COVID-19Phase 4NCT07861542
Study of a Recombinant Spike COVID-19 Vaccine With Matrix-M in Older Adults and People at Increased Risk of Severe COVID-19
A Phase 4 study testing Omicron Subvariant-Based SARS-CoV-2 Recombinant Spike Vaccine Adjuvanted With Matrix-M in people with COVID-19, run by Sanofi at 20 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of a single dose of Sanofi's Omicron subvariant-based Nuvaxovid in participants ≥ 65 years of age and participants 12 through 64 years of age who have at least one underlying condition that puts them at increased risk for severe outcomes of… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Omicron Subvariant-Based SARS-CoV-2 Recombinant Spike Vaccine Adjuvanted With Matrix-M
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 20 sitesUnited States
- Study dates
- 1 Oct 2026to 27 Jan 2027
- Phase
- Phase 4
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To be included in this study, each individual must satisfy all the following criteria:
- Participants ≥ 65 years of age, or participants 12 through 64 years of age who have at least 1 underlying condition that puts them at increased risk for severe outcomes from COVID-19 at the time of study vaccination.
- Previously vaccinated with a COVID-19 vaccine, with the last dose administered ≥ 90 days prior to study vaccination.
- Participants must not be pregnant or breastfeeding. Participants of childbearing potential must have a negative highly sensitive pregnancy test at enrollment and must agree to use an effective method of contraception or remain abstinent from ≥ 4 weeks before study vaccination through ≥ 4 weeks after vaccination.
Who cannot join
- Participants are not eligible if any of the following criteria are met:
- Known or suspected congenital or acquired immunodeficiency; receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the past 6 months; or long-term use of systemic corticosteroids.
- History of virologically confirmed SARS-CoV-2 infection within 90 days before study vaccination.
- Known systemic hypersensitivity to any component of the study intervention or a history of a life-threatening reaction to the study intervention or to a product containing the same substances.
- Prior history of myocarditis, pericarditis, or myopericarditis.
- Receipt of any vaccine within 28 days before study vaccination, except for influenza vaccine, which may be administered at least 14 days before study vaccination.
- Receipt of an investigational or marketed COVID-19 vaccine within 90 days before study vaccination.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free number for US & Canada) contact
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
Site #: 8400008
Atlanta, Georgia, 30329
- Recruiting
Site #: 8400018
Austin, Texas, 78750
- Recruiting
Site #: 8400016
Cincinnati, Ohio, 45219
- Recruiting
Site #: 8400015
Decatur, Georgia, 30030
- Recruiting
Site #: 8400002
Doral, Florida, 33172
- Recruiting
Site #: 8400005
Fair Oaks, California, 95628
- Recruiting
Site #: 8400017
Frisco, Texas, 75033
- Recruiting
Site #: 8400023
Grand Island, Nebraska, 68803
- Recruiting
Site #: 8400014
Houston, Texas, 77065
- Recruiting
Site #: 8400001
Lafayette, Louisiana, 70508
- Recruiting
Site #: 8400009
Lenexa, Kansas, 66219
- Recruiting
Site #: 8400011
Melrose Park, Illinois, 60160
- Recruiting
Site #: 8400003
New Orleans, Louisiana, 70115
- Recruiting
Site #: 8400004
Omaha, Nebraska, 68114
- Recruiting
Site #: 8400021
Omaha, Nebraska, 68134
- Recruiting
Site #: 8400007
Philadelphia, Pennsylvania, 19107
- Recruiting
Site #: 8400013
Richmond, Virginia, 23226
- Recruiting
Site #: 8400024
Rockville, Maryland, 20854
- Recruiting
Site #: 8400019
Sioux City, Iowa, 51106
- Recruiting
Site #: 8400012
Southfield, Michigan, 48076
About this study
Official title: A Phase 4 Open-label, Single-arm Study to Evaluate the Safety and Immunogenicity of an Omicron Subvariant-based SARS-CoV-2 Recombinant Spike (rS) Vaccine Adjuvanted With Matrix-M in Participants ≥ 65 Years of Age and Participants 12 Through 64 Years of Age Who Are at Increased Risk for Severe COVID-19 Illness
The purpose of this study is to evaluate the safety and immunogenicity of a single dose of Sanofi's Omicron subvariant-based Nuvaxovid in participants ≥ 65 years of age and participants 12 through 64 years of age who have at least one underlying condition that puts them at increased risk for severe outcomes of COVID-19 and who have been previously vaccinated with a COVID-19 vaccine ≥ 90 days prior to study vaccination.
Study details include:
- The study duration will be approximately 3 months per participant.
- Study intervention will be administered via a single intramuscular (IM) injection into the deltoid muscle on Day 1.
- The visit frequency will be Day 1, Day 9 telephone call, Day 29, and Day 91 telephone call (3-month safety follow-up).
