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The purpose of the study is to evaluate the immunogenicity, reactogenicity, and safety of mRNA-1083 in adults 50 years of age and older in participating countries (Japan, Taiwan, and South Korea).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1083 and Placebo | Experimental | Participants 50 years of age and older will receive mRNA-1083 by intramuscular (IM) injection and placebo by subcutaneous (SC) or IM injection administered on Day 1. |
|
| Licensed influenza vaccine + SARS-CoV-2 vaccine | Active Comparator | Participants of age 50 years and older will receive licensed influenza vaccine by SC or IM injection and SARS-CoV-2 vaccine by IM injection administered on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1083 | Biological | Suspension for injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay | Day 29 | |
| GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA) | 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 through Day 181 | |
| Number of Participants With AEs Leading to Discontinuation | Day 1 through Day 181 |
| Measure | Description | Time Frame |
|---|---|---|
| Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay | Seroconversion is defined as a Day 29 post-injection level ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay. | Day 29 |
| SARS-CoV-2: Percentage of Participants with Seroresponse, as Measured by PsVNA |
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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:
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:
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:
Note: Other protocol-defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health Association.Inc. | Nagoya | Aichi-ken | 453-0804 | Japan | ||
| Daido Clinic |
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| Placebo |
| Other |
0.9% sodium chloride suspension for injection |
|
| Licensed Influenza Vaccine | Biological | Aqueous injectable (SC) or suspension for injection (IM) |
|
|
| SARS-CoV-2 Vaccine | Biological | Suspension for injection |
|
|
Seroresponse is defined as a Day 29 post-injection level ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4*LLOQ if baseline titer is \ |
| Day 29 |
| Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay | Day 1, Day 29 |
| GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | Day 1, Day 29 |
| Nagoya |
| Aichi-ken |
| 457-8511 |
| Japan |
| Tenjin Sogo Clinic | Fukuoka | Fukuoka | 810-0021 | Japan |
| PS Clinic - Internal medicine | Fukuoka | Fukuoka | 812-0025 | Japan |
| Fukuoka Heartnet Hospital | Fukuoka | Fukuoka | 819-0002 | Japan |
| Medical Coporation of Yamazaki Neurotology, Rhinolaryngology Clinical | Sapporo | Hokkaido | 060-0011 | Japan |
| Motomachi Takatsuka Naika Clinic - Internal Medicine | Yokohama | Kanagawa | 231-0023 | Japan |
| Sakurajyuji Medical Corporation Medimesse Sakurajyuji Clinic | Kumamoto | Kumamoto | 860-0833 | Japan |
| Nishi-Kumamoto Hospital | Kumamoto | Kumamoto | 861-4157 | Japan |
| Sato Hospital | Osaki-shi | Miyagi | 989-6143 | Japan |
| Yokoi Medicine Clinic | Mino | Osaka | 562-0003 | Japan |
| Shinwakai Adachi Kyosai Hospital - Internal Medicine | Adachi-ku | Tokyo | 120-0022 | Japan |
| Dojinkinenkai Meiwa Hospital | Chiyoda-ku | Tokyo | 101-0041 | Japan |
| Nihonbashi Sakura Clinic | Chuo-ku | Tokyo | 103-0025 | Japan |
| Tokyo center clinic - Internal medicine | Chuo-ku | Tokyo | 103-0027 | Japan |
| Medical Corporation Asbo Tokyo Asbo Clinic | Chuo-ku | Tokyo | 104-0031 | Japan |
| New Medical Research System Clinic | Hachioji-shi | Tokyo | 192-0046 | Japan |
| Shimamura Memorial Hospital | Nerima City | Tokyo | 177-0051 | Japan |
| Denenchofu Family Clinic | Ōta-ku | Tokyo | 145-0071 | Japan |
| Hillside Clinic Jingumae | Shibuya-ku | Tokyo | 150-0001 | Japan |
| Clinical Research Tokyo Hospital - Clinical Research Center | Shinjuku | Tokyo | 160-0004 | Japan |
| Higashi-Shinjuku Clinic - Internal Medicine | Shinjuku | Tokyo | 169-0072 | Japan |
| Shinei Medical Healthcare Clinic | Suginami | Tokyo | 166-0003 | Japan |
| Souseikai Sumida Hospital | Sumida-Ku | Tokyo | 130-0004 | Japan |
| Seishukai Clinic | Taito-ku | Tokyo | 111-0036 | Japan |
| Metropolitan Clinic - Internal Medicine | Toshima-ku | Tokyo | 171-0021 | Japan |
| Korea University Ansan Hospital | Ansan-si | 15355 | South Korea |
| Kyungpook National University Hospital - Infectious Diseases | Daegu | South Korea |
| Chonnam National University Hospital - Allergology | Gwangju | 61469 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Seoul | 07441 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Ajou University Hospital | Suwon | 16499 | South Korea |
| Yonsei University, Wonju Severance Christian Hospital | Wŏnju | South Korea |
| Kaohsiung Medical University - Chung-Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 813 404 | Taiwan |
| Kuang Tien General Hospital - Dajia | Taichung | 437 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Taipei Medical University - Taipei Medical University Hospital | Taipei | 110 | Taiwan |
| Tri-Service General Hospital - Neihu Branch - Infectious Diseases | Taipei | 114 | Taiwan |
| Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital | Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |
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