A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age

Moderna

Status and phase: Completed; Phase 3

Conditions: Respiratory Syncytial Virus

Treatments: Biological: Fluzone HD; Biological: mRNA-1345; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06060457

mRNA-1345-P304

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and immunogenicity of mRNA-1345 RSV vaccine when coadministered with a high dose (HD) quadrivalent seasonal influenza vaccine (Fluzone HD) in adults ≥65 years of age. The study will examine the impact of Fluzone HD on the immune response to mRNA-1345 against RSV-A and RSV-B, as well as the impact of mRNA-1345 on the immune response to Fluzone HD against 4 vaccine-matched Influenza A and B strains.

Enrollment: 1,900 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 Day 1 due to treatment failure or toxicity,
  • Absence of serious or significant medical events within 30 days of Day 1, and
  • Absence of known, current, and life-limiting diagnoses which, in the opinion of the Investigator, would make completion of the protocol unlikely.

• A participant assigned female at birth is eligible to participate if they are postmenopausal or not a person of childbearing potential.

Key Exclusion Criteria:

• Close contact with someone with laboratory-confirmed influenza and/or RSV infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to Day 1.
• Reported history of congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.
• Participant has tested positive for influenza or RSV by local health authority-approved testing methods ≤6 months prior to Day 1.
• Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections (Day 1 and Day 22) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study injections.
• Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine ≤6 months prior to Day 1.
• Participant has received any RSV vaccine (authorized/approved by local health agency or investigational) prior to Day 1.

Note: Other protocol-defined inclusion and/or exclusion criteria may apply.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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1,900 participants in 2 patient groups

Fluzone HD + mRNA-1345

Experimental group

Description:

Participants will receive Fluzone HD + mRNA-1345 by intramuscular (IM) injection on Day 1 followed by placebo by IM injection on Day 22.

Treatment:

Biological: Placebo

Biological: mRNA-1345

Biological: Fluzone HD

Fluzone HD Followed by mRNA-1345

Experimental group

Description:

Participants will receive Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.

Treatment:

Biological: Placebo

Biological: mRNA-1345

Biological: Fluzone HD