mRNA-1365 / Moderna - LARVOL DELTA

A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults (clinicaltrials.gov) - P1 | N=375 | Recruiting | Sponsor: ModernaTX, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults (clinicaltrials.gov) - P1 | N=375 | Not yet recruiting | Sponsor: ModernaTX, Inc.

New P1 trial • Respiratory Diseases • Respiratory Syncytial Virus Infections

mRNA-1365-P101: A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months (clinicaltrials.gov) - P1 | N=186 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Sep 2026 ➔ Aug 2029 | Trial primary completion date: Aug 2026 ➔ Aug 2029

Trial completion date • Trial primary completion date • Respiratory Diseases

mRNA-1365-P101: A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months (clinicaltrials.gov) - P1 | N=186 | Active, not recruiting | Sponsor: ModernaTX, Inc. | N=310 ➔ 186

Enrollment change • Respiratory Diseases

SAFETY AND IMMUNOGENICITY OF INVESTIGATIONAL MRNA-BASED RSV AND RSV/HMPV VACCINES IN CHILDREN 5 TO 7 MONTHS OF AGE (ESPID 2025) - "Two 15µg doses of mRNA-1345 and mRNA-1365 were immunogenic; however, a potential imbalance in severe/hospitalised RSV/hMPV-LRTI led to a study pause and cessation of further dosing or enrolment. Ongoing safety and immunogenicity assessments aim to better understand severe RSV/hMPV-LRTI in in this age group."

Clinical • Late-breaking abstract • Infectious Disease • Respiratory Syncytial Virus Infections

Advancing mRNA vaccines for infectious diseases: key components, innovations, and clinical progress. (PubMed, Essays Biochem) - "The clinical success of BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) has fueled broader applications, including influenza, respiratory syncytial virus (RSV), Zika, and HIV. Notably, mRNA-1345 became the first FDA-approved RSV mRNA vaccine, while self-amplifying RNA and multivalent vaccines are advancing in trials. However, CureVac's CVnCoV failed due to lack of nucleoside modifications, and mRNA-1325 (Zika) showed poor immunogenicity. Additionally, mRNA-1365 (RSV) faced an FDA clinical hold due to safety concerns...Innovations such as lyophilization and selective organ targeting technology are being explored to improve stability extrahepatic delivery. This review examines mRNA vaccine optimization strategies, clinical progress, and challenges, providing insights into future developments in this evolving field."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months (clinicaltrials.gov) - P1 | N=310 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Respiratory Diseases

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months (clinicaltrials.gov) - P1 | N=310 | Recruiting | Sponsor: ModernaTX, Inc. | N=210 ➔ 310

Enrollment change • Respiratory Diseases

REACTOGENICITY AND IMMUNOGENICITY OF MRNA-1345, AN INVESTIGATIONAL RSV VACCINE, AND MRNA-1365, AN INVESTIGATIONAL RSV AND HMPV COMBINATION VACCINE, IN CHILDREN AGED 8 TO 24 MONTHS (ESPID 2024) - P1 | "Conclusions/Learning Points mRNA-1345 and mRNA-1365 were well-tolerated and immunogenic in children aged 8-24 months. Participants will be monitored throughout a complete RSV season before planned enrolment of a 5- to 8-month-old cohort."

Clinical • Late-breaking abstract • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months (clinicaltrials.gov) - P1 | N=210 | Recruiting | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • Respiratory Diseases

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months (clinicaltrials.gov) - P1 | N=210 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Respiratory Diseases

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months (clinicaltrials.gov) - P1 | N=210 | Recruiting | Sponsor: ModernaTX, Inc.

New P1 trial • Respiratory Diseases