NCT05572658 (ROSE) is a clinical trial of mRNA-1345 in Respiratory Syncytial Virus, sponsored by ModernaTX, Inc..

Who is sponsoring NCT05572658?

NCT05572658 is sponsored by ModernaTX, Inc..

What drugs are being tested in NCT05572658?

Interventions in NCT05572658: mRNA-1345, Placebo.

What condition does NCT05572658 study?

NCT05572658 studies Respiratory Syncytial Virus.

Is NCT05572658 still recruiting?

NCT05572658 is currently completed. Last updated 24 January 2025.

Last reviewed 2025-01-24 · How we verify

NCT05572658: ROSE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study

Completed Last updated 24 January 2025

What this trial tests

trial testing mRNA-1345 in Respiratory Syncytial Virus in 10,994 participants. Completed in 30 September 2023.

Timeline

15 September 2022

Primary endpoint
30 September 2023

30 September 2023

Quick facts

Lead sponsor	ModernaTX, Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	10,994
Start date	15 September 2022
Primary completion	30 September 2023
Estimated completion	30 September 2023
Sites	109 locations across United States

Drugs / interventions tested

mRNA-1345 — full drug profile →
Placebo

Conditions studied

Respiratory Syncytial Virus — all drugs for Respiratory Syncytial Virus →

Sponsor

ModernaTX, Inc. — full company profile →

Who can join

60 and older, any sex, with Respiratory Syncytial Virus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main goal of this observational study is to describe the health and economic outcomes associated with use of the Moderna mRNA-1345 vaccine.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

mRNA vaccines in disease prevention and treatment.
Zhang G, Tang T, Chen Y, Huang X, et al · · 2023 · cited 148× · PMID 37726283 · DOI 10.1038/s41392-023-01579-1
Respiratory Syncytial Virus Vaccines: A Review of the Candidates and the Approved Vaccines.
Topalidou X, Kalergis AM, Papazisis G. · · 2023 · cited 84× · PMID 37887775 · DOI 10.3390/pathogens12101259
Clinical Trials With Pragmatic Elements: A Review of Use Cases and Real-World Data Utilization.
Su L, Chen L, Betigeri S, Dreyer N, et al · · 2025 · cited 3× · PMID 40827586 · DOI 10.1002/cpt.70033

Verify or expand the search:

Other trials of mRNA-1345

Trials testing the same drug.

NCT07117487 — A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in · Phase 3 · active not recruiting
NCT06143046 — A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated M · Phase 2 · active not recruiting
NCT06097299 — A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High R · Phase 2 · completed
NCT06067230 — A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in · Phase 3 · active not recruiting
NCT06060457 — A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), · Phase 3 · completed

Other recruiting trials for Respiratory Syncytial Virus

Currently open trials in the same condition.

NCT07200206 — A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea · recruiting
NCT07289542 — Phase II Clinical Trial of Lyophilized Respiratory Syncytial Virus mRNA Vaccine in Adults Aged 50 Years or Above · Phase 2 · active not recruiting
NCT07122661 — STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in H · active not recruiting
NCT07117487 — A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in · Phase 3 · active not recruiting
NCT07289503 — Phase I Clinical Trial of Lyophilized Respiratory Syncytial Virus mRNA Vaccine in Adults Aged 18 Years or Above · Phase 1 · active not recruiting

Other ModernaTX, Inc. trials

Trials by the same sponsor.

NCT07496450 — A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults · Phase 3 · recruiting
NCT07478952 — A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189 in Healthy Adults 18 to 30 Years of Age · Phase 1 · recruiting
NCT07266558 — A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without Hig · Phase 4 · recruiting
NCT07116616 — A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 1, PHASE2 · recruiting
NCT07117487 — A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in · Phase 3 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05572658 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ModernaTX, Inc.
Last refreshed: 24 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05572658.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing