Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-01-01 @ 1:10 AM
Study NCT ID:
NCT07089706
Status:
RECRUITING
Last Update Posted:
2025-10-14
First Post:
2025-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations
Sponsor:
ModernaTX, Inc.
Organization:
Study Overview
Official Title:
A Phase 3b/4, Open-label Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Vaccine Formulations
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: