Baptist Health Center for Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41855648 | Derived | de 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. |
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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])).
SEQIRUS discloses results from clinical studies within 12 months of last patient last visit (LPLV) unless otherwise mandated by local laws or regulations.
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.
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|
| licensed QIVr | Biological | 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 aQIV | Biological | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | Day 1 to Day 7 |
| Safety endpoints: For aQIVc, QIVr and aQIV vaccines, the percentage of Subjects with Unsolicited Adverse Events. | 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). | 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 | Day 1 to Day 365 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Marvel Clinical Research | Huntington Beach | California | 92647 | United States |
| Paradigm Clinical Research Center, LLC | Redding | California | 96001 | United States |
| Clinical Research Consulting, Inc. | Milford | Connecticut | 06460 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | United States |
| USA and International Research Inc. | Doral | Florida | 33126 | United States |
| Velocity Clinical Research, New Smyrna Beach | Edgewater | Florida | 32132 | United States |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | United States |
| ARS - Lake Oconee | Largo | Florida | 33777 | United States |
| Global Health Research Center | Miami Lakes | Florida | 33016 | United States |
| Precision Clinical Research | Sunrise | Florida | 33351 | United States |
| Global Health Research center | Tampa | Florida | 33615 | United States |
| Velocity Clinical Research- Boise | Meridian | Idaho | 83642 | United States |
| Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research | Chicago | Illinois | 60640 | United States |
| Great Lakes Clinical Trials, LLC. Ravenswood dba Flourish Research | Gurnee | Illinois | 60031 | United States |
| Velocity Clinical Research Valparaoso | Valparaiso | Indiana | 46383 | United States |
| Velocity Clinical Research, Sioux City | Sioux City | Iowa | 51106 | United States |
| Velocity Clinical Research, Baton Rough | Baton Rouge | Louisiana | 70809 | United States |
| Benchmark Research | Metairie | Louisiana | 70006 | United States |
| IMA Evaluations LLC | Monroe | Louisiana | 71201 | United States |
| Centennial Medical Group, PC | Columbia | Maryland | 21075 | United States |
| Velocity Clinical Research Rockville | Rockville | Maryland | 20854 | United States |
| Velocity Clinical Research Gulfport | Gulfport | Mississippi | 39503 | United States |
| Alliance for Multispecialty Research, LLC | Kansas City | Missouri | 64114 | United States |
| Sundance Clinical Research | St Louis | Missouri | 63141 | United States |
| Velocity Clinical Research, Norfolk | Norfolk | Nebraska | 68701 | United States |
| Velocity Clinical Research, Omaha | Omaha | Nebraska | 68134 | United States |
| Alliance for Multispecialty Research (AMR) LLC, Las Vegas | Las Vegas | Nevada | 89119 | United States |
| Velocity Clinical Research, Binghamton | Binghamton | New York | 13905 | United States |
| Velocity Clinical Research, Syracuse | East Syracuse | New York | 13057 | United States |
| Velocity Clinical Research, Vestal | New York | New York | 13850 | United States |
| M3 Wake Research, Inc | Raleigh | North Carolina | 27612 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Velocity Clinical Research Cincinnati | Cincinnati | Ohio | 45242 | United States |
| Velocity Clinical Research, Cleveland | Cleveland | Ohio | 44122 | United States |
| Velocity Clinical Research - Medford | Medford | Oregon | 97504 | United States |
| Velocity Clinical Research-Providence | East Greenwich | Rhode Island | 02818 | United States |
