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OpenTrials
Completed

NCT Number: NCT07117487

A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in Adult Participants ≥60 Years of Age

The purpose of this study is to evaluate safety, tolerability and immunogenicity of mRNA-1345 in participants who have been previously vaccinated with either Arexvy or Abrysvo at least 12 months prior to enrollment, are medically stable and aged ≥60 years.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Velocity Clinical Research, Denver, Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by:
  • Absence of changes in medical therapy within 60 days of Visit 1 due to treatment failure or toxicity.
  • Absence of serious or significant medical events within 30 days of Visit 1.
  • Absence of known, current, and life-limiting diagnoses which, in the opinion of the Investigator, would make completion of the protocol unlikely.
  • Participant has received a single dose of Arexvy or Abrysvo at least 12 months prior to Visit 1. Participants must provide proof of RSV vaccination status (including brand and date received) prior to enrollment.

Key Exclusion Criteria:

  • Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤14 days prior to study injection (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 14 days after the study injection. Nonstudy vaccination(s) should not be delayed.
  • Prior participation in research involving receipt of any investigational RSV product (drug/biologic).
  • Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to Visit 1 or plans to receive them during the study.

Other protocol-specified inclusion and/or exclusion criteria may apply.

Treatment and study plan

mRNA-1345

Biological

Suspension for injection

Primary outcomes

  1. Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

    Time frame: Day 1 up to Day 7 (7 days post-injection)

  2. Number of Participants with Unsolicited Adverse Events (AEs)

    Time frame: Day 1 up to Day 28 (28 days post-injection)

  3. Number of Participants with Medically Attended AEs (MAAEs), Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation

    Time frame: Day 1 up to Day 181 (End of study)

  4. Geometric Mean Titer (GMT) of Serum RSV-A Neutralizing Antibodies (Abs) at Day 29

    Time frame: Day 29

  5. GMT of Serum RSV-B Neutralizing Abs at Day 29

    Time frame: Day 29

Secondary outcomes

  1. GMT of Serum RSV-A Neutralizing Abs

    Time frame: Day 1 up to Day 181 (End of study)

  2. Geometric Mean Fold Rise (GMFR) of Serum RSV-A Neutralizing Abs

    Time frame: Day 181

  3. GMT of Serum RSV-B Neutralizing Abs

    Time frame: Day 1 up to Day 181 (End of study)

  4. GMFR of Serum RSV-B Neutralizing Abs

    Time frame: Day 181

  5. Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs

    Time frame: Day 181

  6. Percentage of Participants With Seroresponse in RSV-B Neutralizing Abs

    Time frame: Day 181

  7. Percentage of Participants With ≥2-fold Increase From Baseline in RSV-A Neutralizing Ab Titers

    Time frame: Day 181

  8. Percentage of Participants With ≥2-fold Increase From Baseline in RSV-B Neutralizing Ab Titers

    Time frame: Day 181

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

A Phase 3 Open-label Study to Evaluate Safety, Tolerability, and Immunogenicity of Revaccination With mRNA-1345 at Least 12 Months Following a Primary Dose of a Licensed Protein Subunit RSV Vaccine in Adult Participants ≥60 Years of Age

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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