Phase
Condition
Influenza
Covid-19
Treatment
SARS-CoV-2 Vaccine
Licensed Influenza Vaccine
mRNA-1083
Clinical Study ID
Ages > 50 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Medically stable adults ≥50 years of age at the time of consent (Screening/Day 1Visit).
A participant who could become pregnant is eligible to participate if the followingis met:
Not pregnant or breast/chestfeeding, and is using a contraceptive method thatis highly effective for at least 90 days after the study interventionadministration and agrees not to donate eggs (ova, oocytes) for the purpose ofreproduction during this period.
Have a negative highly sensitive pregnancy test (urine) as required by localregulations at Screening/Day 1 Visit, before the study intervention.
Participants who can produce sperm are eligible to participate if they agree to thefollowing for at least 90 days after the study intervention administration:
Refrain from donating sperm.
Either be abstinent from reproductive sexual intercourse as their preferred andusual lifestyle (abstinent on a long term and persistent basis) and agree toremain abstinent or must agree to use an external condom with a person whocould become pregnant partner use of an additional highly effectivecontraceptive method with a failure rate of <1% per year when having sexualintercourse.
Agree to use an external condom when engaging in any activity that allows forpassage of ejaculate to another person.
Received ≥2 COVID-19 vaccines and the last COVID-19 vaccine was ≥150 days prior toDay 1
Exclusion
Key Exclusion Criteria:
History of a diagnosis or condition that, in the judgment of the Investigator, isclinically 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 ofdrug or alcohol abuse, that, in the opinion of the Investigator, might poseadditional risk due to participation in the study or could interfere with theinterpretation 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 intotal within 90 days prior to Day 1 or is anticipating the need for corticosteroidsat any time during the study. Inhaled nasal and topical steroids are allowed.
Received systemic immunosuppressive treatment, including long-acting biologicaltherapies that affect immune responses (for example, infliximab), within 180 daysprior to Day 1 or plans to do so during the study.
Received or plans to receive any vaccine authorized or approved by a local healthagency ≤28 days prior to study injections or plans to receive a vaccine authorizedor 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 daysprior to Day 1.
Has had close contact with someone with laboratory-confirmed influenza infection orwith someone who has been treated with antiviral therapies for influenza (forexample, Tamiflu) within 5 days prior to Day 1
Has had close contact to someone with COVID-19 as defined by the Centers for DiseaseControl 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 theScreening Visit/Day 1 or plans to donate blood products during the study.
Reported history of anaphylaxis or severe hypersensitivity reaction after receipt ofany 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.
Study Design
Connect with a study center
Daido Clinic
Nagoya-shi, Aichi 457-8511
JapanSite Not Available
Public Health Association.Inc.
Nagoya-shi, Aichi 453-0804
JapanSite Not Available
Daido Clinic
Nagoya 1856057, Aichi-ken 1865694 457-8511
JapanSite Not Available
Public Health Association.Inc.
Nagoya 1856057, Aichi-ken 1865694 453-0804
JapanSite Not Available
Fukuoka Heartnet Hospital
Fukuoka-shi, Fukuoka 819-0002
JapanSite Not Available
PS Clinic - Internal medicine
Fukuoka-shi, Fukuoka 812-0025
JapanSite Not Available
Tenjin Sogo Clinic
Fukuoka-shi, Fukuoka 810-0021
JapanSite Not Available
Fukuoka Heartnet Hospital
Fukuoka 1863967, Fukuoka 1863958 819-0002
JapanSite Not Available
PS Clinic - Internal medicine
Fukuoka 1863967, Fukuoka 1863958 812-0025
JapanSite Not Available
Tenjin Sogo Clinic
Fukuoka 1863967, Fukuoka 1863958 810-0021
JapanSite Not Available
Medical Coporation of Yamazaki Neurotology, Rhinolaryngology Clinical
Sapporo-shi, Hokkaido 060-0011
JapanSite Not Available
Medical Coporation of Yamazaki Neurotology, Rhinolaryngology Clinical
Sapporo 2128295, Hokkaido 2130037 060-0011
JapanSite Not Available
Motomachi Takatsuka Naika Clinic - Internal Medicine
Yokohama-shi, Kanagawa 231-0023
JapanSite Not Available
Motomachi Takatsuka Naika Clinic - Internal Medicine
Yokohama 1848354, Kanagawa 1860291 231-0023
JapanSite Not Available
Nishi-Kumamoto Hospital
Kumamoto-shi, Kumamoto 861-4157
JapanSite Not Available
Sakurajyuji Medical Corporation Medimesse Sakurajyuji Clinic
Kumamoto-shi, Kumamoto 860-0833
JapanSite Not Available
Nishi-Kumamoto Hospital
Kumamoto 1858421, Kumamoto 1858419 861-4157
JapanSite Not Available
Sakurajyuji Medical Corporation Medimesse Sakurajyuji Clinic
Kumamoto 1858421, Kumamoto 1858419 860-0833
JapanSite Not Available
Sato Hospital
Osaki-shi, Miyagi 2111888 989-6143
JapanSite Not Available
Yokoi Medicine Clinic
Mino, Osaka 1853904 562-0003
JapanSite Not Available
Shimamura Memorial Hospital
Nerima, Tokyo 177-0051
JapanSite Not Available
