mRNA-1083 / Moderna - LARVOL DELTA

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

A Study of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age (clinicaltrials.gov) - P3 | N=8000 | Recruiting | Sponsor: ModernaTX, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • 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=8000 | Not yet recruiting | Sponsor: ModernaTX, Inc.

New P3 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=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

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