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

Phase 1/2 randomized, observer-blind clinical trial of a first-generation, mRNA-based vaccine against seasonal influenza and COVID-19 in healthy adults. (PubMed, Hum Vaccin Immunother) - P1/2 | "Systems serology analysis indicated that mRNA-1073 induced robust, balanced antibody responses with comparable immune profiles to mRNA-1010 + mRNA-1273. mRNA-1073 had an acceptable safety profile and elicited durable immune responses against all vaccine-matched influenza and SARS-CoV-2 strains, supporting ongoing evaluations of mRNA-based multicomponent vaccines that simultaneously protect against seasonal influenza and COVID-19 in a single dose.Registration: ClinicalTrials.gov identifier: NCT05375838 (https://clinicaltrials.gov/study/NCT05375838)."

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

An mRNA influenza vaccine induces immunity comparable to an adjuvanted vaccine in a randomized trial. (PubMed, NPJ Vaccines) - P1 | "mRNA-1010 and FLUAD generated strong HA-specific CD4+ T-cell responses; a trend toward higher CD8+ T-cell responses was observed in mRNA-1010 recipients compared with FLUAD recipients for two of the four strains. These findings support the potential of the mRNA platform for seasonal influenza vaccination."

Journal • Infectious Disease • Influenza • Respiratory Diseases • CD4 • CD8

Moderna Announces Global Regulatory Submissions for Its Investigational Seasonal Influenza Vaccine (Yahoo Finance) - "The Company has filed for marketing authorization with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, and the Therapeutic Goods Administration (TGA) in Australia....The regulatory applications are based on positive data from multiple Phase 3 studies."

Filing • Influenza

mRNA-1010 influenza vaccine elicits distinct and enhanced humoral immunity compared to adjuvanted inactivated vaccines. (PubMed, NPJ Vaccines) - P1 | "However, mRNA-1010 generated stronger Fc-receptor engaging antibodies, faster and completed functional humoral maturation, broader HA-specific binding antibodies, enhanced NK cell activating antibodies to two of the vaccine antigens, and higher HA-specific neutrophil activating antibodies across all vaccine HA antigens. Findings suggest that mRNA vaccination may elicit distinct Fab and Fc responses that may improve viral control and clearance."

Journal • Infectious Disease • Influenza • Respiratory Diseases

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