登记号
CTR20221418
相关登记号
曾用名
药物类型
生物制品
临床申请受理号
企业选择不公示
适应症
本品适用于预防60岁及以上的成年人呼吸道合胞病毒引起的下呼吸道疾病
试验通俗题目
一项呼吸道合胞病毒疫苗预防60岁及以上成人下呼吸道疾病的研究
试验专业题目
一项使用基于Ad26.RSV.preF的疫苗预防≥60岁成人中由RSV引起的下呼吸道疾病的随机、双盲、安慰剂对照、3期有效性研究
试验方案编号
VAC18193RSV3001
方案最近版本号
修正案4/中国版修正案5
版本日期
2022-07-18
方案是否为联合用药
否
申请人信息
申请人名称
联系人姓名
杨晓煜
联系人座机
021-33378730
联系人手机号
18818211895
联系人Email
xyang160@its.jnj.com
联系人邮政地址
上海市-上海市-徐汇区桂箐路65号新研大厦6楼
联系人邮编
200233
临床试验信息
试验分类
安全性和有效性
试验分期
III期
试验目的
证明基于Ad26.RSV.preF的研究疫苗与安慰剂相比在预防≥60岁成人经逆转录酶聚合酶链反应（RT-PCR）确认的RSV所致下呼吸道疾病（LRTD）的有效性。
随机化
随机化
盲法
双盲
试验范围
国际多中心试验
设计类型
平行分组
年龄
60岁(最小年龄)至
无上限
(最大年龄)
性别
男+女
健康受试者
有
入选标准
- 必须签署ICF，表明其理解研究的目的、程序及潜在风险和获益并愿意参加研究。
- 愿意并能够遵循本方案规定的禁忌和限制事项。
- 签署ICF当天年龄必须≥60岁，预计能够在研究期间腾出时间。
- 在随机化之前，受试者必须： 绝经后（绝经后状态定义为停经12个月，且无其他医学原因）； 不打算通过任何方法怀孕。 注：子宫切除的受试者也有资格参加研究。
- 受试者在接种疫苗时必须保持稳定的健康状况（根据研究者的临床判断）。某些受试者可能患有高血压、CHF、COPD、2型糖尿病、高脂蛋白血症或甲状腺功能减退症等基础疾病，但只要接种疫苗时研究者判断其症状和体征稳定且医学可控，同时受试者的医疗保健提供机构会对其进行常规随访，这些受试者就有资格参加研究。将根据受试者的病史及其在ICF签署后、疫苗接种前的生命体征决定是否将其纳入研究。 注：第12个月复种时，受试者的健康状况必须保持稳定（根据研究者的判断）。某些受试者可能患有基础疾病，但只要复种时研究者判断其症状和体征稳定且医学可控。
- 同意从疫苗接种开始至接种后3个月不献血。
- 必须能够阅读、理解并完成电子日志中的问卷。
- 必须愿意在研究过程中提供可验证的身份证明、联系方式并愿意与研究者联系。
- 必须能够使用智能手机/平板电脑/计算机。
排除标准
- 患有严重的临床不稳定型疾病（如需要或不需要透析的终末期肾病、临床不稳定型心脏疾病）、阿尔茨海默病或其他任何研究者认为参加研究不符合受试者的最佳利益或可能妨碍、混淆或限制方案特定评估的疾病。
- 筛选或复种前5年内有恶性肿瘤史，但以下情况除外： a. 由研究者决定，可入组患有皮肤鳞状细胞癌和皮肤基底细胞癌以及宫颈原位癌的受试者。 b. 根据研究者的判断，可入组5年内有恶性肿瘤病史但已治愈且复发风险极小的受试者。
- 根据研究者的判断，受试者在疫苗接种前4周内接受过重大手术（如重大心肺或腹部手术），或研究期间无法从之前的手术中完全恢复，或计划在参加研究期间进行重大手术。
- 由以下情况引起的免疫系统功能异常： a. 存在预期会影响研究疫苗诱导的免疫应答的临床状况（例如，自身免疫性疾病或免疫缺陷）。 由研究者决定，可入组在不使用全身性免疫调节剂和糖皮质激素的情况下疾病稳定且非活动性的自身免疫性疾病（例如，自身免疫性甲状腺疾病、自身免疫性炎症性风湿性疾病[如类风湿性关节炎和1型糖尿病]）受试者。 b. 在研究疫苗接种前2个月内和研究期间，长期或反复使用全身性皮质类固醇。有显著免疫抑制作用的类固醇剂量为≥2周每天接受20mg泼尼松或等效药物。 注：允许使用眼用、局部、关节内或吸入性类固醇。 c. 在研究疫苗接种前6个月内和研究期间接受抗肿瘤药和免疫调节剂（例如，癌症化疗药物）或放疗。 注：允许使用眼部和局部抗肿瘤药物和免疫调节剂。
- 接种过或计划接种： a. 获批的减毒活疫苗 - 在计划的研究疫苗接种前后28天内。 b. 其他获批的（非活）疫苗 - 在计划的研究疫苗接种前后14天内。
- 在研究疫苗接种前24小时内出现急性疾病（包括急性呼吸道疾病）或体温≥37.0℃（腋温）。 注：允许延后入组。
- 有重大精神疾病和/或药物或酒精滥用，研究者认为会损害受试者的安全性和/或研究程序依从性。
- 已知或疑似对疫苗或疫苗组分（包括研究疫苗的任何成分）过敏或有速发过敏反应史或其他严重不良反应史。请参见Ad26/蛋白preF RSV疫苗最新版研究者手册 (IB Ad26/protein preF RSV vaccine 2021)及研究者手册增补（如适用）。
- 有急性多发性神经病（例如，格林巴利综合征）史或慢性特发性脱髓鞘性多发神经病（CIDP）史。
- 病史显示接受过造血干细胞移植，在计划的研究疫苗接种前2个月内接受过免疫球蛋白治疗，前12个月内接受过RSV、hMPV或副流感病毒特异性免疫球蛋白治疗，前4个月内接受过血液单采或血液制品治疗，或计划在研究期间接受上述治疗。 注：允许在研究疫苗给药前和研究实施期间使用单抗药物，靶向T细胞（抗CD3、CD4、CD33和CD52）、B细胞（抗CD45、CD19、CD20、CD22、CD27、CD38和CD138）和检查点抑制剂（PD-1、PDL-1和CTLA-4）的单抗除外。禁用的单抗有：莫罗单抗-CD3（Muromonab-CD3）、吉妥单抗（gemtuzumab ozogamicin）、阿仑单抗、贝伐单抗、利妥昔单抗、奥法木单抗、奥珠单抗、托西莫单抗、维妥珠单抗（veltuzumab）、奥滨尤妥珠单抗（obinutuzumab）、依帕珠单抗、派姆单抗、纳武单抗、阿特珠单抗、阿维鲁单抗（avelumab）、度伐利尤单抗（durvalumab）和靶向伊匹木单抗的CTLA-4。在计划的研究疫苗给药前2个月内接受了这些单抗的受试者或计划在研究期间接受这些单抗的受试者将被排除在研究之外。
- 在计划的研究疫苗接种前30天内接受过试验用药物或使用过侵入性试验用医疗器械，前6个月内接受过试验用疫苗，或目前已入组或计划在本研究期间参加另一项临床研究。 注：经申办方或其代表批准后，可入组正在参加观察性临床研究（即无干预）或干预性研究观察期的受试者。
- 有肌内注射和采血禁忌（例如，出血性疾病）。
- 在既往RSV疫苗研究中接种过RSV疫苗。
- 按照修正案1将此标准删除
- 为研究者或研究中心的雇员，会直接参与本研究或本研究研究者或研究中心负责的其他研究，或为这些雇员或研究者的家属，或为申办方的雇员。
- 研究者认为受试者不太可能依从研究要求或不太可能完成整个接种和观察过程。
- 无法与研究者进行可靠的沟通。
- 受试者双臂三角肌区域存在明显瘢痕、纹身、擦伤、割伤或感染，研究者认为可能干扰注射部位局部反应评价。
- 接种过或计划接种SARS-CoV-2疫苗： a 减毒SARS-CoV-2活疫苗（在计划的研究疫苗首次或后续接种前后28天内接种）。 b 非活SARS-CoV-2活疫苗（在计划的研究疫苗首次或后续接种前后14天内接种）。 c 病毒载体SARS-CoV-2疫苗（在计划的研究疫苗首次或后续接种前后28天内接种）。
- 在随机化前至每次研究疫苗接种后28天内的任何时间接种了或计划接种Ad26载体疫苗（不适用于SARS-CoV-2疫苗；请参见排除标准19）。
- 有TTS或肝素诱导性血小板减少症和血栓形成（HITT）病史。 注：研究者应确保在首次接种之前受试者满足所有研究入组标准。如果筛选后至研究疫苗接种前受试者的临床状态发生改变（包括任何已有的实验室检查结果或者收到更多医疗记录显示改变），导致其不再符合所有入排标准，那么该受试者将被排除在研究之外。支持满足入组标准的所需文件参见附录2：监管、伦理和研究监督考量中的“源文件”。
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:预防性呼吸道合胞病毒疫苗 (Ad26/蛋白preF RSV疫苗)
|
剂型:注射剂
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:Ad26.RSV.preF和RSV preF蛋白的安慰剂
|
剂型:注射剂
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 发生经逆转录聚合酶链反应（RT-PCR）确认的呼吸道合胞体病毒（RSV）所致下呼吸道疾病（LRTD）的受试者百分比 | 直到19个月 | 有效性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 在第一个RSV季节期间，发生任何经RT-PCR确认的RSV所致ARI的百分比 | 直到9个月 | 有效性指标 |
| 在整个研究期间，经RT-PCR确认的RSV所致LRTD的受试者百分比 | 直到21个月 | 有效性指标 |
