Trial · NCT07890454
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
NCT07890454, Phase 3, Not yet recruiting, Sanofi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT07890454. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07890454
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT07890454
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 6,000 participants, estimated
- Lead sponsor
- Sanofi
- Conditions
- Immunization, Healthy Volunteers, COVID-19 Immunization, Influenza Immunization
- Interventions
- IIV-HD (standalone), NVXC19 (EU licensed, standalone), IIV-HD + NVXC19 combination, Placebo, normal saline
- First posted
- 2026-10-22
- Last updated
- 2026-10-22
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Antibody titers against for each of the 3 influenza vaccine strains(in a subset of participants) | At Day 28 after vaccination | Geometric mean (GMT) of antibody titers measured by hemagglutination inhibition (HAI) |
| Primary | Antibody titers against SARS-CoV-2 specific variant(in a subset of participants) | At Day 28 after vaccination | Geometric mean (GMT) of antibody titers measured by pseudovirus neutralization test (PNT) |
| Secondary | Presence of solicited injection site reactions for 8 days, including the day of vaccination (Main subset of participants) | 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) |
| Secondary | Presence of solicited systemic reactions for 8 days, including the day of vaccination (Main subset of participants) | 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) |
| Secondary | Presence of immediate adverse events after vaccination | 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 |
| Secondary | Presence of unsolicited adverse events | Up to 28 days after vaccination | Number of participants with unsolicited adverse events (AEs) for 28 days, including the day of vaccination |
| Secondary | Presence of all medically attended adverse events | Up to 180 days after vaccination | Number of participants with medical attended adverse events (MAAEs) for 180 days, including the day of vaccination |
| Secondary | Presence of related medically attended adverse events linked to predefined potential immune-mediated diseases | 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 |
| Secondary | Presence of all adverse events of special interest | Up to 180 days after vaccination | Number of participants with adverse events of special interest (AESIs) for 180 days, including the day of vaccination |
| Secondary | Presence of all serious adverse events | Up to 180 days after vaccination | Number of participants with serious adverse events (SAEs) for 180 days, including the day of vaccination |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07890454
GET https://conductscience.org/api/trials/v1/NCT07890454/registered?page=2