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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
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
IIV-HD (standalone)
Pharmaceutical form: Suspension Route of administration: Intramuscular injection
NVXC19 (EU licensed, standalone)
Pharmaceutical form: Dispersion Route of administration: Intramuscular injection
IIV-HD + NVXC19 combination
Pharmaceutical form: Suspension Route of administration: Intramuscular injection
Placebo, normal saline
Pharmaceutical form: Solution Route of administration: Intramuscular injection