中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2300077646
最近更新日期： Date of Last Refreshed on：	2024-06-11 16:53:47
注册时间： Date of Registration：	2023-11-15 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	评价水痘减毒活疫苗接种不同年龄健康人群安全性的随机、盲法、阳性对照的Ⅰ期临床试验
Public title：	A randomized, blinded, positively controlled phase I clinical trial evaluating the safety of live attenuated varicella vaccine in a healthy population of different ages
注册题目简写：
English Acronym：
研究课题的正式科学名称：	评价水痘减毒活疫苗接种不同年龄健康人群安全性的随机、盲法、阳性对照的Ⅰ期临床试验
Scientific title：	A randomized, blinded, positively controlled phase I clinical trial evaluating the safety of live attenuated varicella vaccine in a healthy population of different ages
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	刘苗苗	研究负责人：	杨北方
Applicant：	Liu Miaomiao	Study leader：	Yang Beifang
申请注册联系人电话： Applicant telephone：	+86 135 1609 0021	研究负责人电话： Study leader's telephone：	+86 27 8765 2281
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	13516090021@163.com	研究负责人电子邮件： Study leader's E-mail：	308041407@qq.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	辽宁省沈阳市浑南新区新放街1号	研究负责人通讯地址：	湖北省武汉市洪山区卓刀泉北路35号
Applicant address：	1 Xinfang Street, Hunnan New District, Shenyang, Liaoning, China	Study leader's address：	35 Zhuodaoquan Road North, Hongshan District, Wuhan, Hubei
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	辽宁成大生物股份有限公司
Applicant's institution：	Liaoning Chengda Biological Co.Ltd
研究负责人所在单位：	湖北省疾病预防控制中心
Affiliation of the Leader：	Disease Control Center, Hubei

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	2023-016-02	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	湖北省疾病预防控制中心（湖北省预防医学科学院）伦理委员会
Name of the ethic committee：	Ethics Committee of Disease Control Center, Hubei (Hubei Academy of Preventive Medicine)
伦理委员会批准日期： Date of approved by ethic committee：	2023-11-08 00:00:00
伦理委员会联系人：	曹新建
Contact Name of the ethic committee：	Cao Xinjian
伦理委员会联系地址：	湖北省武汉市洪山区卓刀泉北路35号
Contact Address of the ethic committee：	35 Zhuodaoquan Road North, Hongshan District, Wuhan, Hubei
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 27 8765 5285	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

湖北省疾病预防控制中心

Primary sponsor：

Disease Control Center, Hubei

研究实施负责（组长）单位地址：

湖北省武汉市洪山区卓刀泉北路35号

Primary sponsor's address：

35 Zhuodaoquan Road North, Hongshan District, Wuhan, Hubei

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	辽宁	市(区县)：
Country：	China	Province：	Liaoning	City：
单位(医院)：	辽宁成大生物股份有限公司	具体地址：	辽宁省沈阳市浑南新区新放街1号
Institution hospital：	Liaoning Chengda Biological Co.Ltd	Address：	1 Xinfang Street, Hunnan New District, Shenyang, Liaoning, China

国家：	中国	省(直辖市)：	辽宁	市(区县)：
Country：	China	Province：	Liaoning	City：
单位(医院)：	成大生物（本溪）有限公司	具体地址：	辽宁省本溪市高新技术产业开发区仙榆路6号
Institution hospital：	Chengda Biology (Benxi) Co., Ltd	Address：	6 Xianyu Road, High-Tech Industrial Development Zone, Benxi, Liaoning

经费或物资来源：

申办者自筹

Source(s) of funding：

self-raised by the sponsor

研究疾病：

预防水痘疾病

Target disease：

preventing varicella

研究疾病代码：

Target disease code：

研究类型：

预防性研究

Study type：

Prevention

研究所处阶段：

I期临床试验

Study phase：

1

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

评价1周岁及以上健康人群接种水痘减毒活疫苗的安全性。

Objectives of Study：

To evaluate the safety of live attenuated varicella vaccine in healthy people aged 1 year and older.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

通用排除标准： 1.接种疫苗前腋下体温≥37.3℃； 2.接种过水痘疫苗或麻疹-风疹-腮腺炎-水痘减毒活疫苗或有水痘疫苗或带状疱疹疫苗成分的已上市或研究类产品，有水痘病史或带状疱疹发病史，或近半个月内与水痘病人有密切接触史； 3.有疫苗/药物严重过敏史或严重的副反应史，如荨麻疹、呼吸困难、血管神经性水肿或腹痛等，或已知对试验用疫苗所含任一成分过敏者（包括新霉素，辅料，如：蔗糖、谷氨酸钠、氯化钠、氯化钾、磷酸氢二钠、磷酸二氢钾、海藻糖、人血白蛋白、葡萄糖、尿素、精氨酸、甘露醇）； 4.现患或曾患惊厥、癫痫、脑病（如先天性脑发育不全、脑外伤、脑肿瘤、脑出血、脑梗死、脑部感染、化学药物中毒等引起的大脑神经组织损伤等）、精神病或其他神经系统性疾病，或有精神病家族史； 5.患有先天性或获得性免疫缺陷或密切接触的家庭成员中有先天性免疫疾病史者，如幼儿母亲或本人有HIV感染、系统性红斑狼疮（SLE）、格林巴利综合症等，或其他自身免疫疾病； 6.原发或继发免疫功能受损者（甲状腺、胰脏、肝脏、脾脏切除史）； 7.免疫缺陷、免疫功能低下、6个月内接受免疫抑制治疗（如淋巴细胞总计数少于1200/mm3或表现为细胞免疫功能缺陷）、细胞毒性治疗、类固醇治疗（不包括过敏性鼻炎的皮质类固醇喷雾治疗，急性非并发皮炎的表面皮质类固醇治疗，强的松的用量为< 20 mg/天或使用其他等量药物）或共同居住者中有≤28天的婴儿、孕妇； 8.先天畸形、遗传缺陷、发育障碍、严重营养不良等； 9.已知或怀疑患有严重的疾病（急性或慢性），如有并发症的糖尿病、各种感染性、化脓性及过敏性等皮肤病、Down氏综合症、镰刀细胞贫血、心脑血管疾病（冠心病、肺心病、肺水肿、18岁及以上的成人经药物不能控制的高血压（收缩压≥140mmHg和/或舒张压≥90mmHg）、肝肾疾病、呼吸系统疾病（包括肺炎、肺结核、严重哮喘、慢性支气管炎发作期等）、恶性肿瘤等； 10.近7天内各种急性疾病、慢性疾病急性发作、传染病或使用了退热、镇痛、抗过敏药物； 11.存在肌肉注射禁忌症，例如：经过医生诊断的凝血功能异常（如凝血因子缺乏，血小板减少症，凝血性疾病等明显青肿或凝血障碍或接受抗凝血剂治疗等）； 12.入组前5个月曾经接受过血液或血液相关制品（如免疫球蛋白）治疗； 13.接种试验用疫苗前1个月内接受过减毒活疫苗或14天内接受过亚单位或灭活疫苗； 14.首次接种前3个月内使用过其他研究性或未注册的产品（药品或疫苗），或本次临床试验入组后有计划参加其他临床试验； 15.目前正在使用水杨酸盐类药物（主要为水杨酸、阿司匹林、二氟尼柳、对氨基水杨酸（钠）、双水杨酯和贝诺酯），或计划在研究期间长期使用； 16.正在接受抗病毒治疗或服用抗病毒药物； 17.有长期酗酒或药物滥用史； 18.免前实验室检查指标存在异常，且经临床医生判定为异常有临床意义者； 19.每剂疫苗接种后6周内无法避免与水痘易感的高危人群（如婴儿、免疫抑制人群、无既往疫苗接种史或感染史的孕妇、妊娠期头3个月的妊娠妇女等）接触者； 20.计划在临床试验结束前搬离本地或在预定研究访视期间长时间离开本地； 21.根据研究者判断，受试者有任何其他不适合参加临床试验的因素。非通用排除标准： 1.孕妇、哺乳期妇女或计划在试验期间怀孕妇女； 2.1~2周岁幼儿：出生时体重＜2.5kg；异常产程出生（难产）或有窒息、神经器官损害史；有诊断确定的病理性黄疸（持续2~4周，重复出现）；早产儿。

Exclusion criteria：

General Exclusion Criteria: 1. Axillary temperature >= 37.3°C prior to vaccination; 2. Those who has received varicella vaccine or live attenuated measles-rubella-mumps-varicella vaccine or marketed/investigated products with varicella/zoster vaccine components, have an onset history of varicella or herpes zoster, or have had a close-contact history with varicella patients within the past half month; 3. Those who has a history of severe allergy or serious adverse reaction to any vaccine/drug, such as urticaria, dyspnea, angioneurotic edema, or abdominal pain, or are known to be allergic to any of the ingredients of investigational vaccines (including neomycin, excipients, such as: Sucrose, sodium glutamate, sodium chloride, potassium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, trehalose, human blood albumin, glucose, urea, arginine, mannitol); 4. Medical diagnosis or history of convulsions, epilepsy, encephalopathy (e.g. congenital cerebral insufficiency, traumatic brain injury, brain tumor, cerebral hemorrhage, cerebral infarction, cerebral infections, brain's neural tissues injury caused by chemical poisoning, etc.), psychosis, or other neurological disorders, or has a family history of psychosis; 5. Those who was diagnosed with congenital or acquired immunodeficiencies or whose close contact family members were diagnosed with congenital immune diseases in close family members, such as HIV infection in the mother of a young child or in the child himself/herself, systemic lupus erythematosus (SLE), Guillain-Barré Syndrome, etc., or other autoimmune diseases; 6. Essential or secondary immunocompromised patients (thyroid, pancreas, liver, spleen excision history); 7. Those who diagnosed with immune deficiency or immunocompromised. Those who accepted immunosuppressive therapy (e.g. total lymphocyte counts less than 1200/mm3 or cellular immune deficiency), cytotoxic therapy, steroid therapy within 6 months (except: corticosteroid spray therapy for allergic rhinitis, surface corticosteroid therapy for acute non-concurrent dermatitis, Prednisone dosage < 20 mg/day or other equivalent drug). Whose co-occupants are infants aged <= 28 days or pregnant women; 8. Congenital malformations, genetic defects, developmental disorders, severe malnutrition, etc.; 9. Those who have diagnosed or suspected with serious illness (acute or chronic), such as diabetes mellitus with complications, various infectious, suppurative and allergic skin diseases, Down syndrome, sickle cell anemia, cardio-cerebrovascular diseases (coronary heart disease, pulmonary heart disease, pulmonary edema, medically uncontrollable hypertension [systolic blood pressure >= 140mmHg and/or diastolic blood pressure >= 90mmHg as reference for adults aged 18 years and older]), liver and kidney diseases, respiratory diseases (including pneumonia, tuberculosis, severe asthma, onset phase of chronic bronchitis, etc.), malignant tumors, etc.; 10. All kinds of acute illnesses, acute attacks of chronic diseases, infectious diseases, or the use of antipyretic, analgesic, or antiallergic drugs within the last 7 days; 11. Contraindications to intramuscular injection, e.g., physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, thrombocytopenia, significant bruising caused by coagulation disorders, coagulation disorders or anticoagulants treatment); 12. Received blood or blood-related products (such as immunoglobulin) in the 5 months prior to enrollment; 13. Received live attenuated vaccine within 1 month or subunit/inactivated vaccine within 14 days prior to receiving the investigated vaccine; 14. Use of any other investigational or unlicensed product (drug or vaccine) within 3 months prior to initial vaccination, or plan to participate in other clinical trials after enrollment of this clinical trial; 15. Salicylate drugs (mainly salicylic acid, aspirin, diflunix, p-aminosalicylic acid [sodium], dissalicylate and benoxate) are currently being used or are planned for long-term use during the study period; 16. Under antiviral treatment or taking antiviral drugs; 17. History of long-term alcohol or drug abuse; 18. Those who had abnormal laboratory examination indicators before vaccination and were judged as clinically significant by clinicians; 19. Those who are unable to avoid contact with varicella-susceptible high-risk groups (e.g., infants, immunosuppressed persons, pregnant women with no previous history of vaccination or infection, pregnant women in the first trimester of pregnancy, etc.) for 6 weeks after each dose of vaccination; 20. Plan to move away from the local area before the end of the clinical trial or leave for a long time during the scheduled study visit; 21. In the investigator's judgment, subjects have any other factors that make them ineligible to participate in the clinical trial; Non-generic exclusion criteria: 1. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial; 2. 1-2 years old: birth weight < 2.5kg; birth in abnormal labor (obstructed labor) or history of asphyxia or neurological organ injury; diagnosed pathological jaundice (lasting 2-4 weeks, recurring); preterm infants.