- Conditions
- COVID-19
- Being tested
- Omicron Subvariant-Based SARS-CoV-2 Recombinant Spike Vaccine Adjuvanted With Matrix-M
- Keywords
- NUVAXOVID, COVID-19, SARS-CoV-2 Infection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omicron Subvariant-Based SARS-CoV-2 Recombinant Spike Vaccine Adjuvanted With Matrix-MBiological
Also called Nuvaxovid, NUVAXOVID™
Pharmaceutical form: Sterile suspension for injection Route of administration: Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Nuvaxovid | Experimental | Participants will receive a single intramuscular injection of Nuvaxovid on Day 1 Receives: Biological: Omicron Subvariant-Based SARS-CoV-2 Recombinant Spike Vaccine Adjuvanted With Matrix-M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Fold Rise (GMFR) in pseudovirus neutralizing antibody titers (ID50) against the Omicron subvariant included in the vaccine formulation from pre-vaccination to 28 days post-vaccination.
Superior neutralizing antibody response is defined as a GMFR with a lower bound of the two-sided 95% confidence interval greater than 4.0 within each age cohort.
Measured: Day 1 (pre-vaccination) and Day 29 (28 days after vaccination)
Secondary outcomes (11)
Geometric Mean Titers (GMTs) of Pseudovirus Neutralizing Antibodies Against the Omicron Subvariant Included in the Vaccine Formulation
Pseudovirus neutralizing antibody responses against the Omicron subvariant included in the vaccine formulation will be measured as geometric mean titers (GMTs).
Measured: Day 1 (pre-vaccination) and Day 29 (28 days after vaccination)
Seroresponse Rate (SRR) in Pseudovirus Neutralizing Antibody Titers Against the Omicron Subvariant Used in the Vaccine Formulation
Seroresponse is defined as a pre-vaccination antibody titer below the lower limit of quantitation (LLOQ) and a post-vaccination antibody titer ≥ 4 × LLOQ; at least a 4-fold rise when the pre-vaccination titer is ≥ LLOQ and < 4 × LLOQ; or at least a 2-fold rise when the pre-vaccination titer is ≥ 4 × LLOQ.
Measured: Day 29 (28 days after vaccination)
Presence of Immediate Adverse Events (AEs)
Number of participants reporting immediate adverse events within 30 minutes following study vaccination.
Measured: Within 30 minutes after vaccination on Day 1
Presence of Solicited Injection Site Reactions
Number of participants reporting solicited injection site reactions during the 8-day period including the day of vaccination.
Measured: Day 1 through Day 8
Presence of Solicited Systemic Reactions
Number of participants reporting solicited systemic reactions during the 8-day period including the day of vaccination.
Measured: Day 1 through Day 8
Presence of Unsolicited Adverse Events (AEs)
Number of participants reporting unsolicited adverse events during the 28-day period including the day of vaccination.
Measured: Day 1 through Day 28
Presence of Medically Attended Adverse Events (MAAEs)
Number of participants reporting medically attended adverse events (MAAEs) during the 28-day period including the day of vaccination.
Measured: Day 1 through Day 28
Presence of Related Medically Attended Adverse Events (MAAEs)
Number of participants reporting medically attended adverse events considered related to the study intervention from Day 29 through the end of the study.
Measured: Day 29 through approximately Day 91
Presence of Adverse Events of Special Interest (AESIs)
Number of participants reporting adverse events of special interest (AESIs) throughout the study. Protocol-defined AESIs include anaphylaxis; myocarditis, pericarditis, or myopericarditis; and new onset or worsening of potential immune-mediated disease.
Measured: Day 1 through approximately Day 91
Presence of Serious Adverse Events (SAEs)
Number of participants reporting serious adverse events (SAEs) throughout the study.
Measured: Day 1 through approximately Day 91
Presence of Adverse Events (AEs) Leading to Study Discontinuation
Number of participants reporting adverse events leading to study discontinuation throughout the study.
Measured: Day 1 through approximately Day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Oct 2026
- Primary completion26 Nov 2026 (estimated)
- Study completion27 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations Study Director, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861542
- Sponsor's protocol ID
- VBV19172
- Other IDs
- U1111-1339-2475
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Open-label, Single-arm Study to Evaluate the Safety and Immunogenicity of an Omicron Subvariant-based SARS-CoV-2 Recombinant Spike (rS) Vaccine Adjuvanted With Matrix-M in Participants ≥ 65 Years of Age and Participants 12 Through 64 Years of Age Who Are at Increased Risk for Severe COVID-19 Illness
- ClinicalTrials.gov ID
- NCT07861542
- Acronym / sponsor ID
- VBV19172
- Conditions
- COVID-19
- Keywords
- NUVAXOVID, COVID-19, SARS-CoV-2 Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 26 Nov 2026 (estimated)
- Study completion
- 27 Jan 2027 (estimated)
- First posted
- 6 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 evaluate the safety and immunogenicity of a single dose of Sanofi's Omicron subvariant-based Nuvaxovid in participants ≥ 65 years of age and participants 12 through 64 years of age who have at least one underlying condition that puts them at increased risk for severe outcomes of COVID-19 and who have been previously vaccinated with a COVID-19 vaccine ≥ 90 days prior to study vaccination.
