Status:
COMPLETED
A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
Lead Sponsor:
ModernaTX, Inc.
Conditions:
SARS-CoV-2
Influenza
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 sy...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2024
Estimated Enrollment :
8061 Patients enrolled
Trial Details
Trial ID
NCT06097273
Start Date
October 19 2023
End Date
May 28 2024
Last Update
July 1 2025
Active Locations (146)
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1
Pinnacle Research Group-409 E 10th St
Anniston, Alabama, United States, 36207-4780
2
Accel Research Site - Achieve - Birmingham
Birmingham, Alabama, United States, 35216
3
Cullman Clinical Trials
Cullman, Alabama, United States, 35055-1902
4
Desert Clinical Research - CCT - PPDS
Mesa, Arizona, United States, 85213-5226