seasonal influenza vaccine (mRNA-1010) / Moderna - LARVOL DELTA

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=172 | Completed | Sponsor: ModernaTX, Inc. | Recruiting ➔ Completed | N=325 ➔ 172

Enrollment change • Trial completion • Infectious Disease • Influenza • Respiratory Diseases

mRNA-1010, an mRNA-Based Influenza Vaccine, is Safe and Efficacious in Adults Aged ≥50 Years, Including Individuals at High Risk for Severe Disease (ESWI 2025) - No abstract available

Clinical • Late-breaking abstract • Infectious Disease • Influenza

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=40817 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2026 ➔ Aug 2025 | Trial primary completion date: Jun 2026 ➔ Aug 2025

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

Immunogenicity and safety of mRNA-based seasonal influenza vaccines encoding hemagglutinin and neuraminidase. (PubMed, Nat Commun) - P1/2 | "In this phase 1/2 trial (NCT05333289), healthy adults 18-75 years were randomly assigned to receive different doses of mRNA-1020 or mRNA-1030 (encoding HA and NA at different ratios), mRNA-1010 (encoding HA), or a licensed active comparator (recombinant HA). There were no vaccine-related serious adverse events nor significant associated safety concerns through 181 days. mRNA-1020 and mRNA-1030 elicited high HA-specific immune responses and induced NA-specific immune responses with no additional reactogenicity at equivalent dose levels beyond an mRNA-based, HA-only-containing vaccine."

Clinical • Journal • Fatigue • Infectious Disease • Influenza • Pain • Respiratory Diseases

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=56000 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

Shared clinical and immunologic features of mRNA vaccines: preliminary results from a comparative clinical study. (PubMed, Front Immunol) - P1 | "This ongoing, open-label, phase 1 trial randomized healthy adults (18-75 years) to receive a single dose of mRNA-1273.222 (bivalent COVID-19), mRNA-1345 (RSV), mRNA-1010 (influenza), and FLUAD (active influenza comparator) or 2 or 3 doses of mRNA-1647 (CMV). This suggests that the observed reactogenicity of mRNA vaccines may be related to shared features of the mRNA platform (LNP platform). ClinicalTrials.gov, identifier NCT05397223."

Clinical • Journal • Infectious Disease • Inflammation • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • CCL4 • CCL8 • CD4 • CD8 • CXCL9 • IFNG • IL1R1 • IL2RA • IL6

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=56000 | Recruiting | Sponsor: ModernaTX, Inc. | Trial primary completion date: Dec 2025 ➔ Jun 2026

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

An mRNA-based seasonal influenza vaccine in adults: Results of two phase 3 randomized clinical trials and correlate of protection analysis of hemagglutination inhibition titers. (PubMed, Hum Vaccin Immunother) - P3 | "An analysis of HAI titers as a correlate of protection against influenza infection provided support for its use as a surrogate endpoint for mRNA-1010, similar to licensed influenza vaccines. These findings support further optimization and development of mRNA-1010 against seasonal influenza."

Clinical • Journal • P3 data • Infectious Disease • Influenza • Respiratory Diseases

A phase 3 randomized safety and immunogenicity trial of mRNA-1010 seasonal influenza vaccine in adults. (PubMed, Vaccine) - P3 | "These findings support the potential benefit of mRNA-1010 as a seasonal influenza vaccine."

Journal • P3 data • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=325 | Recruiting | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=325 | Active, not recruiting | Sponsor: ModernaTX, Inc. | N=98 ➔ 325

Enrollment change • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=98 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Aug 2024 ➔ Oct 2025 | Trial primary completion date: Aug 2024 ➔ Oct 2025

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

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=56000 | Recruiting | Sponsor: ModernaTX, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

Six-Month Safety and Immunogenicity of an mRNA-Based Seasonal Influenza Vaccine (mRNA-1010) In Medically Stable Adults: A Randomized, Observer-Blind, Active-Controlled Phase 3 Study (ISIRV-OPTIONS XII 2024) - No abstract available

Clinical • P3 data • Infectious Disease • Influenza • Respiratory Diseases

Safety and Immunogenicity of an mRNA-Based Seasonal Influenza Vaccine (mRNA-1010) Compared to Standard Dose and High Dose Vaccine Comparators (ISIRV-OPTIONS XII 2024) - No abstract available

Clinical • Infectious Disease • Influenza • Respiratory Diseases

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=56000 | Not yet recruiting | Sponsor: ModernaTX, Inc.

New P3 trial • Infectious Disease • Influenza • Respiratory Diseases

Safety and immunogenicity of mRNA-based seasonal influenza vaccines formulated to include multiple A/H3N2 strains with or without the B/Yamagata strain in US adults aged 50-75 years: a phase 1/2, open-label, randomised trial. (PubMed, Lancet Infect Dis) - P1/2 | "These data support the continued clinical development of mRNA-based next-generation seasonal influenza vaccines with broadened influenza A/H3N2 strain coverage."

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

IGNITE P303: Study of mRNA-1010 Seasonal Influenza Vaccine in Adults (clinicaltrials.gov) - P3 | N=8422 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Safety and Immunogenicity of mRNA-1010, an Investigational Seasonal Influenza Vaccine, in Healthy Adults: Final Results From a Phase 1/2 Randomized Trial. (PubMed, J Infect Dis) - P1/2 | "Data support the continued development of mRNA-1010 as a seasonal influenza vaccine."

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

Safety and immunogenicity of an mRNA-based seasonal influenza vaccine (mRNA-1010) in healthy adults (ECCMID 2024) - No abstract available

Clinical • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=98 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Completed ➔ Active, not recruiting | N=68 ➔ 98 | Trial completion date: Jan 2024 ➔ Aug 2024 | Trial primary completion date: Jan 2024 ➔ Aug 2024

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

A Study of Modified mRNA Vaccines in Healthy Adults (clinicaltrials.gov) - P1 | N=308 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Mar 2024 ➔ Feb 2026 | Trial primary completion date: Mar 2024 ➔ Feb 2026

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

A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1045 (Influenza and Respiratory Syncytial Virus [RSV]) or mRNA-1230 (Influenza, RSV, and Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2]) Vaccine in Adults 50 to 75 Years Old (clinicaltrials.gov) - P1 | N=392 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=68 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed | N=250 ➔ 68 | Trial completion date: Jul 2024 ➔ Jan 2024 | Trial primary completion date: Jul 2024 ➔ Jan 2024

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

IGNITE P303: Study of mRNA-1010 Seasonal Influenza Vaccine in Adults (clinicaltrials.gov) - P3 | N=8400 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases