Study of a Combination SARS-CoV-2 Recombinant Spike and High-Dose Inactivated Influenza Vaccine With Matrix-M Adjuvant in Adult Participants 60 Years of Age and Older

November 9, 2026 updated by: Sanofi

A Phase 3, Parallel, Randomized, Modified Double-Blind, Active-Controlled, Multi-Arm Study to Assess the Safety and Immunogenicity of a Combination Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Recombinant Spike and High-Dose Inactivated Influenza Vaccine With Matrix-M Adjuvant in Adult Participants 60 Years of Age and Older

The purpose of this study is to assess the safety and immunogenicity of IIV-HD + NVXC19 vaccine compared to seasonal influenza vaccine (IIV-HD) and COVID-19 vaccine, adjuvanted (NVXC19) coadministered in adult participants 60 years of age and older. Placebo will be coadministered in the IIV-HD + NVXC19 study group to control for the number of injections and to maintain observer-blinding. Thus, each participant will receive 2 injections at enrollment, one in each deltoid muscle.

Study details include:

  • The study duration will be approximately 12 months per participant
  • Study intervention will be administered via a single IM injection into the right and left deltoid muscles on day (D)01

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • Poland
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-088
        • Recruiting
        • Investigational Site Number : 6160002
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-384
        • Recruiting
        • Investigational Site Number : 6160020

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria

Inclusion criteria to be checked at Screening Visit:

  • Aged 60 years or older on the day of inclusion
  • Informed consent form has been signed and dated
  • Able to attend all scheduled visits and to comply with all study procedures
  • Participant must be able to receive an injection in the deltoid muscle of both arms
  • Participant must have completed a primary vaccination series against SARS-CoV-2 and at least 1 booster with a locally authorized or approved COVID-19 vaccine Inclusion criteria to be checked at Visit 1 (D01)
  • Aged 60 years or older on the day of inclusion
  • Participants who are healthy or with pre-existing stable condition, as determined by medical evaluation including medical history and physical examination
  • Non-childbearing potential (i.e., post-menopausal for at least 1 year or surgically sterile)
  • lnformed consent form has been signed and dated
  • Able to attend all scheduled visits and to comply with all study procedures
  • Participant must be able to receive an injection in the deltoid muscle of both arms
  • Participant must have completed a primary vaccination series against SARS-CoV-2 and at least 1 booster with a locally authorized or approved COVID-19 vaccine

Exclusion criteria Exclusion Criteria to be Checked at Screening Visit and at Visit 1 (D01) Medical conditions

  • Known/suspected immunodeficiency; immunosuppressive therapy in past 6 months; long-term systemic corticosteroids
  • Known systemic hypersensitivity to any study intervention components or history of life-threatening reaction to study interventions or products with the same substances
  • Self-reported thrombocytopenia, contraindicating intramuscular injection, based on investigator's judgment
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection, based on investigator's judgment
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
  • Moderate/severe acute illness/infection (per investigator judgment)/fever (≥38.0°C [≥100.4°F]) on study intervention day. Include participant only after the condition or fever has resolved.
  • Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
  • History of serious adverse reaction to any influenza or COVID-19 vaccines per investigator's judgment
  • Personal or family history of Guillain-Barré syndrome
  • Prior history of myocarditis, pericarditis, or myopericarditis Prior/concomitant therapy
  • Any vaccine given within 4 weeks before or within 4 weeks after study intervention
  • Previous vaccination against influenza (in the previous 6 months before study intervention) with an investigational or marketed vaccine OR history of influenza infection in the previous 6 months
  • Previous vaccination against COVID-19 (in the previous 6 months before study intervention) with an investigational or marketed vaccine OR history of COVID-19 infection in the previous 6 months
  • Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months Other exclusion
  • Deprived of freedom by an administrative or court order, or being in an emergency setting, or hospitalized involuntarily
  • Is an investigator, investigator/study center employee, or immediate family member (parent, spouse, natural/adopted child) of the investigator/employee with direct involvement in the study The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1, IIV-HD and EU-licensed NVXC19

IIV-HD and NVXC19 co-administered in opposite deltoid muscles
Drug: IIV-HD (standalone)

Pharmaceutical form: Suspension

Route of administration:

Intramuscular injection

Drug: NVXC19 (EU licensed, standalone)

Pharmaceutical form: Dispersion Route of administration: Intramuscular injection
Experimental: Group 2, IIV-HD + NVXC19 combination and placebo

IIV-HD + NVXC19 and Placebo co-administered in opposite deltoid muscles
Drug: IIV-HD + NVXC19 combination

Pharmaceutical form: Suspension Route of administration: Intramuscular injection

Drug: Placebo, normal saline

Pharmaceutical form: Solution Route of administration: Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Antibody titers against for each of the 3 influenza vaccine strains(in a subset of participants)
Time Frame: At Day 28 after vaccination

Geometric mean (GMT) of antibody titers measured by hemagglutination inhibition (HAI)
At Day 28 after vaccination
Antibody titers against SARS-CoV-2 specific variant(in a subset of participants)
Time Frame: At Day 28 after vaccination

Geometric mean (GMT) of antibody titers measured by pseudovirus neutralization test (PNT)
At Day 28 after vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Presence of solicited injection site reactions for 8 days, including the day of vaccination (Main subset of participants)
Time Frame: Up to 8 each days after vaccination

Number of participants with solicited injection site reactions pre-listed in the participant diary and case report form (CRF)
Up to 8 each days after vaccination
Presence of solicited systemic reactions for 8 days, including the day of vaccination (Main subset of participants)
Time Frame: Up to 8 each days after vaccination