研究实施时间：

Study execute time：

从 From 2023-11-15 00:00:00至 To 2025-08-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-11-15 00:00:00 至 To 2024-01-13 00:00:00

干预措施：

Interventions：

组别：	A1	样本量：	24
Group：	A1	Sample size：	24
干预措施：	18-59周岁受试者按照0、42天接种试验疫苗	干预措施代码：
Intervention：	The subjects aged from 18 to 59 years were vaccinated according to 0 and 42 days immunization program	Intervention code：

组别：	A2	样本量：	24
Group：	A2	Sample size：	24
干预措施：	18-59周岁受试者按照0、42天接种对照疫苗2	干预措施代码：
Intervention：	The subjects aged from 18 to 59 years were vaccinated with control vaccine 2 according to 0 and 42 days immunization program	Intervention code：

组别：	B1	样本量：	24
Group：	B1	Sample size：	24
干预措施：	13-17周岁受试者按照0、42天接种试验疫苗	干预措施代码：
Intervention：	The subjects aged from 13 to 17 years were vaccinated according to 0 and 42 days immunization program	Intervention code：

组别：	B2	样本量：	24
Group：	B2	Sample size：	24
干预措施：	13-17周岁受试者按照0、42天接种对照疫苗2	干预措施代码：
Intervention：	The subjects aged from 13 to 17 years were vaccinated with control vaccine 2 according to 0 and 42 days immunization program	Intervention code：

组别：	C1	样本量：	24
Group：	C1	Sample size：	24
干预措施：	60周岁及以上受试者按照0、42天接种试验疫苗	干预措施代码：
Intervention：	The subjects aged 60 years and over were vaccinated according to 0 and 42 days immunization program	Intervention code：

组别：	C2	样本量：	24
Group：	C2	Sample size：	24
干预措施：	60周岁及以上受试者按照0、42天接种对照疫苗2	干预措施代码：
Intervention：	The subjects aged from 60 years and over were vaccinated with control vaccine 2 according to 0 and 42 days immunization program	Intervention code：

组别：	D1	样本量：	24
Group：	D1	Sample size：	24
干预措施：	4-12周岁受试者按照0、3月接种试验疫苗	干预措施代码：
Intervention：	The subjects aged from 4 to 12 years were vaccinated according to 0 and 3 months immunization program	Intervention code：

组别：	D2	样本量：	24
Group：	D2	Sample size：	24
干预措施：	4-12周岁受试者接种1剂对照疫苗1	干预措施代码：
Intervention：	Subjects aged 4-12 years received 1 dose of control vaccine1	Intervention code：

组别：	E1	样本量：	24
Group：	E1	Sample size：	24
干预措施：	1-3周岁受试者按照0、3月接种试验疫苗	干预措施代码：
Intervention：	The subjects aged from 1 to 3 years were vaccinated according to 0 and 3 months immunization program	Intervention code：

组别：	E2	样本量：	24
Group：	E2	Sample size：	24
干预措施：	1-3周岁受试者接种1剂对照疫苗1	干预措施代码：
Intervention：	Subjects aged 1-3 years received 1 dose of control vaccine1	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	湖北	市(区县)：
Country：	China	Province：	Hubei	City：
单位(医院)：	湖北省咸宁市通城县疾病预防控制中心	单位级别：	N/A
Institution hospital：	Disease Control Center, Yunyang District, Xianning, Tongcheng	Level of the institution：	N/A

测量指标：

Outcomes：

指标中文名：	不良事件	指标类型：	主要指标
Outcome：	Adverse event, AE	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	特别关注不良事件	指标类型：	主要指标
Outcome：	special attention to adverse events, AESI	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	排毒规律	指标类型：	次要指标
Outcome：	regularity of detoxification	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	严重不良事件	指标类型：	主要指标
Outcome：	Serious adverse event, SAE	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	尿液	组织：
Sample Name：	urine	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

标本中文名：	唾液	组织：
Sample Name：	saliva	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	Note：

标本中文名：	血液	组织：
Sample Name：	blood	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	1	岁 years
最大 Max age	N/A	岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由北京康特瑞科统计科技有限责任公司非盲随机化统计师采用区组随机化的方法产生随机序列。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The random sequence was generated by the unblinded randomized statistician of Beijing Conterec Statistical Technology Co., Ltd. by stratified block randomization.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

由与本试验无关的申办者或第三方人员根据随机化统计师产生的随机编码表打印疫苗标签，编盲工作由申办者协调组织并在随机化统计师现场监督条件下完成，以确保编盲过程合规、无误、记录完整。将打印好的疫苗标签粘贴于每份疫苗指定位置，疫苗编号同研究编号，外包装贴封口签，在疫苗配置前不得破坏。整个编盲过程须有文字记录。编盲人员不得参加项目临床试验工作，同时也不得向参加临床试验工作的任何人员泄露编盲内容。由于4~12周岁、1~3周岁受试者不同组间接种程序不同，无法完全保持盲态，为尽量减小相关人员获得分组信息的概率，现场采用独立带编号的随机分配卡，受试者于首剂免后42天回收联系卡时刮开随机分配卡获知免疫程序。此外，进行检测的实验室工作人员均为盲态。因设盲后的试验疫苗和对照疫苗1、对照疫苗2仅外包装相同，但内包装不同，为维持研究过程中的盲态，采取相关措施以维持盲态。

Blinding：

The vaccine label is printed by the sponsor or a third-party person unrelated to this trial according to the randomization coding table generated by the randomization statistician, and the blinding work is coordinated and organized by the sponsor and completed under the on-site supervision of the randomization statistician to ensure that the blinding process is compliant, error-free, and the record is complete. Paste the printed vaccine label at the designated position of each vaccine, the vaccine number is the same as the study number, and the outer packaging is labeled with a sealing label, which shall not be damaged before the vaccine is configured. The entire blinding process must be documented. Blind personnel shall not participate in the clinical trial work of the project, and shall not disclose the blinding content to any person participating in the clinical trial work. In order to minimize the probability of relevant personnel obtaining grouping information, an independent numbered randomization card was used on site, and the subjects scratched the randomization card when the contact card was collected 42 days after the first dose was immunized. In addition, the laboratory staff performing the tests are blinded. Since the blinded test vaccine and the control vaccine 1 and control vaccine 2 only have the same outer packaging, but the inner packaging is different, in order to maintain the blindness during the research process, relevant measures were taken to maintain the blinding state.

是否共享原始数据： IPD sharing	否No
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	N/A
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	N/A
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	“电子数据采集系统（EDC）”建立 eCRF。eCRF 用于记录临床试验的数据（包括受试者编号、知情同意书签署情况、人口学信息、入选/排除标准筛查信息、疫苗接种记录、随访日期、不良事件及其处理和转归、合并用药和合并用疫苗等），是临床试验和研究报告的重要组成部分，要求按照 EDC 系统使用说明书及 eCRF 填写说明要求，使用规范用语录入。 eCRF上的所有数据均来源于原始资料，并和原始资料一致。任何 eCRF 数据的录入、核查、修改、清理及质控等过程将在 EDC 系统中记录。完成数据清理后，研究者应对每一份 eCRF 中数据进行确认并做电子签名。在试验期间只允许研究者和经批准的工作人员访问 EDC 系统。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The Electronic Data Collection System (EDC) establishes eCRF. ECRF is used to record clinical trial data (including subject number, informed consent form signing status, demographic information, screening information for inclusion/exclusion criteria, vaccination records, follow-up dates, adverse events and their management and outcomes, co medication and co vaccine use, etc.), and is an important component of clinical trials and research reports. It is required to follow the EDC system user manual and eCRF filling instructions, Use standardized language input. All data on eCRF is sourced from and consistent with the original data. The entry, verification, modification, cleaning, and quality control processes of any eCRF data will be recorded in the EDC system. After completing data cleaning, researchers should confirm and electronically sign the data in each eCRF. During the experiment, only researchers and approved staff were allowed to access the EDC system.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2023-11-15 10:03:17