Skip to content

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526221-18-00
Enrollment
2735
Registered
2026-10-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Influenza

Brief summary

Antibody titers against for each of the 3 influenza vaccine strains (in a subset of participants), Antibody titers against SARS-CoV-2 specific variant (in a subset of participants)

Detailed description

Presence of solicited injection site reactions for 8 days, including the day of vaccination (Main subset of participants), Presence of solicited systemic reactions for 8 days, including the day of vaccination (Main subset of participants), Presence of immediate adverse events after vaccination, Presence of unsolicited adverse events, Presence of all medically attended adverse events, Presence of related medically attended adverse events linked to predefined potential immune-mediated diseases, Presence of all adverse events of special interest, Presence of all serious adverse events, Presence of related serious adverse events, Presence of related adverse events of special interest, Presence of related medical attended adverse events linked to predefined potential immune-mediated diseases that meet the criteria for serious adverse events, Presence of adverse events leading to study discontinuation throughout the study, Influenza seroconversion status after vaccination for each of the 3 influenza vaccine strains, SARS-CoV-2 seroresponse status after vaccination, 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), 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), Neutralizing antibody titer ≥ 10 (1/dil) against each of the 3 influenza vaccine strains after vaccination (in a subset of participants), Neutralizing antibody titer ≥ 20 (1/dil) against each of the 3 influenza vaccine strains after vaccination (in a subset of participants), Neutralizing antibody titer ≥ 40 (1/dil) against each of the 3 vaccine strains after vaccination (in a subset of participants), Neutralizing antibody titer ≥ 80 (1/dil) against each of the 3 influenza vaccine strains after vaccination (in a subset of participants), Fold increase in neutralization test antibody titer against each of the 3 influenza vaccine strains after vaccination (in a subset of participants) - ≥ 2-fold rise from Day 01 to Day 29, Fold increase in neutralization test antibody titer against each of the 3 influenza vaccine strains after vaccination (in a subset of participants) - ≥ 4-fold rise from Day 01 to Day 29

Interventions

DRUGEfluelda suspension for injection in pre-filled syringe Trivalent influenza vaccine (split virion
DRUGNuvaxovid dispersion for injection COVID-19 Vaccine (recombinant
DRUGadjuvanted)
DRUGFLUZONE-HD (IIV-HD) + Baculo adj COVID19 (NVXC19) admix

Sponsors

Sanofi Vaccines US Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Antibody titers against for each of the 3 influenza vaccine strains (in a subset of participants), Antibody titers against SARS-CoV-2 specific variant (in a subset of participants)—

Secondary

MeasureTime frame
Presence of solicited injection site reactions for 8 days, including the day of vaccination (Main subset of participants), Presence of solicited systemic reactions for 8 days, including the day of vaccination (Main subset of participants), Presence of immediate adverse events after vaccination, Presence of unsolicited adverse events, Presence of all medically attended adverse events, Presence of related medically attended adverse events linked to predefined potential immune-mediated diseases, Presence of all adverse events of special interest, Presence of all serious adverse events, Presence of related serious adverse events, Presence of related adverse events of special interest, Presence of related medical attended adverse events linked to predefined potential immune-mediated diseases that meet the criteria for serious adverse events, Presence of adverse events leading to study discontinuation throughout the study, Influenza seroconversion status after vaccination for each of the 3 i—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 7, 2026