A Study of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

• ClinicalTrials.gov Identifier: NCT06097273
• Recruitment Status: Active, not recruiting
• First Posted: October 24, 2023
• Last Update Posted: December 20, 2023
• Sponsor: ModernaTX, Inc.
• Information provided by (Responsible Party): ModernaTX, Inc.

Tracking Information

• First Submitted Date: October 18, 2023
• First Posted Date: October 24, 2023
• Last Update Posted Date: December 20, 2023
• Actual Study Start Date: October 19, 2023
• Estimated Primary Completion Date: May 21, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 18, 2023)

• Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay [ Time Frame: Day 29 ]
• GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA) [ Time Frame: Day 29 ]
• Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay [ Time Frame: Baseline to Day 29 ]
  Seroconversion is defined as a Day 29 post-injection level ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.
• SARS-CoV-2: Number of Participants with Seroresponse, as Measured by PsVNA [ Time Frame: Baseline to Day 29 ]
  Seroresponse is defined as a Day 29 post-injection level ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4*LLOQ if baseline titer is <LLOQ in neutralizing antibody (nAb) values measured by PsVNA.
• Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to 7 days after study injection ]
• Number of Participants With Unsolicited Adverse Events (AEs) [ Time Frame: Up to 28 days after study injection ]
• Number of Participants With Medically Attended Adverse Events (MAAEs) [ Time Frame: Day 1 through Day 181 ]
• Number of Participants With Adverse Events of Special Interest (AESIs) [ Time Frame: Day 1 through Day 181 ]
• Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Day 1 through Day 181 ]
• Number of Participants With AEs Leading to Discontinuation [ Time Frame: Day 1 through Day 181 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 18, 2023)

• Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay [ Time Frame: Day 1, Day 29 ]
• GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA [ Time Frame: Day 1, Day 29 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
• Official Title: A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
• Brief Summary: The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to <65 years of age (Cohort B).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• SARS-CoV-2
• Influenza

Intervention

• Biological: mRNA-1083
  Suspension for injection
• Biological: Placebo
  0.9% sodium chloride suspension for injection
• Biological: Influenza Vaccine
  Commercially available formulation (Suspension for injection [pre-filled syringe])
• Biological: COVID-19 Vaccine
  Commercially available formulation (Suspension for injection)

Study Arms

• Experimental: Cohort A1: mRNA-1083 and Placebo
  Participants of age 65 years and older will receive mRNA-1083 and placebo administered as 2 intramuscular (IM) injections of on Day 1.
  Interventions:

  • Biological: mRNA-1083
  • Biological: Placebo
• Active Comparator: Cohort A2: Influenza Vaccine and COVID-19 Vaccine
  Participants of age 65 years and older will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1.
  Interventions:

  • Biological: Influenza Vaccine
  • Biological: COVID-19 Vaccine
• Experimental: Cohort B1: mRNA-1083 and Placebo
  Participants of age 50 to <65 years will receive mRNA-1083 and placebo administered as 2 IM injections of on Day 1.
  Interventions:

  • Biological: mRNA-1083
  • Biological: Placebo
• Active Comparator: Cohort B2: Influenza Vaccine and COVID-19 Vaccine
  Participants of age 50 to <65 years will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1.
  Interventions:

  • Biological: Influenza Vaccine
  • Biological: COVID-19 Vaccine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: December 18, 2023): 8075
• Original Estimated Enrollment (submitted: October 18, 2023): 8000
• Estimated Study Completion Date: May 21, 2024
• Estimated Primary Completion Date: May 21, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

• Healthy adults either ≥65 years of age (Cohort A) or 50 to <65 years of age (Cohort B) at the time of consent (Screening Visit).
• 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, and agreement to continue adequate contraception through 3 months following vaccine administration.
• Fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was ≥90 days prior to Day 1.

Exclusion Criteria:

• Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
• 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.
• Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled nasal and topical steroids are allowed.
• Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
• Received a seasonal influenza vaccine ≤150 days prior to Day 1.
• Tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
• Has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1.
• 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.

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States
• Removed Location Countries: Canada

Administrative Information

• NCT Number: NCT06097273
• Other Study ID Numbers: mRNA-1083-P301
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: ModernaTX, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: ModernaTX, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: ModernaTX, Inc.
• Verification Date: December 2023