| Velocity Clinical Research, Gaffney | Gaffney | South Carolina | 29340 | United States |
| Velocity Clinical Research, Spartanburg | Spartanburg | South Carolina | 29303 | United States |
| AMR-Knoxville | Knoxville | Tennessee | 37909 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| Cedar Health Research, LLC | Dallas | Texas | 75251 | United States |
| Benchmark Research | Fort Worth | Texas | 76135 | United States |
| DM Clinical Research - Martin Diagnostic Clinic | Houston | Texas | 77065 | United States |
| ACRC trials Parent HQ | Plano | Texas | 75024 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| BBCR Holdings LLC dba JBR Clinical Research - Midvale Campus | Salt Lake City | Utah | 84107 | United States |
| Velocity Clinical Research, Salt Lake City | West Jordan | Utah | 84088 | United States |
| Velocity Clinical Research, Suffolk | Suffolk | Virginia | 23435 | United States |
| CARe Clinic | Red Deer | Alberta | T4P1K4 | Canada |
| Amager-Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Zealand University Hospital, Roskilde | Roskilde | 4000 | Denmark |
| Vee Family Doctor's Center OY | Paide | 72713 | Estonia |
| OÜ Innomedica | Tallinn | 10117 | Estonia |
| Center for Clinical and Basic Research | Tallinn | 10128 | Estonia |
| Al Mare Perearstikeskus OÜ | Tallinn | 10617 | Estonia |
| Merelahe Family Doctors Centre | Tallinn | 10617 | Estonia |
| Clinical Research Centre | Tartu | 50106 | Estonia |
| Tartu University Hospital | Tartu | 50411 | Estonia |
| Klinische Forschung Berlin-Mitte GmbH | Berlin | 10117 | Germany |
| emovis GmbH | Berlin | 10629 | Germany |
| Velocity Clinical Research, Berlin | Berlin | 10787 | Germany |
| Klinische Forschung Dresden GmbH | Dresden | 01069 | Germany |
| Klinisches Forschungszentrum Dr. Hagemann am Hausarztzentrum am Germaniaplatz Dr.Hagemann/ Breider | Essen | 45355 | Germany |
| Studienzentrum Bocholderstrasse | Essen | 45355 | Germany |
| UHZ Klinische Forschung | Essen | 45359 | Germany |
| Klinische Forschung Hamburg GmbH | Hamburg | 20253 | Germany |
| Velocity Clinical Research, Hamburg | Hamburg | 22143 | Germany |
| Klinische Forschung Hannover-Mitte GmbH | Hanover | 30159 | Germany |
| Klinische Forschung Karlsruhe GmbH | Karlsruhe | 76137 | Germany |
| Velocity Clinical Research, Leipzig | Leipzig | 04177 | Germany |
| Studienzentrum FMZ Radowsky | Leipzig | 04179 | Germany |
| Research Quist | Mainz | 55128 | Germany |
| Klinische Forschung Schwerin GmbH | Schwerin | 19055 | Germany |
| Studienzentrum Leitz Triderm | Stuttgart | 70178 | Germany |
| The Aga Khan University | Karachi | 74800 | Pakistan |
| Central Park Teaching Hospital | Lahore | Pakistan |
| Silang Specialists Medical Center | Silang | Cavite | Philippines |
| Davao Medical School Foundation Inc. Hospital / NEMESIO F. ANLOCOTAN III | Davao City | Davao Del Sur | Philippines |
| Las Pinas Doctors Hospital | Las Piñas | Las Pinas City | Philippines |
| Marilao Saint Michael Family Hospital, Inc | Bulacan | Philippines |
| CARE CT Group Inc. CARE Clinical Trials | Cavite | Philippines |
| Health Index Multispecialty and Lying in Clinic | Cavite | Philippines |
| Norzel Medical and Diagnostic Clinic | Cebu City | Philippines |
| Ospital ng Makati | City of Taguig | 1642 | Philippines |
| West Visayas State University Medical Center | Iloilo City | Philippines |
| Manila Doctors Hospital | Manila | Philippines |
| Mary Johnston Hospital | Manila | Philippines |
| Quirino Memorial Medical Center | Quezon City | Philippines |
| Velocity High Wycombe | High Wycombe | HP112QW | United Kingdom |
| Velocity North London | London | N128BU | United Kingdom |
| Panthera Biopartners Ltd (Preston) | Preston | PR29RB | United Kingdom |
| Panthera Biopartners Ltd (Manchester) | Rochdale | OL114AU | United Kingdom |
| Panthera Biopartners (Sheffield) | Sheffield | S25FX | United Kingdom |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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