ImmunizationPhase 3NCT07890454
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
A Phase 3 study testing IIV-HD (standalone), NVXC19 (EU licensed, standalone) and IIV-HD + NVXC19 combination in people with Immunization and Healthy Volunteers, run by Sanofi.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunization, Healthy Volunteers, COVID-19 Immunization
- What is being tested?
- IIV-HD (standalone), NVXC19 (EU licensed, standalone) and IIV-HD + NVXC19 combination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,000 participants
- Where
- No sites listed yet
- Study dates
- 9 Nov 2026to 28 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
- 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
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
About this study
Official title: 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
- Being tested
- IIV-HD (standalone), NVXC19 (EU licensed, standalone), IIV-HD + NVXC19 combination, Placebo, normal saline
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IIV-HD (standalone)Drug
Pharmaceutical form: Suspension
Route of administration:
Intramuscular injection
NVXC19 (EU licensed, standalone)Drug
Pharmaceutical form: Dispersion Route of administration: Intramuscular injection
IIV-HD + NVXC19 combinationDrug
Pharmaceutical form: Suspension Route of administration: Intramuscular injection
Placebo, normal salineDrug
Pharmaceutical form: Solution Route of administration: Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1, IIV-HD and EU-licensed NVXC19 | Active comparator | IIV-HD and NVXC19 co-administered in opposite deltoid muscles Receives: Drug: IIV-HD (standalone); Drug: NVXC19 (EU licensed, standalone) |
| Group 2, IIV-HD + NVXC19 combination and placebo | Experimental | IIV-HD + NVXC19 and Placebo co-administered in opposite deltoid muscles Receives: Drug: IIV-HD + NVXC19 combination; Drug: Placebo, normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody titers against for each of the 3 influenza vaccine strains(in a subset of participants)
Geometric mean (GMT) of antibody titers measured by hemagglutination inhibition (HAI)
Measured: At Day 28 after vaccination
Antibody titers against SARS-CoV-2 specific variant(in a subset of participants)
Geometric mean (GMT) of antibody titers measured by pseudovirus neutralization test (PNT)
Measured: At Day 28 after vaccination
Secondary outcomes (22)
Presence of solicited injection site reactions for 8 days, including the day of vaccination (Main subset of participants)
Number of participants with solicited injection site reactions pre-listed in the participant diary and case report form (CRF)
Measured: Up to 8 each days after vaccination
Presence of solicited systemic reactions for 8 days, including the day of vaccination (Main subset of participants)
Number of participants with solicited systemic reactions pre-listed in the participant diary and case report form (CRF)
Measured: Up to 8 each days after vaccination
Presence of immediate adverse events after vaccination
Number of participants with immediate adverse events (AEs). Immediate adverse events are any unsolicited systemic adverse events within 30 minutes after vaccination
Measured: Within the 30 minutes after vaccination
Presence of unsolicited adverse events
Number of participants with unsolicited adverse events (AEs) for 28 days, including the day of vaccination
Measured: Up to 28 days after vaccination
Presence of all medically attended adverse events
Number of participants with medical attended adverse events (MAAEs) for 180 days, including the day of vaccination
Measured: Up to 180 days after vaccination
Presence of related medically attended adverse events linked to predefined potential immune-mediated diseases
Number of participants with medical attended adverse events (MAAEs) linked to predefined potential immune-mediated diseases (PIMDs) following the study vaccination
Measured: From Day 181 through 12 months following study vaccination
Presence of all adverse events of special interest
Number of participants with adverse events of special interest (AESIs) for 180 days, including the day of vaccination
Measured: Up to 180 days after vaccination
Presence of all serious adverse events
Number of participants with serious adverse events (SAEs) for 180 days, including the day of vaccination
Measured: Up to 180 days after vaccination
Presence of related serious adverse events
Number of participants with serious adverse events (SAEs) from D181 through 12 months following the last study vaccination
Measured: From Day 181 through 12 months following study vaccination
Presence of related adverse events of special interest
Number of participants with adverse events of special interest (AESIs) from D181 through 12 months following the last study vaccination
Measured: 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
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
Measured: From Day 181 through 12 months following study vaccination
Presence of adverse events leading to study discontinuation throughout the study
Number of participants with adverse events lead to study discontinuation
Measured: From Day 01 through 12 months
Influenza seroconversion status after vaccination for each of the 3 influenza vaccine strains
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
Measured: At Day 29
SARS-CoV-2 seroresponse status after vaccination
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
Measured: 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)
Neutralizing antibody titers [1/dil]
Measured: 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)
Individual neutralizing titers ratio Day 29/Day 01
Measured: At Day 01 and Day 29
