計劃書編號V118_24
試驗執行中
2023-09-01 - 2026-06-30
Phase III
召募中5
ICD-10J09.X1
確認新型流感A型病毒所致流行性感冒併肺炎
ICD-10J10.00
其他確認流感病毒所致流行性感冒併未明示類型肺炎
ICD-10J10.08
其他確認流感病毒所致流行性感冒併其他特定肺炎
ICD-10J11.00
未確認流感病毒所致流行性感冒併未明示類型肺炎
ICD-10J11.08
未確認流感病毒所致流行性感冒併明示類型肺炎
ICD-9487.0
流行性感冒併肺炎
一項第3/3b 期、隨機分配、觀察者盲性、多中心臨床試驗，評估含MF59 佐劑的次單位非活化型流感疫苗相較於無佐劑流感疫苗對≥ 65 歲成人的療效、安全性及免疫原性
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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
2026/02/01
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
適應症
主要試驗指標及次要試驗指標提供於第8.1 節，試驗指標。The primary efficacy endpoints are defined as the time from last study vaccination to the onset of:First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus(regardless of antigenic match), occurring from 14 days after vaccination (ie study day 15) and untilthe end of influenza season, using the protocol-defined ILI definition.
試驗目的
主要療效目的：
1a. 證實含MF59 佐劑的流感疫苗對預防≥ 65 歲成人因任何流感
病毒株造成，且由反轉錄聚合酶連鎖反應(RT-PCR)確診A 型流感及/
或B 型流感疾病的療效，非劣於無佐劑流感疫苗對照品。
非劣性的成功基準：
若相對疫苗療效(rVE)的期中分析(IA)經調整雙尾95%* 信賴區間(CI)
下限值(LL)高於或等於-20%，則證實含MF59 佐劑的流感疫苗
相較於無佐劑流感疫苗對照品的療效為非劣性。
1b. 證實含MF59 佐劑的流感疫苗對預防≥ 65 歲成人因任何流感
病毒株感染，且經RT-PCR 確診A 型流感及/或B 型流感疾病的療效優
於無佐劑流感疫苗對照品。
優效性成功基準：
若rVE 的IA 經調整雙尾95%* CI 的LL 高於0%，則證實含
MF59 佐劑的流感疫苗相對於無佐劑流感疫苗對照品的療效具優
效性。
若使用試驗計畫書定義的類流感疾病(ILI)定義證實達成目的1a，則本
試驗視為成功。
次要療效目的：
1. 評估含MF59 佐劑的流感疫苗相較於無佐劑流感疫苗，
對預防因抗原與針對季節性疫苗選定之病毒株相符的流感病毒株所造
成之A 型流感及/或B 型流感的療效，利用計畫書定義的ILI 定義。
2. 評估含MF59 佐劑的流感疫苗相較於無佐劑流感疫苗，
對預防因任何病毒株且經培養確診A 型流感及/或B 型流感疾病的療
效(無論抗原是否與針對季節性疫苗選用之病毒株相符)，利用計畫書
定義的ILI 定義。
3. 評估含MF59 佐劑的流感疫苗相較於無佐劑流感疫苗，
對預防因任何流感病毒株且經RT-PCR 確診A 型流感及/或B 型流感疾
病之療效的非劣性及優效性，利用經調整的美國疾病管制與預防中心
(CDC) ILI 定義以及世界衛生組織(WHO)的ILI 定義。
4. 評估含MF59 佐劑的流感疫苗相較於無佐劑流感疫苗，
對預防因抗原與針對季節性疫苗選定之病毒株不相符的流感病毒株所
造成之A 型流感及/或B 型流感的療效，利用計畫書定義的ILI 定義。
次要免疫原性目的：
1. 評估含MF59 佐劑的流感疫苗相較於無佐劑流感疫苗的
免疫原性，測量方法為疫苗接種前與接種後21天，對各流感季節內子
組受試者的均質性疫苗株進行HI 檢定法。
次要安全性目的：
1. 評估aQIV 含MF59 佐劑的流感疫苗相較於QIV 無佐劑流感疫苗的
安全性，判斷方法為所有接種試驗疫苗後30 分鐘內通報的不良事件
(AE)、嚴重不良事件(SAE)、導致提前退出試驗的AE 以及整個試驗期
間的特別關注不良事件(AESI)發生率。
藥品名稱
注射乳劑
主成份
Influenza Vaccine, Adjuvanted
劑型
251
劑量
A single 0.5 mL dose for intramuscular injection
評估指標
主要試驗指標及次要試驗指標提供於第8.1 節，試驗指標。
The primary efficacy endpoints are defined as the time from last study vaccination to the onset of:
First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus
(regardless of antigenic match), occurring from 14 days after vaccination (ie study day 15) and until
the end of influenza season, using the protocol-defined ILI definition.
The primary efficacy endpoints are defined as the time from last study vaccination to the onset of:
First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus
(regardless of antigenic match), occurring from 14 days after vaccination (ie study day 15) and until
the end of influenza season, using the protocol-defined ILI definition.
主要納入條件
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
1. Adults of ≥65 years of age on the day of vaccination.
2. Individuals who have voluntarily given written informed consent after the nature of the study
has been explained according to local regulatory requirements, prior to study entry.
3. Individuals who have the ability to comply with study procedures including follow-up
1. Adults of ≥65 years of age on the day of vaccination.
2. Individuals who have voluntarily given written informed consent after the nature of the study
has been explained according to local regulatory requirements, prior to study entry.
3. Individuals who have the ability to comply with study procedures including follow-up
主要排除條件
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
1. Adults of ≥65 years of age on the day of vaccination.
2. Individuals who have voluntarily given written informed consent after the nature of the study
has been explained according to local regulatory requirements, prior to study entry.
3. Individuals who have the ability to comply with study procedures including follow-up
1. Adults of ≥65 years of age on the day of vaccination.
2. Individuals who have voluntarily given written informed consent after the nature of the study
has been explained according to local regulatory requirements, prior to study entry.
3. Individuals who have the ability to comply with study procedures including follow-up
試驗計畫預計收納受試者人數
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台灣人數
1000 人
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全球人數
35800 人
