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A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age

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Moderna

Status and phase

Active, not recruiting
Phase 3
Phase 2

Conditions

Respiratory Syncytial Virus

Treatments

Drug: Placebo
Drug: mRNA-1345

Study type

Interventional

Funder types

Industry

Identifiers

NCT05127434
mRNA-1345-P301

Details and patient eligibility

About

The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months.

The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.

Full description

The study will be conducted in 2 phases: Phase 2 and Phase 3. In the Part A Phase 2 segment, up to 2,000 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio.

In the Part A Phase 3 segment, approximately 35,000 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio.

In the Part B substudy, 1500 participants who received a dose of mRNA-1345 in Part A Phase 3 will be randomly assigned in a 2:1 randomization ratio to receive a single BD injection of either mRNA-1345 at the selected dose or placebo.

Enrollment

36,814 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria (Part A):

  • Adults ≥ 60 years of age who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses (including chronic heart failure [CHF] and chronic obstructive pulmonary disease [COPD]), but should be medically stable
  • Body mass index from ≥18 kilograms (kg)/square meter (m^2) to ≤35 kg/m^2

Key Inclusion Criteria (Part B):

  • Randomized to and were subsequently vaccinated with the mRNA-1345 study injection in Part A at least 21 months prior to Screening.

Key Exclusion Criteria (Part A):

  • Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of the Day 1 study injection.
  • Current participation in research involving receipt of any investigational RSV product
  • History of a serious reaction to any prior vaccination or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
  • Received or plans to receive any non-study vaccine within 28 days before or after the Day 1 study injection.

Key Exclusion Criteria (Part B):

  • Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of BD study injection (BD Day 1).
  • History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
  • Received or plans to receive any non-study vaccine (including authorized or approved vaccines for the prevention of coronavirus disease 2019 (COVID-19) regardless of type of vaccine) within 14 days before or after the BD Day 1 study injection.
  • Received or plans to receive any commercial RSV vaccination at any time prior to BD study injection (BD Day 1) or during the substudy.

Other inclusion and/or exclusion criteria may apply.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

36,814 participants in 3 patient groups

mRNA-1345
Experimental group
Description:
Single injection of mRNA-1345 on Day 1.
Treatment:
Drug: mRNA-1345
Placebo
Experimental group
Description:
Single injection of mRNA-1345 matching-placebo on Day 1.
Treatment:
Drug: Placebo
mRNA-1345 BD
Experimental group
Description:
Single injection of mRNA-1345 on BD Day 1.
Treatment:
Drug: mRNA-1345

Trial contacts and locations

271

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Central trial contact

Moderna Clinical Trials Support Center

Data sourced from clinicaltrials.gov

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