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This Phase 2, randomized, observer-blind, dose-confirmation clinical study evaluated different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 1000 subjects were randomized into 1 of 4 possible treatment groups with approximately 250 participants per group. Every participant received an influenza vaccine injection on Day 1 and were to be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serology data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IIV-A Investigational | Experimental |
| |
| aIIV-B Investigational | Experimental |
| |
| aIIV-C Investigational | Experimental |
| |
| Licensed IIV | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1 | Biological | Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher hemagglutinin [HA] dose), 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: Geometric Mean Titer (GMT): Geometric Mean of Hemagglutination Inhibition (HI) Antibodies at Day 1 and Day 29 | GMTs on Day 1 (prior to vaccination) and Day 29 as determined by HI assay against each of the 4 vaccine strains. No hypothesis testing was performed for the primary immunogenicity objectives. | Day 1 and Day 29 |
| Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) (HI Assay) | Geometric mean of the fold increase in serum HI titer postvaccination (Day 29) compared to prevaccination (Day 1) for each of the 4 vaccine strains. | Day 1 to Day 29 |
| Immunogenicity Endpoint: Percentages of Subjects With HI Titers ≥1:40 at Day 1 and Day 29 | Percentages of subjects with HI titers ≥1:40 at Day 1 and Day 29 for each of the 4 vaccine strains. | Day 1 and Day 29 |
| Immunogenicity Endpoint: Percentage of Subjects With Seroconversion at Day 29 (HI Assay) | Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with prevaccination titer equal to or above the lower limit of quantitation (LLOQ; 1:10), or a postvaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI antibodies. | Day 1 to Day 29 |
| Immunogenicity Endpoint: GMT Ratio (HI Assay) | The GMT ratio is the geometric mean of the postvaccination HI titer for the investigational vaccine over the geometric mean of the postvaccination HI titer for the licensed IIV vaccine. The Day 29 GMT ratios are calculated for the investigational vaccines with reference to the licensed vaccine, ie, the Day 29 GMT ratios are the ratio of the Day 29 GMTs in the Investigational group (IIV-A Investigational, aIIV-B Investigational, or aIIV-C Investigational) compared with the Day 29 GMTs in the Licensed IIV group (ie, Investigational group/Licensed IIV group). As the licensed vaccine is the reference for the GMT ratio, this parameter is presented as "1" for the Licensed IIV group (ie, Licensed IIV group/Licensed IIV group). |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity Endpoint: GMT: Geometric Mean of Microneutralization (MN) Antibodies Titer at Days 1 and 29 | GMTs on Day 1 (prior to vaccination) and Day 29 as determined by MN assay against each of the 4 vaccine strains. | Day 1 and Day 29 |
| Immunogenicity Endpoint: GMFI (MN Assay) |
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Inclusion Criteria:
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
Individuals ≥50 years of age on the day of informed consent.
Individuals who have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
Individuals who can comply with study procedures including follow-up .
Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the study vaccination.
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Exclusion Criteria:
In order to participate in this study, all subjects must not meet ANY of the exclusion criteria described below:
Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so for at least 2 months after the study vaccination.
Progressive, unstable or uncontrolled clinical conditions.
Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study.
History of any medical condition considered an adverse event of special interest (AESI).
Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
Clinical conditions representing a contraindication to intramuscular administration of vaccines or blood draw.
Abnormal function of the immune system resulting from:
Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
Receipt of an investigational or non-registered medicinal product within 30 days prior to informed consent.
Receipt of any COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to informed consent or plan to receive any COVID-19 vaccine within 7 days from study vaccination
Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to informed consent or who are planning to receive any vaccine within 28 days from the study vaccines.
Study personnel or immediate family or household member of study personnel.
Receipt of any influenza vaccine within 6 months prior to informed consent, or plan to receive an influenza vaccine during the study period.