Denenchofu Family Clinic
Ota-ku, Tokyo 145-0071
JapanSite Not Available
Clinical Research Tokyo Hospital - Clinical Research Center
Shinjuku, Tokyo 160-0004
JapanSite Not Available
Higashi-Shinjuku Clinic - Internal Medicine
Shinjuku, Tokyo 169-0072
JapanSite Not Available
Shinwakai Adachi Kyosai Hospital - Internal Medicine
Adachi-ku, Tokyo 1850144 120-0022
JapanSite Not Available
Dojinkinenkai Meiwa Hospital
Chiyoda-ku, Tokyo 1850144 101-0041
JapanSite Not Available
Medical Corporation Asbo Tokyo Asbo Clinic
Chuo-ku, Tokyo 1850144 104-0031
JapanSite Not Available
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo 1850144 103-0025
JapanSite Not Available
Tokyo center clinic - Internal medicine
Chuo-ku, Tokyo 1850144 103-0027
JapanSite Not Available
New Medical Research System Clinic
Hachioji-shi, Tokyo 1850144 192-0046
JapanSite Not Available
Shimamura Memorial Hospital
Nerima City 11790394, Tokyo 1850144 177-0051
JapanSite Not Available
Hillside Clinic Jingumae
Shibuya-ku, Tokyo 1850144 150-0001
JapanSite Not Available
Clinical Research Tokyo Hospital - Clinical Research Center
Shinjuku 11790353, Tokyo 1850144 160-0004
JapanSite Not Available
Higashi-Shinjuku Clinic - Internal Medicine
Shinjuku 11790353, Tokyo 1850144 169-0072
JapanSite Not Available
Shinei Medical Healthcare Clinic
Suginami, Tokyo 1850144 166-0003
JapanSite Not Available
Souseikai Sumida Hospital
Sumida-Ku, Tokyo 1850144 130-0004
JapanSite Not Available
Seishukai Clinic
Taito-ku, Tokyo 1850144 111-0036
JapanSite Not Available
Metropolitan Clinic - Internal Medicine
Toshima-ku, Tokyo 1850144 171-0021
JapanSite Not Available
Denenchofu Family Clinic
Ōta-ku 8469289, Tokyo 1850144 145-0071
JapanSite Not Available
Korea University Ansan Hospital
Ansan-si, 15355
Korea, Republic ofSite Not Available
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, 14584
Korea, Republic ofSite Not Available
Dong-A University Hospital
Busan, 49201
Korea, Republic ofSite Not Available
Kyungpook National University Hospital - Infectious Diseases
Daegu,
Korea, Republic ofSite Not Available
Chonnam National University Hospital - Allergology
Gwangju, 61469
Korea, Republic ofSite Not Available
Inha University Hospital
Incheon, 22332
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, 13620
Korea, Republic ofSite Not Available
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
Korea, Republic ofSite Not Available
Korea University Guro Hospital
Seoul, 08308
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
Ajou University Hospital
Suwon, 16499
Korea, Republic ofSite Not Available
Yonsei University, Wonju Severance Christian Hospital
Wonju,
Korea, Republic ofSite Not Available
Korea University Ansan Hospital
Ansan-si 1846918, 15355
South KoreaSite Not Available
Kyungpook National University Hospital - Infectious Diseases
Daegu 1835329,
South KoreaSite Not Available
Chonnam National University Hospital - Allergology
Gwangju 1841811, 61469
South KoreaSite Not Available
Inha University Hospital
Incheon 1843564, 22332
South KoreaSite Not Available
Seoul National University Bundang Hospital
Seongnam-si 1897000, 13620
South KoreaSite Not Available
Hallym University Kangnam Sacred Heart Hospital
Seoul 1835848, 07441
South KoreaSite Not Available
Korea University Guro Hospital
Seoul 1835848, 08308
South KoreaSite Not Available
Severance Hospital, Yonsei University Health System
Seoul 1835848, 03722
South KoreaSite Not Available
Ajou University Hospital
Suwon 1835553, 16499
South KoreaSite Not Available
Yonsei University, Wonju Severance Christian Hospital
Wŏnju 1833105,
South KoreaSite Not Available
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung, 807
TaiwanSite Not Available
Kaohsiung Veterans General Hospital
Kaohsiung, 813 404
TaiwanSite Not Available
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City 1673820, 807
TaiwanSite Not Available
Kaohsiung Veterans General Hospital
Kaohsiung City 1673820, 813 404
TaiwanSite Not Available
Kuang Tien General Hospital - Dajia
Taichung, 437
TaiwanSite Not Available
Kuang Tien General Hospital - Dajia
Taichung 1668399, 437
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan, 704
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan 1668355, 704
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan City 1668355, 704
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 100
TaiwanSite Not Available
Taipei Medical University - Taipei Medical University Hospital
Taipei, 110
TaiwanSite Not Available
Tri-Service General Hospital - Neihu Branch - Infectious Diseases
Taipei, 114
TaiwanSite Not Available
National Taiwan University Hospital
Taipei 1668341, 100
TaiwanSite Not Available
Taipei Medical University - Taipei Medical University Hospital
Taipei 1668341, 110
TaiwanSite Not Available
Tri-Service General Hospital - Neihu Branch - Infectious Diseases
Taipei 1668341, 114
TaiwanSite Not Available
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
Taoyuan, 333
TaiwanSite Not Available
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
Taoyuan District 1667905, 333
TaiwanSite Not Available

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