Phase
Condition
Influenza
Covid-19
Treatment
SARS-CoV-2 Vaccine
Placebo
Licensed Influenza Vaccine
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
JapanActive - Recruiting
Public Health Association.Inc.
Nagoya-shi, Aichi 453-0804
JapanActive - Recruiting
Fukuoka Heartnet Hospital
Fukuoka-shi, Fukuoka 819-0002
JapanActive - Recruiting
PS Clinic - Internal medicine
Fukuoka-shi, Fukuoka 812-0025
JapanActive - Recruiting
Tenjin Sogo Clinic
Fukuoka-shi, Fukuoka 810-0021
JapanActive - Recruiting
Medical Coporation of Yamazaki Neurotology, Rhinolaryngology Clinical
Sapporo-shi, Hokkaido 060-0011
JapanActive - Recruiting
Motomachi Takatsuka Naika Clinic - Internal Medicine
Yokohama-shi, Kanagawa 231-0023
JapanActive - Recruiting
Nishi-Kumamoto Hospital
Kumamoto-shi, Kumamoto 861-4157
JapanActive - Recruiting
Sakurajyuji Medical Corporation Medimesse Sakurajyuji Clinic
Kumamoto-shi, Kumamoto 860-0833
JapanActive - Recruiting
Sato Hospital
Osaki-shi, Miyagi 989-6143
JapanActive - Recruiting
Yokoi Medicine Clinic
Mino, Osaka 562-0003
JapanActive - Recruiting
Shinwakai Adachi Kyosai Hospital - Internal Medicine
Adachi-ku, Tokyo 120-0022
JapanActive - Recruiting
Dojinkinenkai Meiwa Hospital
Chiyoda-ku, Tokyo 101-0041
JapanActive - Recruiting
Medical Corporation Asbo Tokyo Asbo Clinic
Chuo-ku, Tokyo 104-0031
JapanActive - Recruiting
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo 103-0025
JapanActive - Recruiting
Tokyo center clinic - Internal medicine
Chuo-ku, Tokyo 103-0027
JapanActive - Recruiting
New Medical Research System Clinic
Hachioji-shi, Tokyo 192-0046
JapanActive - Recruiting
Shimamura Memorial Hospital
Nerima, Tokyo 177-0051
JapanActive - Recruiting
Denenchofu Family Clinic
Ota-ku, Tokyo 145-0071
JapanActive - Recruiting
Hillside Clinic Jingumae
Shibuya-ku, Tokyo 150-0001
JapanActive - Recruiting
Clinical Research Tokyo Hospital - Clinical Research Center
Shinjuku, Tokyo 160-0004
JapanActive - Recruiting
Higashi-Shinjuku Clinic - Internal Medicine
Shinjuku, Tokyo 169-0072
JapanActive - Recruiting
Shinei Medical Healthcare Clinic
Suginami, Tokyo 166-0003
JapanActive - Recruiting
Souseikai Sumida Hospital
Sumida-Ku, Tokyo 130-0004
JapanActive - Recruiting
Seishukai Clinic
Taito-ku, Tokyo 111-0036
JapanActive - Recruiting
Metropolitan Clinic - Internal Medicine
Toshima-ku, Tokyo 171-0021
JapanActive - Recruiting
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
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung, 807
TaiwanSite Not Available
Kaohsiung Veterans General Hospital
Kaohsiung, 813 404
TaiwanSite Not Available
Kuang Tien General Hospital - Dajia
Taichung, 437
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan, 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
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
Taoyuan, 333
TaiwanSite Not Available
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