Study details include:
- The study duration will be approximately 3 months per participant.
- Study intervention will be administered via a single intramuscular (IM) injection into the deltoid muscle on Day 1.
- The visit frequency will be Day 1, Day 9 telephone call, Day 29, and Day 91 telephone call (3-month safety follow-up).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nuvaxovid | Experimental | Biological: Omicron Subvariant-Based SARS-CoV-2 Recombinant Spike Vaccine Adjuvanted With Matrix-MParticipants will receive a single intramuscular injection of Nuvaxovid on Day 1 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Participants ≥ 65 years of age, or participants 12 through 64 years of age who have at least 1 underlying condition that puts them at increased risk for severe outcomes from COVID-19 at the time of study vaccination.
- Previously vaccinated with a COVID-19 vaccine, with the last dose administered ≥ 90 days prior to study vaccination.
- Participants must not be pregnant or breastfeeding. Participants of childbearing potential must have a negative highly sensitive pregnancy test at enrollment and must agree to use an effective method of contraception or remain abstinent from ≥ 4 weeks before study vaccination through ≥ 4 weeks after vaccination.
Key exclusion criteria (8 listed)
- Known or suspected congenital or acquired immunodeficiency; receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the past 6 months; or long-term use of systemic corticosteroids.
- History of virologically confirmed SARS-CoV-2 infection within 90 days before study vaccination.
- Known systemic hypersensitivity to any component of the study intervention or a history of a life-threatening reaction to the study intervention or to a product containing the same substances.
- Prior history of myocarditis, pericarditis, or myopericarditis.
- Receipt of any vaccine within 28 days before study vaccination, except for influenza vaccine, which may be administered at least 14 days before study vaccination.
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 |
|---|---|---|
| Omicron Subvariant-Based SARS-CoV-2 Recombinant Spike Vaccine Adjuvanted With Matrix-MAlso: Nuvaxovid, NUVAXOVID™Pharmaceutical form: Sterile suspension for injection Route of administration: Intramuscular injection | Biological | Nuvaxovid |
Primary outcome
Geometric Mean Fold Rise (GMFR) in pseudovirus neutralizing antibody titers (ID50) against the Omicron subvariant included in the vaccine formulation from pre-vaccination to 28 days post-vaccination.
Time frame: Day 1 (pre-vaccination) and Day 29 (28 days after vaccination)
Superior neutralizing antibody response is defined as a GMFR with a lower bound of the two-sided 95% confidence interval greater than 4.0 within each age cohort.
11 secondary outcomes
Geometric Mean Titers (GMTs) of Pseudovirus Neutralizing Antibodies Against the Omicron Subvariant Included in the Vaccine Formulation
Time frame: Day 1 (pre-vaccination) and Day 29 (28 days after vaccination)
Seroresponse Rate (SRR) in Pseudovirus Neutralizing Antibody Titers Against the Omicron Subvariant Used in the Vaccine Formulation
Time frame: Day 29 (28 days after vaccination)
Presence of Immediate Adverse Events (AEs)
Time frame: Within 30 minutes after vaccination on Day 1
Presence of Solicited Injection Site Reactions
Time frame: Day 1 through Day 8
Presence of Solicited Systemic Reactions
Time frame: Day 1 through Day 8
Presence of Unsolicited Adverse Events (AEs)
Time frame: Day 1 through Day 28
Presence of Medically Attended Adverse Events (MAAEs)
Time frame: Day 1 through Day 28
Presence of Related Medically Attended Adverse Events (MAAEs)
Time frame: Day 29 through approximately Day 91
Presence of Adverse Events of Special Interest (AESIs)
Time frame: Day 1 through approximately Day 91
Presence of Serious Adverse Events (SAEs)
Time frame: Day 1 through approximately Day 91
Presence of Adverse Events (AEs) Leading to Study Discontinuation
Time frame: Day 1 through approximately Day 91
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 15 Oct 2026.
- VBV19172 Plain Language Results SummaryLink 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
Related trials for COVID-19
RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Motivational Interviewing Intervention for Families With Overweight and Obesity
Obesity & Overweight
Active, not recruiting
Lupus Education Alliance Program
Systemic Lupus Erythematosus, COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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 number for US & Canada) contact
Clinical Sciences & Operations Study Director study director
Sanofi
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omicron Subvariant-Based SARS-CoV-2 Recombinant Spike Vaccine Adjuvanted With Matrix-M in people with COVID-19, run by Sanofi at 20 sites in United States.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 number for US & Canada) (800-633-1610 ext. 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?
Geometric Mean Fold Rise (GMFR) in pseudovirus neutralizing antibody titers (ID50) against the Omicron subvariant included in the vaccine formulation from pre-vaccination to 28 days post-vaccination. (time frame: Day 1 (pre-vaccination) and Day 29 (28 days after vaccination)). 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 15 Oct 2026.