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

Moderna

Status and phase: Completed; Phase 3

Conditions: Influenza; SARS-CoV-2

Treatments: Biological: COVID-19 Vaccine; Biological: mRNA-1083; Biological: Influenza Vaccine; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06097273

mRNA-1083-P301

Details and patient eligibility

About

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).

Enrollment: 8,075 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8,075 participants in 4 patient groups

Cohort A1: mRNA-1083 and Placebo

Experimental group

Description:

Participants of age 65 years and older will receive mRNA-1083 and placebo administered as 2 intramuscular (IM) injections of on Day 1.

Treatment:

Biological: Placebo

Biological: mRNA-1083

Cohort A2: Influenza Vaccine and COVID-19 Vaccine

Active Comparator group

Description:

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.

Treatment:

Biological: Influenza Vaccine

Biological: COVID-19 Vaccine

Cohort B1: mRNA-1083 and Placebo

Experimental group

Description:

Participants of age 50 to \<65 years will receive mRNA-1083 and placebo administered as 2 IM injections of on Day 1.

Treatment:

Biological: Placebo

Biological: mRNA-1083

Cohort B2: Influenza Vaccine and COVID-19 Vaccine

Active Comparator group

Description:

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.

Treatment:

Biological: Influenza Vaccine

Biological: COVID-19 Vaccine