mRNA-1283.222 / Moderna - LARVOL DELTA

Cell-Mediated Immunity of mRNA-1283 Vaccine Encoding SARS-CoV-2 Spike Receptor-Binding and N-Terminal Domains in Preclinical and Clinical Studies. (PubMed, J Infect Dis) - P2 | "In preclinical and clinical studies, mRNA-1283 induced T-cell responses similar to mRNA-1273."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8

Effectiveness, Comparative Effectiveness, and Harms of COVID-19 Vaccines in Adults Who Are Not Pregnant or Immunocompromised: A Rapid Review for the American College of Physicians. (PubMed, Ann Intern Med) - "The mRNA-1283.222 bivalent vaccine probably results in no difference in all-cause mortality or serious adverse events compared with mRNA-1273.222 in adults of all ages. American College of Physicians. (PROSPERO: CRD420251136017)."

HEOR • Journal • Review • Cardiovascular • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

Efficacy, immunogenicity, and safety of a next-generation mRNA-1283 COVID-19 vaccine compared with the mRNA-1273 vaccine (NextCOVE): results from a phase 3, randomised, observer-blind, active-controlled trial. (PubMed, Lancet Infect Dis) - P3 | "mRNA-1283 was well-tolerated. The rVE and immunogenicity non-inferiority criteria were met, with higher antibody responses for mRNA-1283 versus mRNA-1273. The potential clinical benefit of mRNA-1283 versus mRNA-1273 needs to be confirmed in post-marketing evaluation."

Journal • P3 data • Cardiovascular • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

NextCOVE: A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19 (clinicaltrials.gov) - P3 | N=14246 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

NextCOVE: A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19 (clinicaltrials.gov) - P3 | N=14246 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Aug 2024 ➔ Apr 2025 | Trial primary completion date: Aug 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults (clinicaltrials.gov) - P1/2 | N=1231 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Dec 2023 ➔ Nov 2024 | Trial primary completion date: Dec 2023 ➔ Nov 2024

Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults (clinicaltrials.gov) - P1/2 | N=1231 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Aug 2023 ➔ Dec 2023

Enrollment closed • Trial primary completion date • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

NextCOVE: A Study of mRNA-1283.222 Injection Compared With mRNA-1273.222 Injection in Participants ≥12 Years of Age to Prevent COVID-19 (clinicaltrials.gov) - P3 | N=11471 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Aug 2023 ➔ Aug 2024

Enrollment closed • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults (clinicaltrials.gov) - P1/2 | N=1224 | Recruiting | Sponsor: ModernaTX, Inc.

New P1/2 trial • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

NextCOVE: A Study of mRNA-1283.222 Injection Compared With mRNA-1273.222 Injection in Participants ≥12 Years of Age to Prevent COVID-19 (clinicaltrials.gov) - P3 | N=8472 | Recruiting | Sponsor: ModernaTX, Inc.

New P3 trial • Infectious Disease • Novel Coronavirus Disease