Purpose

The study is divided into 2 parts: Part 1 and Part 2. The purpose of Part 1 of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults. The purpose of Part 2 of this study is to generate safety and immunogenicity data for additional mRNA-1083 compositions and dose levels in young adults ≥18 years and <50 years of age.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 79 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

Part 1 (Phase 1/2) - Adults ≥18 to <80 years of age at the time of consent. - Body mass index (BMI) of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the Screening Visit. - Healthy as determined by medical evaluation, including medical history, physical examination, and laboratory tests. - 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 through 90 days following vaccine administration, and not currently breastfeeding. - 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 ≥120 days prior to Day 1. Part 2 (Phase 2 Extension) - Adults ≥18 to <50 years of age at the time of consent. - BMI of 18 kg/m^2 to 35 kg/m^2 (inclusive) at the Screening Visit. - Healthy as determined by medical evaluation, including medical history, and physical examination. - 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 through 90 days following vaccine administration, and not currently breastfeeding. - Have received at least 2 doses of locally authorized or approved COVID-19 vaccines and last dose was ≥90 days prior to Day 1.

Exclusion Criteria

Part 1 (Phase 1/2) and Part 2 (Phase 2 Extension) - 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 clinical trial or could interfere with the interpretation of study results. - Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Screening Visit (for glucocorticoids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed. - Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration. - Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to Day 1. - Participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1. - Participant 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. - 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 clinical trial. - Working or has worked as study personnel, is an immediate family member or household member of study personnel, study site staff, or Sponsor personnel, or resides in a nursing home. Part 2 (Phase 2 Extension) Only - Participants who enrolled in Part 1 of the mRNA-1083-P101 (Phase 1/2) study. Note: Other inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1 Cohort A2: mRNA-1083.1 Dose B
Participants will receive single intramuscular (IM) injection of mRNA-1083.1 at Dose Level B on Day 1.
  • Biological: mRNA-1083.1
    Sterile liquid for injection
Experimental
Part 1 Cohort A3: mRNA-1083.1 Dose C
Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.
  • Biological: mRNA-1083.1
    Sterile liquid for injection
Experimental
Part 1 Cohort A4: mRNA-1083.2 Dose A
Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.
  • Biological: mRNA-1083.2
    Sterile liquid for injection
Experimental
Part 1 Cohort A5: mRNA-1083.2 Dose B
Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.
  • Biological: mRNA-1083.2
    Sterile liquid for injection
Experimental
Part 1 Cohort A6: mRNA-1083.2 Dose C
Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.
  • Biological: mRNA-1083.2
    Sterile liquid for injection
Experimental
Part 1 Cohort A7: mRNA-1083.3
Participants will receive single IM injection of mRNA-1083.3 on Day 1.
  • Biological: mRNA-1083.3
    Sterile liquid for injection
Active Comparator
Part 1 Cohort A8: Investigational Influenza Vaccine 1
Participants will receive single IM injection of Investigational Influenza Vaccine 1 on Day 1.
  • Biological: Investigational Influenza Vaccine 1
    Sterile liquid for injection
Active Comparator
Part 1 Cohort A9: Investigational COVID-19 Vaccine 1
Participants will receive single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
  • Biological: Investigational COVID-19 Vaccine 1
    Sterile liquid for injection
Active Comparator
Part 1 Cohort A10: COVID-19 Vaccine 1
Participants will receive single IM injection of COVID-19 Vaccine 1 on Day 1.
  • Biological: COVID-19 Vaccine 1
    Sterile liquid for injection
Active Comparator
Part 1 Cohort A11: Investigational Influenza Vaccine 2
Participants will receive single IM injection of Investigational Influenza Vaccine 2 on Day 1.
  • Biological: Investigational Influenza Vaccine 2
    Sterile liquid for injection
Active Comparator
Part 1 Cohort A12: Influenza Vaccine 1
Participants will receive single IM injection of Influenza Vaccine 1 on Day 1.
  • Biological: Influenza Vaccine 1
    quadrivalent seasonal influenza vaccine
Active Comparator
Part 1 Cohort A13: Influenza Vaccine 2
Participants will receive single IM injection of Influenza Vaccine 2 on Day 1.
  • Biological: Influenza Vaccine 2
    quadrivalent seasonal influenza vaccine
Experimental
Part 1 Cohort B1: mRNA-1083.1 Dose A
Participants will receive single IM injection of mRNA-1083.1 at Dose Level A on Day 1.
  • Biological: mRNA-1083.1
    Sterile liquid for injection
Experimental
Part 1 Cohort B2: mRNA-1083.1 Dose B
Participants will receive single IM injection of mRNA-1083.1 at Dose Level B on Day 1.
  • Biological: mRNA-1083.1
    Sterile liquid for injection
Experimental
Part 1 Cohort B3: mRNA-1083.1 Dose C
Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.
  • Biological: mRNA-1083.1
    Sterile liquid for injection
Experimental
Part 1 Cohort B4: mRNA-1083.2 Dose A
Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.
  • Biological: mRNA-1083.2
    Sterile liquid for injection
Experimental
Part 1 Cohort B5: mRNA-1083.2 Dose B
Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.
  • Biological: mRNA-1083.2
    Sterile liquid for injection
Experimental
Part 1 Cohort B6: mRNA-1083.2 Dose C
Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.
  • Biological: mRNA-1083.2
    Sterile liquid for injection
Experimental
Part 1 Cohort B7: mRNA-1083.3
Participants will receive single IM injection of mRNA-1083.3 on Day 1.
  • Biological: mRNA-1083.3
    Sterile liquid for injection
Active Comparator
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants will receive single IM injection of Investigational Influenza Vaccine 1 on Day 1.
  • Biological: Investigational Influenza Vaccine 1
    Sterile liquid for injection
Active Comparator
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants will receive single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
  • Biological: Investigational COVID-19 Vaccine 1
    Sterile liquid for injection
Active Comparator
Part 1 Cohort B10: COVID-19 Vaccine 1
Participants will receive single IM injection of COVID-19 Vaccine 1 on Day 1.
  • Biological: COVID-19 Vaccine 1
    Sterile liquid for injection
Active Comparator
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants will receive single IM injection of Investigational Influenza Vaccine 2 on Day 1.
  • Biological: Investigational Influenza Vaccine 2
    Sterile liquid for injection
Active Comparator
Part 1 Cohort B12: Influenza Vaccine 1
Participants will receive single IM injection of Influenza Vaccine 1 on Day 1.
  • Biological: Influenza Vaccine 1
    quadrivalent seasonal influenza vaccine
Experimental
Part 2: mRNA-1083 Composition 1 Dose A
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level A on Day 1.
  • Biological: mRNA-1083
    Sterile liquid for injection
Experimental
Part 2: mRNA-1083 Composition 2 Dose A
Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level A on Day 1.
  • Biological: mRNA-1083
    Sterile liquid for injection
Experimental
Part 2: mRNA-1083 Composition 1 Dose B
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level B on Day 1.
  • Biological: mRNA-1083
    Sterile liquid for injection
Experimental
Part 2: mRNA-1083 Composition 2 Dose B
Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level B on Day 1.
  • Biological: mRNA-1083
    Sterile liquid for injection
Experimental
Part 2: mRNA-1083 Composition 1 Dose C
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level C on Day 1.
  • Biological: mRNA-1083
    Sterile liquid for injection
Experimental
Part 2: mRNA-1083 Composition 2 Dose C
Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level C on Day 1.
  • Biological: mRNA-1083
    Sterile liquid for injection
Experimental
Part 2: mRNA-1083 Composition 1 Dose D
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level D on Day 1.
  • Biological: mRNA-1083
    Sterile liquid for injection
Experimental
Part 2: mRNA-1083 Composition 2 Dose D
Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level D on Day 1.
  • Biological: mRNA-1083
    Sterile liquid for injection
Active Comparator
Part 2: Investigational Influenza Vaccine 1 Dose A
Participants will receive single IM injection of Investigational Influenza Vaccine 1 at Dose Level A on Day 1.
  • Biological: Investigational Influenza Vaccine 1
    Sterile liquid for injection
Active Comparator
Part 2: Investigational Influenza Vaccine 1 Dose B
Participants will receive single IM injection of Investigational Influenza Vaccine 1 at Dose Level B on Day 1.
  • Biological: Investigational Influenza Vaccine 1
    Sterile liquid for injection
Active Comparator
Part 2: Investigational COVID-19 Vaccine 2
Participants will receive single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
  • Biological: Investigational COVID-19 Vaccine 2
    Sterile liquid for injection
Active Comparator
Part 2: COVID-19 Vaccine 2
Participants will receive single IM injection of COVID-19 Vaccine 2 on Day 1.
  • Biological: COVID-19 Vaccine 2
    Sterile liquid for injection
Active Comparator
Part 2: Influenza Vaccine 1
Participants will receive single IM injection of Influenza Vaccine 1 on Day 1.
  • Biological: Influenza Vaccine 1
    quadrivalent seasonal influenza vaccine

Recruiting Locations

More Details

NCT ID
NCT05827926
Status
Active, not recruiting
Sponsor
ModernaTX, Inc.

Detailed Description

Part 1: Participants will be enrolled into 1 of 2 age cohorts: Cohort A for adults ≥65 to <80 years of age or Cohort B for adults ≥18 to <65 year of age. In Cohort A, approximately 600 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since September 2022). In Cohort B, approximately 624 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by 2 age groups: ≥18 to <50 years and ≥50 to <65 years of age and by influenza vaccine status in the most recent influenza season (received or not received since September 2022). Part 2: Approximately, 520 participants between ≥18 to <50 years of age will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since Sept 2023).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.