| 在整个研究中，RT-PCR 确认 RSV 介导的急性呼吸道感染 (ARI) 的参与者百分比 | 直到21个月 | 有效性指标 |
| 严重不良事件（SAE）的发生率 | 直到21个月 | 安全性指标 |
| 特别关注的不良事件（AESI）的发生率 | 直到21个月 | 安全性指标 |
| 有征集性局部不良事件（AE）的发生率 | 接种7天后（第8天到第373天） | 安全性指标 |
| 有征集性全身 AE 的受试者百分比 | 接种7天后（第8天和第373天） | 安全性指标 |
| 非征集性AE的发生率 | 接种28天后（第29天和第393天） | 安全性指标 |
| RSV 中和抗体水平 | 直到21个月 | 有效性指标 |
| 通过酶联免疫吸附测定（ELISA）的RSV前F蛋白和后F蛋白结合抗体 | 直到21个月 | 有效性指标 |
| 干扰素 γ （IFN-γ） 酶联免疫斑 （ELISpot） 测定 | 直到21个月 | 有效性指标 |
数据安全监察委员会（DMC）
有
为受试者购买试验伤害保险
有
研究者信息
| 姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 | |
|---|---|---|---|---|---|---|---|
| 朱凤才 | 医学硕士 | 主任医师 | 13851994867 | jszfc@jscdc.cn | 江苏省-南京市-南京市江苏路172号 | 210009 | 江苏省疾病预防控制中心 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| 江苏省疾病预防控制中心 | 朱凤才 | 中国 | 江苏省 | 南京市 |
| Paratus Clinical Kanwal Clinic | Kim, Joshua | Australia | New South Wales | Kanwal |
| Northside Health | Voloshyna, Olga | Australia | New South Wales | Coffs Harbour |
| Paratus Clinical Canberra Clinic | Leah, Amber | Australia | Austl. Cap. Terr. | Bruce |
| Mater Hospital Brisbane | Griffin, Paul | Australia | Queensland | South Brisbane |
| CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos | Barranjard Vannucci Lomonte, Andrea | Brazil | Sao Paulo | Sao Paulo |
| CMiP - Centro Mineirode Pesquisa | de Souza, Rodrigo Daniel | Brazil | Minas Gerais | Juiz de Fora |
| FACULDADE DE MEDICINA DO ABC | Fiss, Elie | Brazil | Sao Paulo | Santo Andre |
| CEMEC - Centro Multidisciplinar de Estudos Clinicos | Francisco Pez, Andreia Luisa | Brazil | Sao Paulo | Sao Bernardo do Campo |
| UFRR - Universidade Federal de Roraima | Jardim da Fonseca, Allex | Brazil | Roraima | Boa Vista |
| Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto | Lacerda Nogueira, Mauricio | Brazil | Sao Paulo | Sao Jose do Rio Preto |
| HOSPITAL DE CLINICAS DE PORTOALEGRE | Zubaran Goldani, Luciano | Brazil | Rio Grande do Sul | Porto Alegre |
| Nucleo de Medicina Tropical - Universidade Federal do Ceara | Castelo Branco Coelho, Ivo | Brazil | Ceara | Fortaleza |
| CPQuali Pesquisa Clinica LTDA ME | Delano Bronstein, Marcello | Brazil | Sao Paulo | Sao Paulo |
| Hospital Gloria D'Or -Hospitais Integrados da Gavea S/A | Cerbino Neto, Jose | Brazil | Rio de Janeiro | Rio de Janeiro |
| Hospital Sao Lucas da PUCRS | Ramos, Fabiano | Brazil | Rio Grande do Sul | Porto Alegre |
| LMC Clinical Research dba Manna Research Inc. Quebec City | Blouin, Francois | Canada | Quebec | Levis |
| LMC Clinical Research dba Manna Research Inc. Montreal | Garg, Naveen | Canada | Quebec | Pointe Claire |
| LMC Clinical Research dba Manna Research Inc. Toronto | Vale, Noah | Canada | Ontario | Toronto |
| LMC Clinical Research dba Manna Research Inc. Burlington | Salter, Timothy | Canada | Ontario | Burlington |
| LMC Clinical Research Inc. (Bayview) | Abitbol, Alexander | Canada | Ontario | Toronto |
| DIEX Recherche Victoriaville Inc. | Bellavance, Ethel | Canada | Quebec | Victoriaville |
| DIEX Recherche Quebec Inc. | Frechette, Andre | Canada | Quebec | Quebec |
| DIEX Recherche Sherbrooke Inc. | Girard, Ginette | Canada | Quebec | Sherbrooke |
| Okanagan Clinical Trials | Maytham, Colleen | Canada | British Columbia | Kelowna |
| DIEX Recherche Joliette Inc. | Paquette, Jean Sebastien | Canada | Quebec | Saint-Charles-Borromee |
| CENRESIN | Pavie, Juana Rosa | Chile | NA | Quilota |
| Centro de Estudios Clinicos e Investigacion Medica (CeCim) | Saavedra Pacheco, Carla Constanza | Chile | Region Met | Santiago |
| Centro de Investigacion del Maule | Silva Orellana, Rafael | Chile | NA | Talca |
| Clinical Research Centre | Poder, Airi | Estonia | NA | Tartu |
| OU Innomedica | Talli, Jaak | Estonia | NA | Tallinn |
| Center for Clinical and Basic Research | Valter, Ivo | Estonia | NA | Tallinn |
| Jarvenpaan rokotetutkimusklinikka | Peltonen, Lauri | Finland | NA | Jarvenpaa |
| Turun rokotetutkimusklinikka | Seppa, Ilkka | Finland | NA | Turku |
| Etela-Helsingin rokotetutkimusklinikka | Koski, Susanna | Finland | NA | Helsinki |
| Oulun rokotetutkimusklinikka | Kokko, Satu | Finland | NA | Oulu |
| Seinajoen rokotetutkimusklinikka | Laajalahti, Outi | Finland | NA | Seinajoki |
| Kokkolan rokotetutkimusklinikka | Paavola, Pauliina | Finland | NA | Kokkola |
| Porin rokotetutkimusklinikka | Seppa, Ilkka | Finland | NA | Pori |
| Tampereen rokotetutkimusklinikka | Seppa, Ilkka | Finland | NA | Tampere |
| Ita-Helsingin rokotetutkimusklinikka | Koski, Susanna | Finland | NA | Helsinki |
| Espoon rokotetutkimusklinikka | Ukkonen, Benita | Finland | NA | Espoo |
| North Manchester General Hospital | Uriel, Alison | United Kingdom Of Great Britain And Northern Ireland | Greater Manchester | Manchester |
| Synexus Hexham General Hospital | Iyengar, Shalini | United Kingdom Of Great Britain And Northern Ireland | Northumberland | Hexham |
| Synexus Midlands Clinical Research Centre | Faulkner, Karen | United Kingdom Of Great Britain And Northern Ireland | West Midlands | Birmingham |
| Synexus Merseyside Clinical Research Centre | Ozunlu, Pembe | United Kingdom Of Great Britain And Northern Ireland | Merseyside | Liverpool |
| Synexus Scotland Clinical Research Centre | Munsoor, Imrozia | United Kingdom Of Great Britain And Northern Ireland | North Lanarkshire | Glasgow |
| Synexus Wales Clinical Research Center | Nicholls, Helen | United Kingdom Of Great Britain And Northern Ireland | South Glamorgan | Cardiff |
| Synexus Lancashire Clinical Research Centre | Munthali, Chigomezgo | United Kingdom Of Great Britain And Northern Ireland | Lancashire | Chorley |
| Synexus Manchester Clinical Research Center | Viljoen, Marianne | United Kingdom Of Great Britain And Northern Ireland | Greater Manchester | Manchester |
| FutureMeds Bridle Clinic | Johnson, Martin | United Kingdom Of Great Britain And Northern Ireland | Merseyside | Bromborough |
| Panthera Biopartners | Rooney, Patrick | United Kingdom Of Great Britain And Northern Ireland | Strathclyde | Glasgow |
| Bradford Royal Infirmary | Saralaya, Dinesh | United Kingdom Of Great Britain And Northern Ireland | West Yorkshire | Bradford |
| Panthera Biopartners | Wickens, Olivia | United Kingdom Of Great Britain And Northern Ireland | Lancashire | Preston |
| FutureMeds Soho Health Centre | Johnson, Martin | United Kingdom Of Great Britain And Northern Ireland | West Midlands | Birmingham |
| Southern Clinical Trials, Christchurch | Carson, Simon | New Zealand | NA | Christchurch |
| Optimal Clinical Trials | Montgomery, Barnaby | New Zealand | NA | Auckland |
| Southern Clinical Trials, Waitemata | Smith, Susan | New Zealand | NA | Auckland |
| Lakeland Clinical Trials | Williams, Michael | New Zealand | NA | Rotorua |
| Southern Clinical Trials Tasman | Thurlow, Claire | New Zealand | NA | Main Road Stoke |
| Southern Clinical Trials Totara Clinical Research | King, Craig | New Zealand | NA | Auckland |
| P3 Research Limited Kapiti | Edwards, Andrew | New Zealand | NA | Paraparaumu |
| Lakeland Clinical Trials | Hemi, Tiwini | New Zealand | NA | Hamilton |
| Lakeland Clinical Trials | Humphrey, Tim | New Zealand | NA | Upper Hutt |
| P3 Research Ltd | Esquilant, Emma | New Zealand | NA | Havelock North |
| P3 Research Ltd | Kamerbeek, Jackie | New Zealand | NA | Tauranga |
| P3 Reaearch Wellington | Quinn, Dean | New Zealand | NA | Wellington |
| P3 Research Ltd | Edwards, Andrew | New Zealand | NA | Palmerston North |
| Synexus Polska Sp. z o.o. Oddzial w Warszawie | Dabrowska, Magda | Poland | NA | Warszawa |
| Synexus Polska Sp. z o.o. Oddzial w Gdansku | Cesarz, Marek | Poland | NA | Gdansk |
| Synexus Polska Sp. z o.o. Oddzial w Czestochowie | Janowicz, Anna | Poland | NA | Czestochowa |
| Synexus Polska Sp. z.o.o. Oddzial w Poznaniu | Kolodziejska, Elzbieta | Poland | NA | Poznan |
| Synexus Polska Sp. z o.o. | Olszewska-Jander, Magdalena | Poland | NA | Lodz |
| Synexus Polska Sp. z o.o. Oddzial w Katowicach | Sipinska-Surzynska, Malgorzata | Poland | NA | Katowice |
| Synexus Polska Sp. z o.o. Oddzial we Wroclawiu | Szymkowiak, Katarzyna | Poland | NA | Wroc？aw |
| KO-MED Centra Kliniczne Zamosc | Czochra, Wojciech | Poland | NA | Zamosc |
| KO-MED Centra Kliniczne Staszow | Wawrzyniec, Katarzyna | Poland | NA | Staszow |
| KO-MED Centra Kliniczne Pu？awy | Konieczny, Marek | Poland | NA | Pulawy |
| KO-MED Centra Kliniczne LUBLIN | Zelazowska, Katarzyna | Poland | NA | Lublin |
| Synexus Scm Sp. Z o.o. Oddzial Gdynia | Sein Anand, Izabela | Poland | NA | Gdynia |
| Centrum Medyczne Pratia Poznan | Kwiatek, Michal | Poland | NA | Skorzewo |
| Centrum Medyczne PRATIA Bydgoszcz | Losinska, Lucyna | Poland | NA | Bydgoszcz |
| Srinagarind Hospital | Meesing, Atibordee | Thailand | Muang | Khon Kaen |
| King Chulalongkorn Memorial Hospital | Tantawichien, Terapong | Thailand | Bangkok | Pathumwan |
| The Vaccine Trial Center(VTC), Faculty of Tropical Medicine | Muangnoicharoen, Sant | Thailand | Ratchathewi | Bangkok |
| Royal Thai Army,Afrims | Nitayaphan, Sorachai | Thailand | Bangkok | Rajathevi |
| Maharaj NakornChiang Mai hospital -Faculty of Medicine | Angkurawaranon, Chaisiri | Thailand | Chiang Mai | Muang |
| Siriraj Hospital | Chayakulkeeree, Methee | Thailand | Bangkok | Bangkok |
| Medpharmics, LLC | Jeanfreau, Robert | United States Of America | Louisiana | Kenner |
| Paradigm Clinical Research Centers, Inc. | Lupercio, Rafael | United States Of America | California | Redding |
| Rapid Medical Research | Briskin, Toby | United States Of America | Ohio | Cleveland |
| Regional Clinical Research, Inc. | Patel, Suchet | United States Of America | New York | Endwell |
| Avail Clinical Research, LLC | Rankin, Bruce | United States Of America | Florida | Deland |
| Advanced Clinical Research | Turner, Mark | United States Of America | Idaho | Boise |
| Meridian Clinical Research, LLC | Harper, Charles | United States Of America | Nebraska | Norfolk |
| MedPharmics - Biloxi | Matherne, Paul | United States Of America | Gulfport | Biloxi |
| Medication Management, LLC | Pharr, Walter | United States Of America | North Carolina | Greensboro |
| Jacksonville Center For Clinical Research | Jacqmein, Jeffry | United States Of America | Florida | Jacksonville |
| Hope Research Institute | Burgher, Abram | United States Of America | Arizona | Peoria |
| Advanced Clinical Research | Lucksinger, Gregg | United States Of America | Texas | Cedar Park |
| Meridian Clinical Research, LLC | Bradley, Paul | United States Of America | Georgia | Savannah |
| Harmony Clinical Research Inc | Debs-Perez, Giselle | United States Of America | Florida | North Miami Beach |
| Westside Center for Clinical Research | Downey, Herman | United States Of America | Florida | Jacksonville |
| Meridian Clinical Research, LLC | Eder, Frank | United States Of America | New York | Endwell |
| Meridian Clinical Research - Dakota Dunes | Ensz, David | United States Of America | Iowa | Dakota Dunes |
| Meridian Clinical Research - Omaha | Essink, Brandon | United States Of America | Nebraska | Omaha |
| Omega Medical Research | Fried, David | United States Of America | Rhode Island | Warwick |
| Lynn Health Science Institute | Griffin, Carl | United States Of America | Oklahoma | Oklahoma City |
| Wake Research Associates | Hong, Matthew | United States Of America | North Carolina | Raleigh |
| Synexus Clinical Research US, Inc | Adams, Michael | United States Of America | Utah | Murray |
| Clinical Research Consortium Arizona | Anderson, Corey | United States Of America | Arizona | Tempe |
| Optimal Research | Brune, Daniel | United States Of America | Illinois | Peoria |
| Synexus Clinical Research US, Inc | Severance, Randall | United States Of America | Arizona | Chandler |
| Synexus Clinical Research US, Inc | McGill, Lorrie | United States Of America | Nebraska | Omaha |
| Optimal Research | Kimmel, Murray | United States Of America | Florida | Melbourne |
| Synexus Clinical Research US, Inc | Starkey, Thomas | United States Of America | Colorado | Aurora |
| Heartland Clinical Research | Poling, Terry | United States Of America | Kansas | Wichita |
| Clinical Research Associates Inc | Sharp, Stephan | United States Of America | Tennessee | Nashville |
| Optimal Research | Ghosh, Rita | United States Of America | Maryland | Rockville |
| Heartland Research Associates, LLC | Rausch, Michael | United States Of America | Kansas | Augusta |
| The Center for Pharmaceutical Research (CPR) | Ervin, John | United States Of America | Missouri | Kansas City |
| Optimal Research | Middleton, Randle | United States Of America | Alabama | Huntsville |
| Synexus Clinical esearch US, Inc | Nugent, Paul | United States Of America | Ohio | Cincinnati |
| Central Phoenix Medical Clinic | Riffer, Ernie | United States Of America | Arizona | Phoenix |
| Coastal Carolina Research Center | Tangeman, Cayce | United States Of America | South Carolina | Mt. Pleasant |
| Synexus Clinical Research US, Inc | Choi, Melissa | United States Of America | Minnesota | Richfield |
| Synexus Clinical Research US, Inc | Tharenos, Leslie | United States Of America | Missouri | St Louis |
| Optimal Research | Yassini, Patrick | United States Of America | California | San Diego |
| Heartland Research Associates, LLC | Glover, Richard | United States Of America | Kansas | Newton |
| DM Clinical Research | Irfan, Muhammad | United States Of America | Texas | Tomball |
| The Iowa Clinic, P.C. | Jones, Kathleen | United States Of America | Iowa | West Des Moines |
| Martine Diagnostic Clinic | Martin, Earl | United States Of America | Texas | Tomball |
| Medpharmics, LLC | Plimpton, Charles | United States Of America | Arizona | Phoenix |
| Synexus Clinical Research US, Inc | Klein, Jeffrey | United States Of America | Ohio | Akron |
| Optimal Research | Vachris, Timothy | United States Of America | Texas | Austin |
| Synexus Clinical Research US, Inc | Meyer, Robert | United States Of America | Florida | Orlando |
| Trial Management Associates, LLC | Williams, Barton | United States Of America | North Carolina | Wilmington |
| PMG Research of Wilmington, LLC | Cannon, Kevin | United States Of America | North Carolina | Wilmington |
| Clinical Research Associates of Tidewater | Ellis, Kimberly | United States Of America | Virginia | Norfolk |
| Spartanburg Medical Research | Fogarty, Charles | United States Of America | South Carolina | Spartanburg |
| Paradigm Clinical Research Centers, Inc. | Elzi, Stanton | United States Of America | Colorado | Wheat Ridge |
| Prestige Clinical Research Center, Inc. | Junquera, Patricia | United States Of America | Florida | Coral Gables |
| Rancho Paseo Medical Group | Kasarjian, Julie | United States Of America | California | Banning |
| Heartland Clinical Research | Egelhof, Richard | United States Of America | Kansas | Wichita |
| Lynn Institute of Norman | Cox, Steven | United States Of America | Oklahoma | Norman |
| Suncoast Research Group | Kutner, Mark | United States Of America | Florida | Miami |
| Texas Center for Drug Development, Inc | Miller, Vicki | United States Of America | Texas | Houston |
| Central Kentucky Research Associates,Inc. | Adams, Mark | United States Of America | Kentucky | Lexington |
| Synexus Clinical Research US, Inc | Taylor, David | United States Of America | Georgia | Atlanta |
| Johnson County Clin-Trials | Fierro, Carlos | United States Of America | Kansas | Lenexa |
| Centennial Medical Group | Geller, Steven | United States Of America | Maryland | Elkridge |
| New Horizons Clinical Research | Powell, Richard | United States Of America | Ohio | Cincinnati |
| PMG Research of Bristol | Grunstra, Bernard | United States Of America | Tennessee | Bristol |
| Clinical Research Consortium, an AMR company | Jacobs, Michael | United States Of America | Nevada | Las Vegas |
| Synexus Clinical Research US, Inc | Jennings, William | United States Of America | Texas | San Antonio |
| PMG Research of Charleston, LLC | Mills, Richard | United States Of America | South Carolina | Mount Pleasant |
| Tekton Research Inc. | Pickrell, Paul | United States Of America | Texas | Austin |
| Preferred Primary Care Physicians Research | Purighalla, Raman | United States Of America | Pennsylvania | Pittsburgh |
| Tekton Research Inc. | Lockwood, Robert | United States Of America | Oklahoma | Yukon |
| Advanced Clinical Research | Rizzardi, Barbara | United States Of America | Utah | West Jordan |
| Clinical Research of South Florida, an AMR Company | Rosen, Jeffrey | United States Of America | Florida | Coral Gables |
| Velocity Clinical Research, Hallandale Beach | Vijil, Julio | United States Of America | Florida | Hallandale Beach |
| Clinical Research Atlanta | Finley, Jon | United States Of America | Georgia | Stockbridge |
| Coastal Clinical Research, Inc | Studdard, Harry | United States Of America | Alabama | Mobile |
| Sundance Clinical Research | Wadsworth, Larkin | United States Of America | Missouri | St. Louis |
| Compass Research LLC | Jenouri, Gilbert | United States Of America | Florida | Leesburg |
| JEM Research, LLC | Bush, Larry | United States Of America | Florida | Atlantis |
| Synexus Clinical Research US, Inc | Calinescu, Cornell | United States Of America | Nevada | Henderson |
| Medpharmics, LLC | Carr, Quito Osuna | United States Of America | New Mexico | Albuquerque |
| Synexus Clinical Research US, Inc | DeGrauw, Jeffery | United States Of America | Utah | Layton |
| VitaLink Research Spartanburg | Feldman, Gregory | United States Of America | South Carolina | Spartanburg |
| Synexus Clinical Research US, Inc | Greiwe, Cathy | United States Of America | Ohio | Columbus |
| Amherst Family Practice, PC | Houser, Patricia | United States Of America | Virginia | Winchester |
| Synexus Clinical Research US, Inc | Kirby, William | United States Of America | Alabama | Birmingham |
| Synexus Clinical Research US, Inc | Kopp, James | United States Of America | South Carolina | Anderson |
| Synexus Clinical Research US, Inc | Murray, Linda | United States Of America | Florida | Pinellas Park |
| Synexus Clinical Research US, Inc | Newberg, Joseph | United States Of America | Illinois | Chicago |
| Synexus Clinical Research US, Inc | Pounds, Kevin | United States Of America | Arizona | Tucson |
| Synexus Clinical Research US, Inc | Reynolds, Michele | United States Of America | Texas | Dallas |
| AMR Fort MyersClinical Physiology Associates, an AMR company | Ylisastigui, Pedro | United States Of America | Florida | Ft. Myers |
| Christie Clinic | Bartlett, Andrew | United States Of America | Illinois | Champaign |
| Headlands Research Orlando | Galloway, Christopher | United States Of America | Florida | Orlando |
| Preferred Primary Care Physicians Research | Hartley, Paul | United States Of America | Pennsylvania | Uniontown |
| Spectrum Medical, Inc | Jannach, Stephan | United States Of America | Virginia | Danville |
| Accellacare Research of Cary | Rubino, John | United States Of America | North Carolina | Raleigh |
| Centex Studies, Inc. | Whatley, Joshua | United States Of America | Louisiana | Lake Charles |
| Accellacare Research of Cary | Shoffner, Sylvia | United States Of America | North Carolina | Cary |
| VGR & NOCCR -Knoxville | Smith, William | United States Of America | Tennessee | Knoxville |
| Accellacare Research of Cary | Wilson, Jonathan | United States Of America | North Carolina | Winston-Salem |
| Encompass Clinical Research | Audish, Hanid | United States Of America | California | Spring Valley |
| Synexus Clinical Research US, Inc | Bahrami, Ghazaleh | United States Of America | California | Cerritos |
