A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of a SARS-CoV-2 (COVID-19) and Influenza Vaccine (mRNA-1083) in Adults >=50 Years of Age.

JRCT ID: jRCT2031240429

Registered date:23/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Adults =>50 Years of Age
• Date of first enrollment: 18/11/2024
• Target sample size: 2000
• Countries of recruitment: Korea,Japan,Taiwan,Japan
• Study type: Interventional
• Intervention(s): Participants 50 years of age and older will receive mRNA-1083 by intramuscular (IM) injection and placebo by subcutaneous (SC) injection administered on Day 1.

Outcome(s)

Primary Outcome

-Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29
-GM Level of Antibodies for SARS CoV 2, as Measured by Pseudovirus Neutralization Assay (PsVNA) at Day 29
-Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Day 1 through 7 days after study injection
- Number of Participants With Unsolicited Adverse Events (AEs) Day 1 through 28 days after study injection
- Number of Participants With Medically Attended Adverse Events (MAAEs) Day 1 though Day 181
- Number of Participants With Adverse Events of Special Interest (AESIs) Day 1 though Day 181
- Number of Participants With Serious Adverse Events (SAEs) Day 1 though Day 181
- Number of Participants With AEs Leading to Discontinuation Day 1 though Day 181

Secondary Outcome

- Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay at Day 29
- SARS-CoV-2: Percentage of Participants with Seroresponse, as Measured by PsVNA at Day 29
- Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay at Day 1 and Day 29
- GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA at Day 1 and Day 29

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Medically stable adults =>50 years of age at the time of consent (Screening/Day 1 Visit).
A participant who could become pregnant is eligible to participate if the following is met:
-- Not pregnant or breast/chestfeeding, and is using a contraceptive method that is highly effective for at least 90 days after the study intervention administration and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.
-- Have a negative highly sensitive pregnancy test (urine) as required by local regulations at Screening/Day 1 Visit, before the study intervention.
Participants who can produce sperm are eligible to participate if they agree to the following for at least 90 days after the study intervention administration:
--Refrain from donating sperm.
-- Either be abstinent from reproductive sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or must agree to use an external condom with a person who could become pregnant partner use of an additional highly effective contraceptive method with a failure rate of <1 percent per year when having sexual intercourse.
-- Agree to use an external condom when engaging in any activity that allows for passage of ejaculate to another person.
Received =>2 COVID-19 vaccines and the last COVID-19 vaccine was =>150 days prior to Day 1 Key

Exclude criteria

- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
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.
- Known history of SARS CoV 2 infection within 150 days prior to Day 1.
- Tested positive for influenza by local health authority approved testing methods =<150 days prior to Day 1.
- Received corticosteroids at =>10 mg/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study. Inhaled nasal and topical steroids are allowed.
- Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (for example, infliximab), within 180 days prior to Day 1 or plans to do so during the study.
- 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.
- Treated with antiviral therapies for influenza (for example, Tamiflu) =<150 days prior to Day 1.
- Has had close contact with someone with laboratory confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu) within 5 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/Day 1 or plans to donate blood products during the study.
- Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein.
Note: Other protocol-defined inclusion/exclusion criteria may apply.

Related Information

• Primary Sponsor: Rumyantsev Alexander