Acute (severe) febrile illness,
Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Program Director | Seqirus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMR Tempe | Tempe | Arizona | 85281 | United States | ||
| Marvel 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 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])
SEQIRUS discloses results from clinical studies within 12 months of completion of the study 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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| ID | Title | Description |
|---|---|---|
| FG000 | IIV-A Investigational | Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2022 | Mar 23, 2026 |
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|
| Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1 | Biological | Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), 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. |
|
| Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1 | Biological | Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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. |
|
| Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1 | Biological | Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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. |
|
| Day 29 |
| Solicited Local or Systemic AEs | Number and percentage of subjects with solicited local or systemic AEs for 7 days following vaccination, based on the subject reported data (electronic Diary [eDiary]). No hypothesis testing was performed for the primary safety objectives. | Day 1 through Day 7 |
| Severe Solicited Local or Systemic AEs | Number and percentage of subjects with severe solicited local or systemic AEs for 7 days following vaccination, based on the subject reported data (eDiary). | Day 1 through Day 7 |
| Unsolicited AEs | Number and percentage of subjects with unsolicited AEs for 28 days following vaccination | Day 1 to Day 29 |
| Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESIs) and Medically-attended Adverse Events (MAAEs) | Number and percentage of subjects with SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs | Day 1 to Day 181 |
Geometric mean of the fold increase in serum MN titer postvaccination (Day 29) compared to prevaccination (Day 1) for each of the 4 vaccine strains. |
| Day 1 to Day 29 |
| Immunogenicity Endpoint: Percentages of Subjects With Seroconversion at Day 29 (MN Assay) | Seroconversion is defined as ≥4-fold increase for subjects with prevaccination MN titers ≥LLOQ (1:10) or as ≥4*LLOQ (1:10) for subjects with prevaccination MN titer \ | Day 1 to Day 29 |
| Immunogenicity Endpoint: GMT Ratio (MN Assay) | The GMT ratio is the geometric mean of the postvaccination HI titer for the investigational vaccine over the geometric mean of the postvaccination HI titer for the licensed IIV vaccine. The Day 29 GMT ratios are calculated for the investigational vaccines with reference to the licensed vaccine, ie, the Day 29 GMT ratios are the ratio of the Day 29 GMTs in the Investigational group (IIV-A Investigational, aIIV-B Investigational, or aIIV-C Investigational) compared with the Day 29 GMTs in the Licensed IIV group (ie, Investigational group/Licensed IIV group). As the licensed vaccine is the reference for the GMT ratio, this parameter is presented as "1" for the Licensed IIV group (ie, Licensed IIV group/Licensed IIV group). | Day 29 |
| Huntington Beach |
| California |
| 92647 |
| United States |
| California Research Center | San Diego | California | 92123 | United States |
| The Lynn Institute of The Rockies | Colorado Springs | Colorado | 80920 | United States |
| Clinical Research Consulting, LLC | Milford | Connecticut | 06460 | United States |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | United States |
| Velocity Clinical Research - New Smyrna Beach | Edgewater | Florida | 32132 | United States |
| CenExel RCA | Hollywood | Florida | 33024 | United States |
| Health Awareness INC | Jupiter | Florida | 33458 | 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 |
| Platinum Research Network, LLC | Savannah | Georgia | 31405 | United States |
| Meridian Clinical Research - Savannah | Savannah | Georgia | 31406 | United States |
| AMR El Dorado | El Dorado | Kansas | 67042 | United States |
| AMR Lexington | Lexington | Kentucky | 40509 | United States |
| Meridian Clinical Research | Baton Rouge | Louisiana | 70808 | United States |
| Medpharmics, LLC | Metairie | Louisiana | 70006 | United States |
| Rockville Internal Medicine Group | Rockville | Maryland | 20854 | United States |
| MedPharmics LLC | Biloxi | Mississippi | 39531 | United States |
| Healthcare Research Network | Hazelwood | Missouri | 63042 | United States |
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | United States |
| Meridian Clinical Research | Bellevue | Nebraska | 68005 | United States |
| Meridian Clinical Research | Grand Island | Nebraska | 68803 | United States |
| Meridian Clinical Research, LLC | Lincoln | Nebraska | 68510 | United States |
| Alliance for Multispecialty Research, LLC, Las Vegas | Las Vegas | Nevada | 89119 | United States |
