計劃書編號mRNA-1083-P302
試驗已結束
2024-12-01 - 2025-11-30
Phase III
召募中8
ICD-10J17
歸類於他處疾病所致之肺炎
ICD-9484.8
其他感染疾病所致之肺炎
一項第三期、隨機分配、觀察者盲性、活性對照試驗，評估mRNA‑1083 (SARS‑CoV‑2和流感)疫苗用於50歲以上健康成人的免疫原性、反應原性與安全性
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試驗申請者
百瑞精鼎國際股份有限公司
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試驗委託 / 贊助單位名稱
百瑞精鼎國際股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/04/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
嚴重急性呼吸道症候群冠狀病毒2型、流感
試驗目的
試驗目的為評估參與國家（日本、台灣、韓國）≥ 50 YOA之成人的mRNA-1083免疫原性、反應原性與安全性。
藥品名稱
懸浮注射劑
主成份
mRNA-1083
劑型
275
劑量
NA
評估指標
• 第29天時，以血球凝集抑制試驗（HAI）測量的流感抗體幾何平均值（GM）濃度
• 第29天時，以假病毒中和試驗（PsVNA）測量的SARS-CoV-2抗體幾何平均值（GM）濃度
• 試驗注射後第1天至第7天期間，發生徵求之局部和全身性不良反應（AR）的參與者人數
• 試驗注射後第1天至第28天期間，發生非徵求之不良事件（AE）的參與者人數
• 第1天至第181天期間，發生需就醫之不良事件（MAAE）的參與者人數
• 第1天至第181天期間，發生特別關注不良事件（AESI）的參與者人數
• 第1天至第181天期間，發生嚴重不良事件（SAE）的參與者人數
• 第1天至第181天期間，因不良事件導致中止試驗的參與者人數
• 第29天時，以假病毒中和試驗（PsVNA）測量的SARS-CoV-2抗體幾何平均值（GM）濃度
• 試驗注射後第1天至第7天期間，發生徵求之局部和全身性不良反應（AR）的參與者人數
• 試驗注射後第1天至第28天期間，發生非徵求之不良事件（AE）的參與者人數
• 第1天至第181天期間，發生需就醫之不良事件（MAAE）的參與者人數
• 第1天至第181天期間，發生特別關注不良事件（AESI）的參與者人數
• 第1天至第181天期間，發生嚴重不良事件（SAE）的參與者人數
• 第1天至第181天期間，因不良事件導致中止試驗的參與者人數
主要納入條件
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.
- 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.
試驗計畫預計收納受試者人數
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台灣人數
150 人
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全球人數
2450 人
