計劃書編號V118_24
NCT Number(ClinicalTrials.gov Identfier)NCT06087640
2023-09-01 - 2026-06-30
Phase III
尚未開始4
召募中1
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四價流感疫苗相較於四價流感疫苗對? 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
2025/08/20
試驗主持人及試驗醫院
實際收案人數
0 尚未開始
實際收案人數
0 尚未開始
適應症
流感疫苗
試驗目的
主要療效目的：
1a. 證實aQIV 對預防? 65 歲成人因任何流感病毒株造成，且由反轉錄聚合?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QIV 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aQIV 相較於QIV 對照品的療效為非劣性。
1b. 證實aQIV 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QIV 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aQIV 相對於QIV 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aQIV 相較於QIV，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aQIV 相較於QIV，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aQIV 相較於QIV，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aQIV 相較於QIV，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aQIV 相較於QIV 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 相較於QIV 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。
探索性目的：
有關探索性目的的更多相關細節，提供於第2.3 節，探索性目的。
藥品名稱
輔流安四價流感疫苗/Fluad Tetra
主成份
輔流安四價流感疫苗/Fluad Tetra
劑型
suspension for injection in pre-filled syringe
劑量
每劑0.5 毫升
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-upIn 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-upIn 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
主要排除條件
Exclusion Criteria:
In order to participate in this study, all subjects must not meet any of the exclusion criteria described below:
Bedridden subjects (i.e. confined to bed by sickness or old age).
Subjects that are incapacitated and because of that in need of a Legally Authorized Representative.
Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study.
Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination.
Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw.
Abnormal function of the immune system resulting from:
Clinical conditions;
Systemic administration of corticosteroids (PO/IV/IM) at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent; Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted;
Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
Receipt of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire study period.
Acute (severe) febrile illness.
Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.
Participation in the current study for more than one season.
In order to participate in this study, all subjects must not meet any of the exclusion criteria described below:
Bedridden subjects (i.e. confined to bed by sickness or old age).
Subjects that are incapacitated and because of that in need of a Legally Authorized Representative.
Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study.
Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination.
Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw.
Abnormal function of the immune system resulting from:
Clinical conditions;
Systemic administration of corticosteroids (PO/IV/IM) at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent; Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted;
Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
Receipt of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire study period.
Acute (severe) febrile illness.
Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.
Participation in the current study for more than one season.
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
