A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1045 (Influenza and Respiratory Syncytial Virus [RSV]) or mRNA-1230 (Influenza, RSV, and Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2]) Vaccine in Adults 50 to 75 Years Old

NCT05585632 | Completed Phase 1 FDA Drug

• 2 other identifiers: mRNA-1230-P1012022-002138-15
• Study Type: interventional
• Target: 392
• Locations: 3 countries
• Sites: 30

Brief Summary

The primary goal of this study is to evaluate the safety and reactogenicity of multi-component vaccines mRNA-1045 (Influenza and RSV) and mRNA-1230 (influenza, RSV, and SARS-CoV-2) compared with mRNA-1010 (influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) vaccines in healthy older participants.

Conditions

SARS-CoV-2; Influenza; RSV

Keywords

mRNA-1230 Vaccine; mRNA-1045 Vaccine; SARS-CoV-2 Vaccine; Influenza Vaccine; RSV Vaccine; Coronavirus; Virus Diseases; Messenger RNA; COVID-19; COVID-19 Vaccine; Moderna

Outcome Measures

Primary Outcomes (6)

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

  Up to Day 8 (7 days post vaccination)

• Number of Participants with Unsolicited Adverse Events (AEs)

  Up to Day 29 (28 days post vaccination)

• Number of Participants with Medically-Attended AEs (MAAEs)

  Day 1 through Day 361

• Number of Participants with Adverse Events of Special Interest (AESIs)

  Day 1 through Day 361

• Number of Participants with Serious Adverse Events (SAEs)

  Day 1 through Day 361

• Number of Participants with AEs Leading to Discontinuation

  Day 1 through Day 361

Secondary Outcomes (9)

• Change From Baseline in Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29

  Baseline (Day 1), Day 29

• Change From Baseline in GMT as Measured by Pseudovirus Neutralization Assay (PsVNA) (or Binding Antibody Assay) at Day 29

  Baseline (Day 1), Day 29

• Change From Baseline in GMT as Measured by Microneutralization Assay at Day 29

  Baseline (Day 1), Day 29

• Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29

  Baseline (Day 1), Day 29

• Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) at Day 29

  Baseline (Day 1), Day 29

Study Arms (9)

mRNA-1010

EXPERIMENTAL

Participants will receive a dose of mRNA-1010 by intramuscular (IM) injection on Day 1.

Biological: mRNA-1010

mRNA-1345

EXPERIMENTAL

Participants will receive a dose of mRNA-1345 by IM injection on Day 1.

Biological: mRNA-1345

mRNA-1273.214

EXPERIMENTAL

Participants will receive a dose of mRNA-1273.214 by IM injection on Day 1.

Biological: mRNA-1273.214

mRNA-1045 Dose Level A

EXPERIMENTAL

Participants will receive mRNA-1045 at Dose Level A by IM injection on Day 1.

Biological: mRNA-1045

mRNA-1045 Dose Level B

EXPERIMENTAL

Participants will receive mRNA-1045 at Dose Level B by IM injection on Day 1.

Biological: mRNA-1045

mRNA-1045 Dose Level C

EXPERIMENTAL

Participants will receive mRNA-1045 at Dose Level C by IM injection on Day 1.

Biological: mRNA-1045

mRNA-1230 Dose Level A

EXPERIMENTAL

Participants will receive mRNA-1230 at Dose Level A by IM injection on Day 1.

Biological: mRNA-1230

mRNA-1230 Dose Level B

EXPERIMENTAL

Participants will receive mRNA-1230 at Dose Level B by IM injection on Day 1.

Biological: mRNA-1230

mRNA-1230 Dose Level C

EXPERIMENTAL

Participants will receive mRNA-1230 at Dose Level C by IM injection on Day 1.

