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

StatusNot Yet Recruiting
PhasePhase 3
SponsorSanofi
Started

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Record History

  1. Study First Submitted
Sanofi
286 trials monitored
See 13 trials at risk
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
Trial Details
NCT Number NCT07890454
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Immunization, Healthy Volunteers, COVID-19 Immunization, Influenza Immunization
Related terms Influenza, Human
Enrollment 6,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov