計劃書編號V116-010
NCT Number(ClinicalTrials.gov Identfier)NCT05569954
試驗已結束
2022-11-01 - 2026-05-31
Phase III
召募中4
一項第3期、隨機分配、雙盲、活性對照藥物對照之臨床試驗，評估V116用於50歲以上未曾接種肺炎鏈球菌疫苗之成人的安全性、耐受性和免疫原性
-
試驗申請者
美商默沙東藥廠股份有限公司台灣分公司
-
試驗委託 / 贊助單位名稱
美商默沙東藥廠股份有限公司台灣分公司
-
臨床試驗規模
多國多中心
-
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
實際收案人數
0 召募中
適應症
肺炎鏈球菌感染症
試驗目的
主要目的
-依據發生不良事件（AE）的受試者比例，評估V116的安全性和耐受性
-比較V116相較於PPSV23在疫苗接種後30天的血清型特異性（serotype-specific）調理吞噬細胞活性（OPA）幾何平均效價（GMT）
-針對V116中的獨特血清型，比較V116相較於PPSV23在疫苗接種30天後的血清型特異性OPA反應自基準期以來升高≥4倍的受試者比例
藥品名稱
注射劑
主成份
21 PnPs of serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B)
CAPSULAR POLYSACCHARIDE PURIFIED
CAPSULAR POLYSACCHARIDE PURIFIED
劑型
Injection
Injection
Injection
劑量
0.5 mL/ syringe (含4 µg of each PnPs antigen, 84µg)
0.5 mL/ syringe
0.5 mL/ syringe
評估指標
• 接種疫苗後第1天至第5天發生之設定記錄的注射部位AE
• 接種疫苗後第1天至第5天發生之設定記錄的全身性AE
• 接種疫苗後第1天至6個月發生之疫苗相關嚴重不良事件（SAE）
• 血清型特異性OPA反應
• 接種疫苗後第1天至第5天發生之設定記錄的全身性AE
• 接種疫苗後第1天至6個月發生之疫苗相關嚴重不良事件（SAE）
• 血清型特異性OPA反應
主要納入條件
若受試者符合下列所有條件，即具有本試驗納入資格：
受試者類型及疾病特徵
1.受試者可患有潛在慢性病症，惟需經試驗主持人判斷評估為穩定。
人口統計資料
2.知情同意時年滿50歲，任何生理性別／社會性別。
女性受試者
3.出生時為女性的受試者若目前未懷孕或餵哺母乳，且符合至少一項下列條件，即具有參與資格：
•不具有生育能力的受試者（POCBP）
或
•具有生育能力的受試者（POCBP），且：
-在接種試驗疫苗期間以及接種最後一劑試驗疫苗後至少6週內，使用一種可接受的避孕方法，或以不進行陰莖-陰道性行為做為其偏好且平常採行的生活方式（長期以及持續禁慾），如試驗計畫書附錄5中所述。試驗主持人應評估避孕方法失敗的可能性（例如：未確實使用避孕方法、近期才開始避孕）與接種第一劑試驗疫苗之間的關聯性。POCBP使用的避孕措施應符合當地關於臨床試驗受試者避孕方法的規定。如果任何試驗疫苗的當地仿單中的避孕要求比上述要求更嚴格，應遵守當地仿單的要求。
-在接種第一劑試驗疫苗前24小時內，使用高靈敏度驗孕方法（尿液或血清，依據當地法規要求）的結果須呈陰性。若尿液驗孕無法確認為陰性（例如：結果不明確），則需要進行血清驗孕。在這種情況，若血清驗孕結果為陽性，則必須將該受試者排除。接種試驗疫苗期間與接種試驗疫苗之後的其他驗孕要求，詳見試驗計畫書第8.3.2節。
-已由試驗主持人檢視受試者的病史、月經史與最近的性生活狀況，以降低納入剛懷孕但未檢出之POCBP的風險。
知情同意
4.受試者（或法定代理人）已為本試驗提供書面知情同意／贊同。受試者也可以提供未來生物醫學研究（FBR）的同意／贊同。然而，受試者可以在不參加未來生物醫學研究的情況下參加本試驗。
其他類別
5.根據試驗主持人的判斷，受試者有能力在未獲協助下完成電子疫苗接種通報卡（eVRC）資料收集。
受試者類型及疾病特徵
1.受試者可患有潛在慢性病症，惟需經試驗主持人判斷評估為穩定。
人口統計資料
2.知情同意時年滿50歲，任何生理性別／社會性別。
女性受試者
3.出生時為女性的受試者若目前未懷孕或餵哺母乳，且符合至少一項下列條件，即具有參與資格：
•不具有生育能力的受試者（POCBP）
或
•具有生育能力的受試者（POCBP），且：
-在接種試驗疫苗期間以及接種最後一劑試驗疫苗後至少6週內，使用一種可接受的避孕方法，或以不進行陰莖-陰道性行為做為其偏好且平常採行的生活方式（長期以及持續禁慾），如試驗計畫書附錄5中所述。試驗主持人應評估避孕方法失敗的可能性（例如：未確實使用避孕方法、近期才開始避孕）與接種第一劑試驗疫苗之間的關聯性。POCBP使用的避孕措施應符合當地關於臨床試驗受試者避孕方法的規定。如果任何試驗疫苗的當地仿單中的避孕要求比上述要求更嚴格，應遵守當地仿單的要求。
-在接種第一劑試驗疫苗前24小時內，使用高靈敏度驗孕方法（尿液或血清，依據當地法規要求）的結果須呈陰性。若尿液驗孕無法確認為陰性（例如：結果不明確），則需要進行血清驗孕。在這種情況，若血清驗孕結果為陽性，則必須將該受試者排除。接種試驗疫苗期間與接種試驗疫苗之後的其他驗孕要求，詳見試驗計畫書第8.3.2節。
-已由試驗主持人檢視受試者的病史、月經史與最近的性生活狀況，以降低納入剛懷孕但未檢出之POCBP的風險。
知情同意
4.受試者（或法定代理人）已為本試驗提供書面知情同意／贊同。受試者也可以提供未來生物醫學研究（FBR）的同意／贊同。然而，受試者可以在不參加未來生物醫學研究的情況下參加本試驗。
其他類別
5.根據試驗主持人的判斷，受試者有能力在未獲協助下完成電子疫苗接種通報卡（eVRC）資料收集。
主要排除條件
Exclusion Criteria:
Has a history of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site] or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1)
Has a known hypersensitivity to any component of V116 or PPSV23, including diphtheria toxoid
Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease
Has a coagulation disorder contraindicating IM vaccination
Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring <72 hours before receipt of study vaccine
Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
Received prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol
Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥14 days before receipt of study vaccine
Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable)
Received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine
Received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 postvaccination blood draw is complete
Has a history of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site] or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1)
Has a known hypersensitivity to any component of V116 or PPSV23, including diphtheria toxoid
Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease
Has a coagulation disorder contraindicating IM vaccination
Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring <72 hours before receipt of study vaccine
Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
Received prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol
Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥14 days before receipt of study vaccine
Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable)
Received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine
Received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 postvaccination blood draw is complete
試驗計畫預計收納受試者人數
-
台灣人數
120 人
-
全球人數
1400 人
