NCT06585241

A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,144 (estimated)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the immunogenicity and safety of mRNA COVID-19 variant-containing vaccine formulations against the vaccine-matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

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-1273 COVID-19 vaccine. As different variant-containing vaccine formulations will be evaluated, each study intervention will be described in the subprotocol. For each evaluation of an updated variant vaccine or age group, a new subprotocol will be generated. Reported outcome measures are based upon master protocol. Not all reported outcome measures may be applicable to each subprotocol.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1273 Variant-containing Formulation	Sterile liquid for injection

Timeline

• Start date: 2024-09-09
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-09-05
• Last updated: 2026-03-27

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study