Official Title
A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adults ≥50 Years of Age
Brief Summary

The purpose of the study is to evaluate the immunogenicity, reactogenicity, and safety ofmRNA-1083 in adults 50 years of age and older in participating countries (Japan, Taiwan,and South Korea).

Detailed Description

Not Provided

Active, not recruiting
COVID-19
Influenza

Biological: mRNA-1083

Suspension for injection

Other: Placebo

0.9% sodium chloride suspension for injection

Biological: Licensed Influenza Vaccine

Aqueous injectable (SC) or suspension for injection (IM)
Other Name: Influenza HA, Biken, and,Fluarix tetra

Biological: SARS-CoV-2 Vaccine

Suspension for injection
Other Name: mRNA-1273

Eligibility Criteria

Key Inclusion 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% 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 Exclusion 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.

Eligibility Gender
All
Eligibility Age
Minimum: 50 Years ~ Maximum: N/A
Countries
Japan
South Korea
Taiwan
Locations

Public Health Association.Inc.
Nagoya 1856057, Aichi-ken 1865694, Japan

Daido Clinic
Nagoya 1856057, Aichi-ken 1865694, Japan

Tenjin Sogo Clinic
Fukuoka 1863967, Fukuoka 1863958, Japan

PS Clinic - Internal medicine
Fukuoka 1863967, Fukuoka 1863958, Japan

Fukuoka Heartnet Hospital
Fukuoka 1863967, Fukuoka 1863958, Japan

Medical Coporation of Yamazaki Neurotology, Rhinolaryngology Clinical
Sapporo 2128295, Hokkaido 2130037, Japan

Motomachi Takatsuka Naika Clinic - Internal Medicine
Yokohama 1848354, Kanagawa 1860291, Japan

Sakurajyuji Medical Corporation Medimesse Sakurajyuji Clinic
Kumamoto 1858421, Kumamoto 1858419, Japan

Nishi-Kumamoto Hospital
Kumamoto 1858421, Kumamoto 1858419, Japan

Sato Hospital
Osaki-shi, Miyagi 2111888, Japan

Yokoi Medicine Clinic
Mino, Osaka 1853904, Japan

Shinwakai Adachi Kyosai Hospital - Internal Medicine
Adachi-ku, Tokyo 1850144, Japan

Dojinkinenkai Meiwa Hospital
Chiyoda-ku, Tokyo 1850144, Japan

Nihonbashi Sakura Clinic
Chuo-ku, Tokyo 1850144, Japan

Tokyo center clinic - Internal medicine
Chuo-ku, Tokyo 1850144, Japan

Medical Corporation Asbo Tokyo Asbo Clinic
Chuo-ku, Tokyo 1850144, Japan

New Medical Research System Clinic
Hachioji-shi, Tokyo 1850144, Japan

Shimamura Memorial Hospital
Nerima City 11790394, Tokyo 1850144, Japan

Denenchofu Family Clinic
Ōta-ku 8469289, Tokyo 1850144, Japan

Hillside Clinic Jingumae
Shibuya-ku, Tokyo 1850144, Japan

Clinical Research Tokyo Hospital - Clinical Research Center
Shinjuku 11790353, Tokyo 1850144, Japan

Higashi-Shinjuku Clinic - Internal Medicine
Shinjuku 11790353, Tokyo 1850144, Japan

Shinei Medical Healthcare Clinic
Suginami, Tokyo 1850144, Japan

Souseikai Sumida Hospital
Sumida-Ku, Tokyo 1850144, Japan

Seishukai Clinic
Taito-ku, Tokyo 1850144, Japan

Metropolitan Clinic - Internal Medicine
Toshima-ku, Tokyo 1850144, Japan

Korea University Ansan Hospital
Ansan-si 1846918, South Korea

Kyungpook National University Hospital - Infectious Diseases
Daegu 1835329, South Korea

Chonnam National University Hospital - Allergology
Gwangju 1841811, South Korea

Inha University Hospital
Incheon 1843564, South Korea

Seoul National University Bundang Hospital
Seongnam-si 1897000, South Korea

Severance Hospital, Yonsei University Health System
Seoul 1835848, South Korea

Hallym University Kangnam Sacred Heart Hospital
Seoul 1835848, South Korea

Korea University Guro Hospital
Seoul 1835848, South Korea

Ajou University Hospital
Suwon 1835553, South Korea

Yonsei University, Wonju Severance Christian Hospital
Wŏnju 1833105, South Korea

Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City 1673820, Taiwan

Kaohsiung Veterans General Hospital
Kaohsiung City 1673820, Taiwan

Kuang Tien General Hospital - Dajia
Taichung 1668399, Taiwan

National Cheng Kung University Hospital
Tainan City 1668355, Taiwan

National Taiwan University Hospital
Taipei 1668341, Taiwan

Taipei Medical University - Taipei Medical University Hospital
Taipei 1668341, Taiwan

Tri-Service General Hospital - Neihu Branch - Infectious Diseases
Taipei 1668341, Taiwan

Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
Taoyuan District 1667905, Taiwan

Not Provided

ModernaTX, Inc.
NCT Number
Keywords
Influenza
Covid-19
Messenger RNA
Moderna
MeSH Terms
COVID-19
Influenza, Human
COVID-19 Vaccines
2019-nCoV Vaccine mRNA-1273