Neutralizing antibody titer against each of the 3 influenza vaccine strains after vaccination(in a subset of participants)
Percentage of participants with neutralization test (NT) titer ≥ 10 (1/dil)
Measured: At Day 29
Neutralizing antibody titer against each of the 3 influenza vaccine strains after vaccination (in a subset of participants)
Percentage of participants with neutralization test (NT) titer ≥ 20 (1/dil)
Measured: At Day 29
Neutralizing antibody titer against each of the 3 influenza vaccine strains after vaccination (in a subset of participants)
Percentage of participants with neutralization test (NT) titer ≥ 40 (1/dil)
Measured: At Day 29
Neutralizing antibody titer against each of the 3 influenza vaccine strains after vaccination (in a subset of participants)
Percentage of participants with neutralization test (NT) titer ≥ 80 (1/dil)
Measured: 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)
Percentage of participants fold increase is defined in neutralization test (NT) antibody titer [post/pre] ≥ 2-fold rise from Day 01 to Day 29
Measured: 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)
Percentage of participants fold increase is defined in neutralization test (NT) antibody titer [post/pre] ≥ 4-fold rise from Day 01 to Day 29
Measured: At Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start9 Nov 2026 (estimated)
- Primary completion28 Dec 2027 (estimated)
- Study completion28 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunizationStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890454
- Sponsor's protocol ID
- VBT00004
- Other IDs
- 2026-526221-18, U1111-1332-8880
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07890454
- Acronym / sponsor ID
- VBT00004
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2026 (estimated)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 28 Dec 2027 (estimated)
- First posted
- 22 Oct 2026 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1, IIV-HD and EU-licensed NVXC19 | Active comparator | Drug: IIV-HD (standalone), Drug: NVXC19 (EU licensed, standalone)IIV-HD and NVXC19 co-administered in opposite deltoid muscles |
| Group 2, IIV-HD + NVXC19 combination and placebo | Experimental | Drug: IIV-HD + NVXC19 combination, Drug: Placebo, normal salineIIV-HD + NVXC19 and Placebo co-administered in opposite deltoid muscles |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and to comply with all study procedures
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| IIV-HD (standalone)Pharmaceutical form: Suspension Route of administration: Intramuscular injection | Drug | Group 1, IIV-HD and EU-licensed NVXC19 |
| NVXC19 (EU licensed, standalone)Pharmaceutical form: Dispersion Route of administration: Intramuscular injection | Drug | Group 1, IIV-HD and EU-licensed NVXC19 |
| IIV-HD + NVXC19 combinationPharmaceutical form: Suspension Route of administration: Intramuscular injection | Drug | Group 2, IIV-HD + NVXC19 combination and placebo |
| Placebo, normal salinePharmaceutical form: Solution Route of administration: Intramuscular injection | Drug | Group 2, IIV-HD + NVXC19 combination and placebo |
Primary outcome
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)
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)
22 secondary outcomes
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
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
Presence of immediate adverse events after vaccination
Time frame: Within the 30 minutes after vaccination
Presence of unsolicited adverse events
Time frame: Up to 28 days after vaccination
Presence of all medically attended adverse events
Time frame: 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
Presence of all adverse events of special interest
Time frame: Up to 180 days after vaccination
Presence of all serious adverse events
Time frame: Up to 180 days after vaccination
Presence of related serious adverse events
Time frame: 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
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
Presence of adverse events leading to study discontinuation throughout the study
Time frame: From Day 01 through 12 months
Influenza seroconversion status after vaccination for each of the 3 influenza vaccine strains
Time frame: At Day 29
SARS-CoV-2 seroresponse status after vaccination
Time frame: 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
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
Neutralizing antibody titer against each of the 3 influenza vaccine strains after vaccination(in a subset of participants)
Time frame: 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
Neutralizing antibody titer against each of the 3 influenza vaccine strains after vaccination (in a subset of participants)
Time frame: 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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- link to study on CTIS portalLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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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.
Trial Transparency email recommended (Toll free for US & Canada) contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IIV-HD (standalone), NVXC19 (EU licensed, standalone) and IIV-HD + NVXC19 combination in people with Immunization and Healthy Volunteers, run by Sanofi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. 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: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody titers against for each of the 3 influenza vaccine strains(in a subset of participants) (time frame: At Day 28 after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026.