| Meridian Clinical Research (Binghamton, NY) | Binghamton | New York | 13901 | United States |
| Meridian Clinical Research, LLC | Endwell | New York | 13760 | United States |
| Velocity Clinical Research - Syracuse | Syracuse | New York | 13057 | United States |
| M3 Wake Research, Inc. | Raleigh | North Carolina | 27612 | United States |
| Meridian Clinical Research, LLC | Cincinnati | Ohio | 45219 | United States |
| Meridian Clinical Research, LLC | Cincinnati | Ohio | 45246 | United States |
| Aventiv Research, Inc. Columbus | Columbus | Ohio | 43213 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Velocity Clinical Research - Medford | Medford | Oregon | 97504 | United States |
| Velocity Clinical Research, Gaffney | Gaffney | South Carolina | 29340 | United States |
| Velocity Clinical Research - Greenville | Greenville | South Carolina | 29615 | United States |
| Velocity Clinical Research, Spartanburg | Spartanburg | South Carolina | 29303 | United States |
| Meridian Clinical Research - Dakota Dunes | Dakota Dunes | South Dakota | 57049 | United States |
| AMR Coastal Clinical Research | Knoxville | Tennessee | 37920 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
| Velocity Clinical Research - West Jordan | West Jordan | Utah | 84088 | United States |
| CVS pharmacy - Charlottesville | Charlottesville | Virginia | 22902 | United States |
| CVS pharmacy - Reston | Reston | Virginia | 20190 | United States |
| CVS pharmacy - Richmond | Richmond | Virginia | 23235 | United States |
| FG001 | aIIV-B Investigational | Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), 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. |
| FG002 | aIIV-C Investigational | Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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. |
| FG003 | Licensed IIV | Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IIV-A Investigational | Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), 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. |
| BG001 | aIIV-B Investigational | Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), 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. |
| BG002 | aIIV-C Investigational | Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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. |
| BG003 | Licensed IIV | Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| Body mass index | Note: 6 subjects did not have body mass index data. | Mean | Standard Deviation | kg/m^2 |
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| Vaccinated within 3 previous influenza seasons | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Immunogenicity Endpoint: Geometric Mean Titer (GMT): Geometric Mean of Hemagglutination Inhibition (HI) Antibodies at Day 1 and Day 29 | GMTs on Day 1 (prior to vaccination) and Day 29 as determined by HI assay against each of the 4 vaccine strains. No hypothesis testing was performed for the primary immunogenicity objectives. | Per Protocol Set, defined as all subjects in the Full Analysis Set* who correctly received the vaccine; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis; and were not excluded due to other reasons defined prior to unblinding or analysis, including subjects who withdrew informed consent prior to Day 28. *All subjects in the All Enrolled Set who were randomized, received study vaccination and provided immunogenicity data on Day 1 and Day 29 assessment. | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean titer | Day 1 and Day 29 |
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| Primary | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) (HI Assay) | Geometric mean of the fold increase in serum HI titer postvaccination (Day 29) compared to prevaccination (Day 1) for each of the 4 vaccine strains. | Per Protocol Set | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean fold increase | Day 1 to Day 29 |
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| Primary | Immunogenicity Endpoint: Percentages of Subjects With HI Titers ≥1:40 at Day 1 and Day 29 | Percentages of subjects with HI titers ≥1:40 at Day 1 and Day 29 for each of the 4 vaccine strains. | Per Protocol Set | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 and Day 29 |
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| Primary | Immunogenicity Endpoint: Percentage of Subjects With Seroconversion at Day 29 (HI Assay) | Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with prevaccination titer equal to or above the lower limit of quantitation (LLOQ; 1:10), or a postvaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI antibodies. | Per Protocol Set | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 to Day 29 |
