A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age

Conditions

• Respiratory Syncytial Virus

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Placebo — BIOLOGICAL
  0.9% sodium chloride (normal saline) injection
• mRNA-1345 — BIOLOGICAL
  Sterile liquid for injection
• Afluria® Quadrivalent — BIOLOGICAL
  single-dose, pre-filled syringe for injection
• mRNA-1273.214 — BIOLOGICAL
  Sterile liquid for injection

Study Details

The main purposes of Part A of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with a seasonal influenza vaccine (Afluria® Quadrivalent); to evaluate the impact of coadministered influenza vaccine on the immune response to RSV-A; and to evaluate the impact of coadministered RSV vaccine on the immune response to influenza. The main purposes of Part B of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with mRNA-1273.214; to evaluate the effect of coadministered mRNA-1273.214 on the immune response to RSV-A; and to evaluate the effect of coadministered RSV vaccine on the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The main purposes of Part C (single arm, open-label) of this study are to evaluate the safety and tolerability of a booster dose (BD) of mRNA-1345 administered at 1 Year following a primary dose; to evaluate the immune response to RSV-A of a BD of mRNA 1345 administered at 1 Year following a primary dose; and to evaluate the immune response to RSV-B of a BD of mRNA-1345 administered at 1 Year following a primary dose.

Key Dates

First listed

Apr 15, 2022

Start date

Apr 1, 2022

Status verified

Dec 2025

Primary completion

Nov 8, 2024

Completion

Nov 8, 2024

Study Design

Enrollment

3,317 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Part A: mRNA-1345 + Placebo
  Single injection of mRNA-1345 and placebo, administered intramuscularly (IM), one in each arm on Day 1.
• Experimental: Part A: mRNA-1345 + Afluria® Quadrivalent
  Single injection of mRNA-1345 and Afluria® quadrivalent, administered IM, one in each arm on Day 1.
• Active Comparator: Part A: Afluria® Quadrivalent + Placebo
  Single injection of Afluria® quadrivalent and placebo, administered IM, one in each arm on Day 1.
• Experimental: Part B: mRNA-1345 + Placebo
  Single injection of mRNA-1345 and placebo, administered IM, one in each arm on Day 1. An additional injection of mRNA-1273.214, administered on Day 29.
• Experimental: Part B: mRNA-1345 + mRNA-1273.214
  Single injection of mRNA-1345 and mRNA-1273.214, administered IM, one in each arm on Day 1. An additional injection of placebo administered on Day 29.
• Active Comparator: Part B: mRNA-1273.214 + Placebo
  Single injection of mRNA-1273.214 and placebo, administered IM, one in each arm on Day 1. An additional injection of placebo administered on Day 29.
• Experimental: Part C: mRNA-1345
  Single injection of mRNA-1345 administered IM on BD Day 1.

Primary Outcome Measure

Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection [ Time Frame: Within 7 days after Day 1 injection ]

Locations (62)

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