A Study of Modified mRNA Vaccines in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-24

Study Completion Date

2026-02-21

Brief Summary

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The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines.

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Detailed Description

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Conditions

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SARS-CoV-2 Seasonal Influenza Respiratory Syncytial Virus Cytomegalovirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Part 1: mRNA-1345

Participants will receive single intramuscular (IM) injection of mRNA-1345 on Day 1.

Group Type EXPERIMENTAL

mRNA-1345

Intervention Type BIOLOGICAL

Sterile liquid for injection

Part 1: mRNA-1647 2-Dose

Participants will receive single IM injection of mRNA-1647 on Days 1 and 57.

Group Type EXPERIMENTAL

mRNA-1647

Intervention Type BIOLOGICAL

Sterile lyophilized product

Part 1: mRNA-1647 3-Dose

Participants will receive single IM injection of mRNA-1647 on Days 1, 57, and 169.

Group Type EXPERIMENTAL

mRNA-1647

Intervention Type BIOLOGICAL

Sterile lyophilized product

Part 2: mRNA-1273

Participants will receive single IM injection of mRNA-1273 on Day 1

Group Type EXPERIMENTAL

mRNA-1273

Intervention Type BIOLOGICAL

Sterile liquid for injection

Part 2: mRNA-1010

Participants will receive single IM injection of mRNA-1010 on Day 1.

Group Type EXPERIMENTAL

mRNA-1010

Intervention Type BIOLOGICAL

Sterile liquid for injection

Part 2: FLUAD®

Participants will receive single IM injection of FLUAD® on Day 1.

Group Type ACTIVE_COMPARATOR

FLUAD®

Intervention Type BIOLOGICAL

adjuvanted (MF59), inactivated, quadrivalent seasonal influenza vaccine

Interventions

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mRNA-1273

Sterile liquid for injection

Intervention Type BIOLOGICAL

mRNA-1010

Sterile liquid for injection

Intervention Type BIOLOGICAL

mRNA-1345

Sterile liquid for injection

Intervention Type BIOLOGICAL

FLUAD®

adjuvanted (MF59), inactivated, quadrivalent seasonal influenza vaccine

Intervention Type BIOLOGICAL

mRNA-1647

Sterile lyophilized product

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adults 18 to 75 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening. For mRNA-1647 study arms, adults 18 to \<50 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening.
* Body mass index (BMI) of 18 kilograms (kg)/square meter (m\^2) to 35 kg/m\^2 (inclusive) at the screening visit.

Exclusion Criteria

* Participant has had close contact to someone with confirmed SARS-CoV-2, respiratory syncytial virus (RSV), or influenza infection in the past 14 days prior to the screening visit.
* Severe allergic reaction to any component of the FLUAD vaccine (active comparator), including egg protein, or after a previous dose of any influenza vaccine.
* Participant has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to screening (to include any systemic corticosteroids) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
* Participant plans to receive any licensed or authorized vaccine, including COVID-19 influenza vaccines, within 28 days before or after any study injection.
* Participant has received a NH 2021 - 2022 or 2022-2023 seasonal influenza vaccine or any other influenza vaccine, or an experimental RSV or cytomegalovirus (CMV) vaccine, within 6 months prior to study Day 1, and/or has not completed a primary vaccination series for COVID-19.
* Participant has received an authorized or approved COVID-19 vaccine within 4 months prior to Day 1, and/or has not completed a primary vaccination series for COVID-19.
* Participant had a laboratory-confirmed infection with influenza or RSV within 6 months prior to Day 1, or SARS-CoV-2 within 4 months of Day 1. SARS-CoV-2 infection confirmed with self-administered, authorized or approved rapid antigen test is acceptable.
* Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the screening visit or plans to donate blood products during the study.
* Participated in an interventional clinical study within 28 days prior to the screening visit based on the medical history interview or plans to do so while participating in this study until 12 months after their last study vaccination.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes