Phase 4Recruiting

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

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

Sponsor
ModernaTX, Inc. (Industry)
Enrollment
300 planned
Conditions
SARS-CoV-2
Interventions
mRNA-1273; mRNA-1283
Ages
children, adults, older adults
Registry
NCT07863635

Full record on ClinicalTrials.gov

From the registry

The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1283 and mRNA-1273 (variant formulations) within the current epidemiological environment

Primary outcomes

  • Geometric Mean Titer (GMT) on Neutralizing Antibody (nAb) Against Vaccine-matched Variant Formulation
  • Geometric Mean Fold Rise (GMFR) on Neutralizing Antibody (nAb) Against Vaccine-matched Variant Formulation

History

  1. Primary completion expected

  2. Last registry update

  3. Started

  4. Registered