mRNA-1083 / Moderna - LARVOL DELTA

Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=2457 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

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

Health-Related Quality of Life Following Administration of Influenza and COVID-19 Combination Vaccine in Older Adults: Results From a Phase 3 Randomized Controlled Trial (ISPOR-EU 2025) - P3 | "This study evaluated short-term HRQoL changes within the first 7 days post-vaccination in older adults (≥65 years), including subgroups aged 65-74 and ≥75 years, in a Phase 3, randomized, observer-blind, active-controlled trial (NCT06097273). Participants (1:1 randomization) received either mRNA-1083 with placebo or co-administered Fluzone High-Dose Quadrivalent (HD-IIV4) and mRNA-1273 (Spikevax). mRNA-1083 was associated with a transient and minor decrements in participants' HRQoL, which were not meaningful. These findings are consistent with other currently licensed vaccines and support the tolerability of mRNA-1083 from a patient-reported outcomes perspective."

Clinical • HEOR • P3 data • Herpes Zoster • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Varicella Zoster

A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age (clinicaltrials.gov) - P2 | N=1320 | Completed | Sponsor: ModernaTX, Inc. | Recruiting ➔ Completed

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

A Clinical Study to Investigate the Safety and Immunogenicity in Relation to Product Attributes of mRNA-1083 (Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] and Influenza Vaccine) (clinicaltrials.gov) - P2 | N=932 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

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

Immunogenicity and Reactogenicity of an mRNA-Based Seasonal Influenza and SARS-CoV-2 Multicomponent Vaccine (mRNA-1083) in Adults ≥65 Years With Comorbidities (ESWI 2025) - No abstract available

Clinical • Infectious Disease • Influenza • Novel Coronavirus Disease

Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=2457 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Comparing Moderna's mRNA-1083 and Pfizer's dual-target mRNA vaccines for influenza and COVID-19. (PubMed, NPJ Vaccines) - "Both utilize mRNA technology, demonstrating strong immunogenicity and favorable safety profiles. Moderna's mRNA-1083 showed superior immune responses, while Pfizer's mRNA-1020/1030 performed well but was slightly less effective against influenza B. These vaccines simplify immunization strategies, enhance protection, and emphasize the need for global vaccine equity to prevent future outbreaks."

Journal • Review • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years: A Randomized Clinical Trial. (PubMed, JAMA) - P3 | "Participants in 2 age cohorts (≥65 years and 50-64 years) were randomly assigned (1:1) to receive mRNA-1083 plus placebo or coadministered licensed quadrivalent seasonal influenza (≥65 years: high-dose quadrivalent inactivated influenza vaccine [HD-IIV4]; 50-64 years: standard-dose IIV4 [SD-IIV4]) and COVID-19 (all ages: mRNA-1273) vaccines. In this study, mRNA-1083 met noninferiority criteria and induced higher immune responses than recommended standard care influenza (standard and high dose) and COVID-19 vaccines against all 4 influenza strains (among those ages 50-64 y), the 3 clinically relevant influenza strains (among those aged ≥65 y), and SARS-CoV-2 (all ages), with an acceptable tolerability and safety profile. ClinicalTrials.gov Identifier: NCT06097273."

Clinical • Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age (clinicaltrials.gov) - P2 | N=1300 | Recruiting | Sponsor: ModernaTX, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine in healthy adults: a phase 1/2 trial. (PubMed, Nat Med) - P1/2 | "mRNA-1083 induced immune responses against influenza and SARS-CoV-2 that were, in general, similar to or higher than those achieved with licensed quadrivalent influenza (standard or high dose) and SARS-CoV-2 (bivalent mRNA-1273) vaccines. These data support ongoing phase 3 evaluation of the mRNA-1083 vaccine. ClinicalTrials.gov registration: NCT05827926 ."

Journal • P1/2 data • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=2450 | Recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Aug 2026 ➔ Dec 2025 | Trial primary completion date: Aug 2026 ➔ Dec 2025

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

A Clinical Study to Investigate the Safety and Immunogenicity in Relation to Product Attributes of mRNA-1083 (Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] and Influenza Vaccine) (clinicaltrials.gov) - P2 | N=900 | Active, not recruiting | Sponsor: ModernaTX, Inc. | N=619 ➔ 900 | Trial completion date: Feb 2025 ➔ Sep 2025 | Trial primary completion date: Feb 2025 ➔ Sep 2025

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

A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age (clinicaltrials.gov) - P2 | N=1300 | Not yet recruiting | Sponsor: ModernaTX, Inc.

New P2 trial • 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=1763 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

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

Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=2450 | Recruiting | Sponsor: ModernaTX, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=2450 | Not yet recruiting | Sponsor: ModernaTX, Inc.

New P3 trial • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

PHASE 3 SAFETY AND IMMUNOGENICITY OF AN MRNA-BASED SEASONAL INFLUENZA AND SARS-COV-2 MULTICOMPONENT VACCINE (MRNA-1083) COMPARED WITH CO-ADMINISTERED LICENSED VACCINES IN ADULTS ≥50 YEARS OLD (ISIRV-OPTIONS XII 2024) - No abstract available

Clinical • Late-breaking abstract • P3 data • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Development of mRNA-1083, a multi-component Influenza/COVID-19 vaccine candidate (V-Congress 2024) - No abstract available

Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

A Clinical Study to Investigate the Safety and Immunogenicity in Relation to Product Attributes of mRNA-1083 (Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] and Influenza Vaccine) (clinicaltrials.gov) - P2 | N=619 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

A Clinical Study to Investigate the Safety and Immunogenicity in Relation to Product Attributes of mRNA-1083 (Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] and Influenza Vaccine) (clinicaltrials.gov) - P2 | N=600 | Recruiting | Sponsor: ModernaTX, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

A Clinical Study to Investigate the Safety and Immunogenicity in Relation to Product Attributes of mRNA-1083 (Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] and Influenza Vaccine) (clinicaltrials.gov) - P2 | N=600 | Not yet recruiting | Sponsor: ModernaTX, Inc.

New P2 trial • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age (clinicaltrials.gov) - P3 | N=8075 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • 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=1763 | Active, not recruiting | Sponsor: ModernaTX, Inc. | N=1231 ➔ 1763

Enrollment change • 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. | 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-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age (clinicaltrials.gov) - P3 | N=8075 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2023 ➔ May 2024

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