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NOT YET RECRUITING
NCT07890454
PHASE3

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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. 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

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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6000

Start Date

2026-11-09

Completion Date

2027-12-28

Last Updated

2026-10-22

Healthy Volunteers

Yes

Interventions

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

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