NCT07089706

A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations

A Phase 3b/4, Open-label Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Vaccine Formulations

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 832 (estimated)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity and safety of the recommended variant-containing formulations of mRNA-1283 COVID-19 vaccine (mNEXSPIKE®) within the current epidemiological environment.

Detailed description

This study uses a master protocol with a generic study design to allow flexibility in evaluating immunogenicity of variant-containing formulations of the mRNA-1283 COVID-19 vaccine. As different variant-containing vaccine formulations will be evaluated, each study intervention (for example, updated mRNA-1283 COVID-19 vaccine) will be described in the subprotocol. For each evaluation of an updated variant vaccine, a new subprotocol will be generated. Subprotocol 01 is a single arm study to evaluate immunogenicity and safety of mRNA-1283 (COVID-19 vaccine) 2025-2026 formula in individuals aged ≥65 years and ≥12 to \<65 years with at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19. The study included Parts A and B. Part A enrollment was discontinued due to addition of Part B to evaluate the safety and immunogenicity of variant-containing mRNA-1283 using a hypothesis driven study endpoint with reactogenicity data collection and longer safety follow up in Part B.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1283.251 Variant-containing Formulation	Sterile liquid for injection

Timeline

• Start date: 2025-07-21
• Primary completion: 2026-05-11
• Completion: 2026-05-11
• First posted: 2025-07-28
• Last updated: 2025-10-14

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study