Biological: mRNA-1230

Interventions

mRNA-1010 BIOLOGICAL

Sterile liquid for injection

mRNA-1010

mRNA-1345 BIOLOGICAL

Sterile liquid for injection

mRNA-1345

mRNA-1273.214 BIOLOGICAL

Sterile liquid for injection

mRNA-1273.214

mRNA-1045 BIOLOGICAL

Formulation for injection

mRNA-1045 Dose Level A; mRNA-1045 Dose Level B; mRNA-1045 Dose Level C

mRNA-1230 BIOLOGICAL

Formulation for injection

mRNA-1230 Dose Level A; mRNA-1230 Dose Level B; mRNA-1230 Dose Level C

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Investigator assessment that participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
• Body mass index of 18 to 35 kilograms/square meter (kg/m\^2) (inclusive) at the Screening Visit(s).
• For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception or abstinence through 3 months following the vaccination, and not currently breastfeeding.
• Fully vaccinated for COVID-19 with an approved primary series according to the locally authorized or approved regimen. The most recent COVID-19 vaccine (primary series or booster) must be ≥120 days before (or less per local guidance) Day 1.

You may not qualify if:

• Acutely ill or febrile (temperature ≥38.0°Celsius/\[100.4°Fahrenheit\]) 72 hours before or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window for re-evaluation and will retain their initially assigned participant number.
• Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
• Has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months before screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
• Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days before study injections (Day 1) or within 28 days after the study injection.
• Received a licensed seasonal influenza vaccine or any other investigational influenza or RSV vaccine within ≤180 days before Day 1.
• Tested positive for influenza or RSV by local health authority-approved testing methods within ≤180 days before Day 1.
• Significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 14 days, as defined by the United States Center for Disease Control (CDC) or the European Centre for Disease Prevention and Control as a high risk (close contact) of a COVID-19 case or known history of SARS-CoV-2 infection within the past 90 days before Day 1.
• Donated ≥450 mL of blood products within 28 days before the Screening Visit or plans to donate blood products during the study.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (30)

Accel Research Sites

DeLand, Florida, 32720, United States

Location

Research Centers of America (cenexel)

Hollywood, Florida, 33024, United States

Location

Accel Research Sites

St. Petersburg, Florida, 33709, United States

Location

Atlanta Center for Medical Research - Family Medicine

Atlanta, Georgia, 30331, United States

Location

Centricity Research

Columbus, Georgia, 31904, United States

Location

Cenexel IRA (iResearch Atlanta)

Decatur, Georgia, 30030, United States

Location

Optimal Research

Peoria, Illinois, 61614, United States

Location

DM Clinical Research

Southfield, Michigan, 48076, United States

Location

Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC)

Morehead City, North Carolina, 28557, United States

Location

Trial Management Associates

Wilmington, North Carolina, 28403, United States

Location

Velocity Clinical Research

Anderson, South Carolina, 29621, United States

Location

Trial Management Associates

Myrtle Beach, South Carolina, 29572, United States

Location

DM Clinical Research

Houston, Texas, 77081, United States

Location

DM Clinical Research

Sugar Land, Texas, 77478, United States

Location

Paratus Clinical Research Western Sydney

Blacktown, New South Wales, 2148, Australia

Location

Paratus Clinical Kanwal

Kanwal, New South Wales, 2259, Australia

Location

Paratus Clinical Research Brisbane

Albion, Queensland, 4010, Australia

Location

Nucleus Network Brisbane Clinic - Centre For Clinical Studies

Herston, Queensland, 4006, Australia

Location

University of the Sunshine Coast

South Brisbane, Queensland, 4101, Australia

Location

AusTrials Taringa

Taringa, Queensland, QLD 4068, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

Newcastle University - Institute of Cellular Medicine (ICM)

Newcastle, England, NE2 4HH, United Kingdom

Location

Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC) Campus

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

University of Oxford

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Bristol Royal Hospital for Children

Bristol, BS2 8BJ, United Kingdom

Location

Royal Devon & Exeter Hospital

Exeter, EX25DW, United Kingdom

Location

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

St George's Healthcare NHS Trust - University of London - Th

London, SW17 0RE, United Kingdom

Location

National Hospital for Neurology and Neurosurgery

London, WC1N 3GB, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human; Coronavirus Infections; Virus Diseases; COVID-19

Interventions

mRNA-1010 influenza vaccine; mRNA-1345 respiratory syncytial virus vaccine; mRNA-1273.214 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases; Coronaviridae Infections; Nidovirales Infections; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants will be unblinded at Day 29 (1 month following study injection) to seek immunization with licensed influenza and/or SARS-CoV-2 vaccines, outside of the study, per local standard of care.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 19, 2022
• Study Start: October 14, 2022
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

GB (9); US (14); AU (7)