NCT06695130

Study of a Combination Vaccine Comprised of Different Recombinant Spike Antigen Levels of a Matrix-M Adjuvanted Recombinant COVID-19 Vaccine and Recombinant Influenza Vaccine in Adult Participants 50 Years of Age and Older

A Phase 1/2, Parallel, Randomized, Modified Double-blind, Multi-arm Study to Assess the Safety and Immunogenicity of a Combination Vaccine Comprised of Different Recombinant Spike Antigen Levels of a Matrix-M Adjuvanted Recombinant COVID-19 Vaccine and Recombinant Influenza Vaccine in Adult Participants 50 Years of Age and Older

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 980 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

Study VBT00002 is planned to be a Phase 1/2, randomized, modified double-blind, active-controlled, multi-center study to be conducted in approximately 980 adults aged 50 years and older in the United States. The purpose of the study is to assess the safety and immunogenicity of recombinant influenza vaccine (RIV) + adjuvanted recombinant COVID-19 vaccine (rC19) vaccine comprised of RIV combined with different recombinant Spike (rS) antigen levels of rC19 compared to RIV alone, rC19 (dose 1) alone, and RIV and rC19 (dose 1) (coadministered in opposite arms). Placebo will be coadministered in the RIV alone, rC19 (dose 1) alone, and RIV + rC19 study groups to control for the number of injections and to maintain observer blinding. Thus, each participant will receive two injections at enrollment, one in each deltoid muscle. Study details include: * The study duration will be approximately 12 months * Study intervention will be administered via a single intramuscular (IM) injection into the right and left deltoid muscles on Day(D) 01 * Dose escalation with sequential enrollment (sentinel cohort followed by main cohort for a given dose) * The visit frequency for participants will be D01 and D30, and D09-D366 (telephone call) Number of Participants: Approximately 980 participants are expected to be randomized.

Conditions

• COVID-19 Immunization
• Influenza Immunization

Interventions

Type	Name	Description
BIOLOGICAL	RIV (recombinant influenza vaccine)	Influenza, inactivated, split virus or surface antigen
BIOLOGICAL	rC19 (dose 1)	Protein subunit
BIOLOGICAL	RIV + rC19 (dose 1)	RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit
BIOLOGICAL	RIV + rC19 (dose 2)	RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit
BIOLOGICAL	RIV + rC19 (dose 3)	RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit
BIOLOGICAL	RIV + rC19 (dose 4)	RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit
OTHER	Placebo (0.9% NaCl)	Normal saline

Timeline

• Start date: 2024-11-18
• Primary completion: 2026-04-03
• Completion: 2026-04-03
• First posted: 2024-11-19
• Last updated: 2025-05-28

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study