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| Primary | Immunogenicity Endpoint: GMT Ratio (HI Assay) | The GMT ratio is the geometric mean of the postvaccination HI titer for the investigational vaccine over the geometric mean of the postvaccination HI titer for the licensed IIV vaccine. The Day 29 GMT ratios are calculated for the investigational vaccines with reference to the licensed vaccine, ie, the Day 29 GMT ratios are the ratio of the Day 29 GMTs in the Investigational group (IIV-A Investigational, aIIV-B Investigational, or aIIV-C Investigational) compared with the Day 29 GMTs in the Licensed IIV group (ie, Investigational group/Licensed IIV group). As the licensed vaccine is the reference for the GMT ratio, this parameter is presented as "1" for the Licensed IIV group (ie, Licensed IIV group/Licensed IIV group). | Per Protocol Set Per protocol, for each of the three investigational groups, the data are analyzed together with the Licensed IIV group for the outcome measure of HI GMT ratio (Outcome Measure 5). The underlying HI GMT summary data used for this inferential calculation are reported in Outcome Measure 1. | Posted | Geometric Mean | 95% Confidence Interval | GMT ratio | Day 29 |
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| Primary | Solicited Local or Systemic AEs | Number and percentage of subjects with solicited local or systemic AEs for 7 days following vaccination, based on the subject reported data (electronic Diary [eDiary]). No hypothesis testing was performed for the primary safety objectives. | Solicited Safety Set, defined as all subjects in the Exposed Set with any solicited safety data recorded by the subject in the eDiary, including solicited AEs, body temperature measurements or use of analgesics/antipyretics. | Posted | Count of Participants | Participants | Day 1 through Day 7 |
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| Primary | Severe Solicited Local or Systemic AEs | Number and percentage of subjects with severe solicited local or systemic AEs for 7 days following vaccination, based on the subject reported data (eDiary). | Solicited Safety Set | Posted | Count of Participants | Participants | Day 1 through Day 7 |
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| Primary | Unsolicited AEs | Number and percentage of subjects with unsolicited AEs for 28 days following vaccination | Unsolicited Safety Set, defined as all subjects in the All Exposed Set for whom safety was assessed after vaccination. | Posted | Count of Participants | Participants | Day 1 to Day 29 |
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| Primary | Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESIs) and Medically-attended Adverse Events (MAAEs) | Number and percentage of subjects with SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs | Unsolicited Safety Set, defined as all subjects in the All Exposed Set for whom safety was assessed after vaccination. | Posted | Count of Participants | Participants | Day 1 to Day 181 |
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| Secondary | Immunogenicity Endpoint: GMT: Geometric Mean of Microneutralization (MN) Antibodies Titer at Days 1 and 29 | GMTs on Day 1 (prior to vaccination) and Day 29 as determined by MN assay against each of the 4 vaccine strains. | Per Protocol Set | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean titer | Day 1 and Day 29 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Immunogenicity Endpoint: GMFI (MN Assay) | Geometric mean of the fold increase in serum MN titer postvaccination (Day 29) compared to prevaccination (Day 1) for each of the 4 vaccine strains. | Per Protocol Set | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean fold increase | Day 1 to Day 29 |
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| Secondary | Immunogenicity Endpoint: Percentages of Subjects With Seroconversion at Day 29 (MN Assay) | Seroconversion is defined as ≥4-fold increase for subjects with prevaccination MN titers ≥LLOQ (1:10) or as ≥4*LLOQ (1:10) for subjects with prevaccination MN titer \ | Per Protocol Set | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 to Day 29 |
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| Secondary | Immunogenicity Endpoint: GMT Ratio (MN Assay) | The GMT ratio is the geometric mean of the postvaccination HI titer for the investigational vaccine over the geometric mean of the postvaccination HI titer for the licensed IIV vaccine. The Day 29 GMT ratios are calculated for the investigational vaccines with reference to the licensed vaccine, ie, the Day 29 GMT ratios are the ratio of the Day 29 GMTs in the Investigational group (IIV-A Investigational, aIIV-B Investigational, or aIIV-C Investigational) compared with the Day 29 GMTs in the Licensed IIV group (ie, Investigational group/Licensed IIV group). As the licensed vaccine is the reference for the GMT ratio, this parameter is presented as "1" for the Licensed IIV group (ie, Licensed IIV group/Licensed IIV group). | Per Protocol Set Per protocol, for each of the three investigational groups, the data are analyzed together with the Licensed IIV group for the outcome measure of MN GMT ratio (Outcome Measure 13). The underlying MN GMT summary data used for this inferential calculation are reported in Outcome Measure 10. | Posted | Geometric Mean | 95% Confidence Interval | GMT ratio | Day 29 |
|
All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs).