| Clinical Trials ofTexas, Inc | Denham, Douglas | United States Of America | Texas | San Antonio |
| Health Research of Hampton Roads, Inc | Freeman, George | United States Of America | Virginia | Newport News |
| The South Bend Clinic Center for Research | Harris, James | United States Of America | Indiana | South Bend |
| Synexus Clinical Research US, Inc | Nunez, Margarita | United States Of America | New York | Manhattan |
| Clinical Research Institute of Southern Oregon, P.C. | Delgado, John | United States Of America | Oregon | Grants Pass |
| Central Maine Medical Center | Rohr, Kathryn | United States Of America | Maine | Lewiston |
| Healthcare Clinical Data Inc. | Chavoustie, Steven | United States Of America | Florida | North Miami |
| AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company | Noveck, Robert | United States Of America | Louisiana | New Orleans |
| Clinical Research Institute of Southern Oregon, P.C. | Smiley, Sarah | United States Of America | Oregon | Medford |
| eStudySite | Waters, Michael | United States Of America | California | Chula Vista |
| Buynak Clinical Research | Buynak, Robert | United States Of America | Indiana | Valparaiso |
| Velocity Clinical Research, San Diego | Overcash, Jeffrey Scott | United States Of America | California | La Mesa |
| Baptist Health Center for Clinical Research | Wijewardane, Priyantha | United States Of America | Arkansas | Little Rock |
| Sandhill Research | Lefebvre, Gigi | United States Of America | Florida | St. Petersburg |
| Research Your Health | Adelglass, Jeffrey | United States Of America | Texas | Plano |
| Medpharmics, LLC | Atwi, Jibran | United States Of America | Louisiana | Lafayette |
| Tekton Research Inc. | Bell, Robert | United States Of America | Texas | Beaumont |
| Velocity Clinical Research, Inc. | Chang, Margaret | United States Of America | Florida | Edgewater |
| Medisphere Medical Research Center, Llc | Reyes, Hubert | United States Of America | Indiana | Evansville |
| Synexus Clinical Research US, Inc | Pereira, Isabel | United States Of America | California | Vista |
| Tekton Research Inc. | McDonald, Jara | United States Of America | Texas | San Antonio |
| Mercury Street Medical Group, PLLC | Pullman, John | United States Of America | Montana | Butte |
| Tekton Research Inc. | Thakor, Michael | United States Of America | Colorado | Fort Collins |
| Finger Lakes Clinical Research | Whalen, James | United States Of America | New York | Rochester |
| Hope Research Institute | Joshi, Dhiresh | United States Of America | Nevada | Las Vegas |
| Accel Research Sites | Chronos, Nicolas | United States Of America | Georgia | Eatonton |
| Pharmax ResearchClinic Inc | Paez, Henry | United States Of America | Florida | Miami |
| Atlanta Center for Medical Research | Riesenberg, Robert | United States Of America | Georgia | Atlanta |
| Tulane University School of Medicine | Delafontaine, Patrice | United States Of America | Louisiana | New Orleans |
| Clinical Trials of America | Guillory, Clinton | United States Of America | Louisiana | Monroe |
| Monroe Biomedical Research | Igbinadolor, Awawu | United States Of America | North Carolina | Monroe |
| Palm Beach Research Center | Baron, Mira | United States Of America | Florida | West Palm Beach |
| Velocity Clinical Research, Inc. | Erb, David | United States Of America | South Carolina | Gaffney |
| Clinical NeuroScience Solutions, Inc | Dever, Michael | United States Of America | Florida | Orlando |
| Health Awareness inc. | Surowitz, Ronald | United States Of America | Florida | Jupiter |
| American Health Network, LLC | Spangenthal, Selwyn | United States Of America | North Carolina | Charlotte |
| Vilo Research Group Inc | Zepeda, Luis | United States Of America | Texas | Houston |
| University of Louisville | Arnold, Forest | United States Of America | Kentucky | Louisville |
| Wayne State University | Kilgore, Paul | United States Of America | Michigan | Detroit |
| North Texas Infectious Diseases Consultants | Sandkovsky, Uriel | United States Of America | Texas | Dallas |
| Cope Family Medicine- Ogden Clinic | Peterson, Bryce | United States Of America | Utah | Bountiful |
| Richmond Behavioral Associates | DiBuono, Mark | United States Of America | New York | Staten Island |
| Harlem Hospital Center | Mannheimer, Sharon | United States Of America | New York | New York |
| Jefferson City Medical Group Family | Carr, George | United States Of America | Missouri | Jefferson |
| TREAD Research Tygerberg Hospital | Burgess, Lesley | South Africa | Western Cape | Cape Town |
| Josha Research | Lombaard, Johannes | South Africa | Free State | Bloemfontein |
| Newtown Clinical Research | Mitha, Essack | South Africa | Gauteng | Newtown |
| Synexus Watermeyer | Mkhize, Nontokozo | South Africa | Gauteng | Pretoria |
| Tiervlei Trial Centre | Mohamed, Zarinah | South Africa | Western Cape | Cape Town |
| TASK Central | Govender, Thirumani | South Africa | Western Cape | Cape Town |
| Synexus Helderberg Clinical Research Centre | Roux, Susanna | South Africa | Western Cape | Cape Town |
| Stanza Clinical Research Centre : Mamelodi | Kotze, Sheena | South Africa | Gauteng | Mamelodi East |
| DJW Research | Jurgens, Jaco | South Africa | Gauteng | Krugersdorp |
| Allergy Immunology Unit | Peter, Jonathan | South Africa | Western Cape | Cape Town |
| Be Part Yoluntu Centre | Hellstrom, Elizabeth | South Africa | Western Cape | Paarl |
| Madibeng Centre for Research | Louw, Cheryl | South Africa | North West | Brits |
| Paarl Research Centre | Blignaut, Suzanne | South Africa | Western Cape | Paarl |
| The Aurum Institute Rustenburg Clinical Research Site | Brumskine, William | South Africa | North West | Rustenburg |
| Iatros International | Fourie, Nyda | South Africa | Free State | Bloemfontein |
| Worthwhile Clinical trials | Hussen, Nazreen | South Africa | Gauteng | Johannesburg |
| REIMED Vosloorus | Mabale, Primrose | South Africa | Gauteng | Vosloorus |
| CRISMO Bertha Gxowa Research Centre | Mamba, Musawenkosi | South Africa | Gauteng | Johannesburg |
| TASK Central | Snyman, Elizma | South Africa | Western Cape | George |
| Global Clin Trials Pretoria | Pillay Ramaya, Larisha | South Africa | Gauteng | Pretoria |
| Clinresco Centres Pty Ltd | Rosa, Jennifer | South Africa | Gauteng | Johannesburg |
| Welkom Clinical Trial Centre | Wilhase, Agatha | South Africa | Free State | Welkom |
| 射阳县疾病预防控制中心 | 朱凤才 | 中国 | 江苏省 | 盐城市 |
| 阜宁县疾病预防控制中心 | 朱凤才 | 中国 | 江苏省 | 盐城市 |
| 滨海县疾病预防控制中心 | 朱凤才 | 中国 | 江苏省 | 盐城市 |
| 邳州市疾病预防控制中心 | 朱凤才 | 中国 | 江苏省 | 徐州市 |
| 新沂市疾病预防控制中心 | 朱凤才 | 中国 | 江苏省 | 徐州市 |
| 东海县疾病预防控制中心 | 朱凤才 | 中国 | 江苏省 | 连云港市 |
| Taipei Veterans General Hospital | Chen, Yuh-Min | 中国台湾 | 台湾 | 台北市 |
| Tri-Service General Hospital | Wang, Ning-Chi | 中国台湾 | 台湾 | 台北市 |
| Chang Gung Memorial Hospital, Linkou | Cheng, Huey-Shinn | 中国台湾 | 台湾 | 桃园市 |
| National Taiwan University Hospital | Huang, Kuo-Chin | 中国台湾 | 台湾 | 台北市 |
| China Medical University Hospital | Lin, Chih-Hsueh | 中国台湾 | 台湾 | 新竹市 |
| Taipei Medical University Hospital | Liu, Ming-Che | 中国台湾 | 台湾 | 台北市 |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Lu, Po-Liang | 中国台湾 | 台湾 | 高雄市 |
| Taipei Municipal Wanfang Hospital Managed by Taipei Medical University | Ou, Tsong-Yih | 中国台湾 | 台湾 | 台北市 |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 江苏省疾病预防控制中心伦理审查委员会 | 同意 | 2022-04-29 |
| 江苏省疾病预防控制中心伦理审查委员会 | 同意 | 2022-07-22 |
| 江苏省疾病预防控制中心伦理审查委员会 | 同意 | 2022-08-05 |
| 江苏省疾病预防控制中心伦理审查委员会 | 同意 | 2022-09-28 |
| 江苏省疾病预防控制中心伦理审查委员会 | 同意 | 2022-09-28 |
| 江苏省疾病预防控制中心伦理审查委员会 | 同意 | 2023-02-28 |
试验状态信息
试验状态
主动终止
目标入组人数
国内: 3600 ；
国际: 23000 ；
已入组例数
国内: 2001 ；
国际: 23066 ；
实际入组总例数
国内: 2001 ；
国际: 23066 ；
第一例受试者签署知情同意书日期
国内：2022-08-08；
国际：2021-07-21；
第一例受试者入组日期
国内：2022-08-08；
国际：2021-07-21；
试验终止日期
国内：2023-03-28；
国际：2023-03-28；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