Number of participants with solicited systemic reactions pre-listed in the participant diary and case report form (CRF)
Up to 8 each days after vaccination
Presence of immediate adverse events after vaccination
Time Frame: Within the 30 minutes after vaccination

Number of participants with immediate adverse events (AEs). Immediate adverse events are any unsolicited systemic adverse events within 30 minutes after vaccination
Within the 30 minutes after vaccination
Presence of unsolicited adverse events
Time Frame: Up to 28 days after vaccination

Number of participants with unsolicited adverse events (AEs) for 28 days, including the day of vaccination
Up to 28 days after vaccination
Presence of all medically attended adverse events
Time Frame: Up to 180 days after vaccination

Number of participants with medical attended adverse events (MAAEs) for 180 days, including the day of vaccination
Up to 180 days after vaccination
Presence of related medically attended adverse events linked to predefined potential immune-mediated diseases
Time Frame: From Day 181 through 12 months following study vaccination

Number of participants with medical attended adverse events (MAAEs) linked to predefined potential immune-mediated diseases (PIMDs) following the study vaccination
From Day 181 through 12 months following study vaccination
Presence of all adverse events of special interest
Time Frame: Up to 180 days after vaccination

Number of participants with adverse events of special interest (AESIs) for 180 days, including the day of vaccination
Up to 180 days after vaccination
Presence of all serious adverse events
Time Frame: Up to 180 days after vaccination

Number of participants with serious adverse events (SAEs) for 180 days, including the day of vaccination
Up to 180 days after vaccination
Presence of related serious adverse events
Time Frame: From Day 181 through 12 months following study vaccination

Number of participants with serious adverse events (SAEs) from D181 through 12 months following the last study vaccination
From Day 181 through 12 months following study vaccination
Presence of related adverse events of special interest
Time Frame: From Day 181 through 12 months following study vaccination

Number of participants with adverse events of special interest (AESIs) from D181 through 12 months following the last study vaccination
From Day 181 through 12 months following study vaccination
Presence of related medical attended adverse events linked to predefined potential immune-mediated diseases that meet the criteria for serious adverse events
Time Frame: From Day 181 through 12 months following study vaccination

Number of patients with medical attended adverse events (MAAES) linked to predefined potential immune-mediated diseases (PIMDs) meets criteria for serious adverse events (SAEs) from D181 through 12 months following the last study vaccination
From Day 181 through 12 months following study vaccination
Presence of adverse events leading to study discontinuation throughout the study
Time Frame: From Day 01 through 12 months

Number of participants with adverse events lead to study discontinuation
From Day 01 through 12 months
Influenza seroconversion status after vaccination for each of the 3 influenza vaccine strains
Time Frame: At Day 29

Percentage of participants Seroconversion is defined by: pre-injection antibody titer < 10 [1/dil] at D01 and post-injection antibody titer ≥ 40 [1/dil] at D29, or pre-injection antibody titer ≥ 10 [1/dil] at D01 and a ≥ 4-fold increase in titer at D29
At Day 29
SARS-CoV-2 seroresponse status after vaccination
Time Frame: At Day 29

Percentage of participantsSeroresponse to SARS-CoV-2 is defined by: pre-injection antibody titer < LLOQ [1/dil] and post-injection antibody titer ≥ 4*LLOQ [1/dil] at D29, or pre-injection antibody titer ≥ LLOQ [1/dil] at D01 and a ≥ 4-fold increase in titer [1/dil] at D29
At Day 29
Neutralizing antibody titers measured by neutralization test (NT) against each of the 3 influenza vaccine strains before and after vaccination (in a subset of participants)
Time Frame: At Day 01 and Day 29

Neutralizing antibody titers [1/dil]
At Day 01 and Day 29
Individual neutralizing antibody titer ratio measured by neutralization test NT against each of the 3 influenza vaccine strains after vaccination (in a subset of participants)
Time Frame: At Day 01 and Day 29

Individual neutralizing titers ratio Day 29/Day 01
At Day 01 and Day 29
Neutralizing antibody titer against each of the 3 influenza vaccine strains after vaccination(in a subset of participants)
Time Frame: At Day 29

Percentage of participants with neutralization test (NT) titer ≥ 10 (1/dil)
At Day 29
Neutralizing antibody titer against each of the 3 influenza vaccine strains after vaccination (in a subset of participants)
Time Frame: At Day 29

Percentage of participants with neutralization test (NT) titer ≥ 20 (1/dil)
At Day 29
Neutralizing antibody titer against each of the 3 influenza vaccine strains after vaccination (in a subset of participants)
Time Frame: At Day 29

Percentage of participants with neutralization test (NT) titer ≥ 40 (1/dil)
At Day 29
Neutralizing antibody titer against each of the 3 influenza vaccine strains after vaccination (in a subset of participants)
Time Frame: At Day 29

Percentage of participants with neutralization test (NT) titer ≥ 80 (1/dil)
At Day 29
Fold increase in neutralization test antibody titer against each of the 3 influenza vaccine strains after vaccination (in a subset of participants)
Time Frame: At Day 29

Percentage of participants fold increase is defined in neutralization test (NT) antibody titer [post/pre] ≥ 2-fold rise from Day 01 to Day 29
At Day 29
Fold increase in neutralization test antibody titer against each of the 3 influenza vaccine strains after vaccination (in a subset of participants)
Time Frame: At Day 29

Percentage of participants fold increase is defined in neutralization test (NT) antibody titer [post/pre] ≥ 4-fold rise from Day 01 to Day 29
At Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 28, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VBT00004
  • 2026-526221-18 (Registry Identifier: CTIS EU)
  • U1111-1332-8880 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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