All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set).
During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IIV-A Investigational | Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), 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. | 0 | 264 | 8 | 264 | 161 | 264 |
| EG001 | aIIV-B Investigational | Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), 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. | 0 | 263 | 5 | 263 | 162 | 263 |
| EG002 | aIIV-C Investigational | Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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. | 1 | 262 | 4 | 262 | 190 | 262 |
| EG003 | Licensed IIV | Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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. | 0 | 262 | 10 | 262 | 141 | 262 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute cardiac event | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Benign neoplasm of prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Hormone receptor positive HER2 negative breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Induration | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
|
Any publication by Institution or Investigator shall not be made before the first multicenter publication of the entire study results. Seqirus must be notified of any intent to publish data collected from the study and prior approval from Seqirus must be obtained prior to submission for publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | Seqirus | +1 855 358 8966 | seqirus.clinicaltrials@seqirus.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2022 | Mar 23, 2026 | SAP_001.pdf |
Not provided
| 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 |
Not provided
Not provided
|
|
| ≥65 years |
|
|
|
|
|
| Black or African American |
|
|
| Asian |
|
|
| American Indian or Alaska Native |
|
|
| Native Hawaiian or Pacific Islander |
|
|
| Other |
|
|
|
|
| No |
|
|
| A/H1N1 Day 29 HI GMT |
|
| A/H3N2 Day 1 HI GMT |
|
| A/H3N2 Day 29 HI GMT |
|
| B/Yamagata Day 1 HI GMT |
|
| B/Yamagata Day 29 HI GMT |
|
| B/Victoria Day 1 HI GMT |
|
| B/Victoria Day 29 HI GMT |
|
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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. |
| OG003 | Licensed IIV | Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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. |
|
|
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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.
| OG003 | Licensed IIV | Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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. |
|
|
| OG002 |
| aIIV-C Investigational |
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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. |
| OG003 | Licensed IIV | Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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. |
|
|
| aIIV-B Investigational |
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), 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. |
| OG002 | aIIV-C Investigational | Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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. |
| OG003 | Licensed IIV | Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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. |
|
|
| OG002 | aIIV-C Investigational | Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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. |
| OG003 | Licensed IIV | Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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. |
|
|
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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.
| OG003 | Licensed IIV | Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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. |
|
|
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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.
| OG003 | Licensed IIV | Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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. |
|
|
| OG002 |
| aIIV-C Investigational |
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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. |
| OG003 | Licensed IIV | Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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. |
|
|
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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. |
| OG003 | Licensed IIV | Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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. |
|
|
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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. |
| OG003 | Licensed IIV | Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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. |
|
|
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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. |
| OG003 | Licensed IIV | Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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. |
|
|
| aIIV-B Investigational |
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), 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. |
| OG002 | aIIV-C Investigational | Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), 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. |
| OG003 | Licensed IIV | Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), 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. |
|
|