ChiCTR2100052955 版本V1.6 版本创建时间2022/08/29 21:07:44 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100052955 

最近更新日期：

Date of Last Refreshed on：

 2022-08-29 21:06:22 

注册时间：

Date of Registration：

 2021-11-06 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评价重组新型冠状病毒疫苗（CHO细胞）接种于3至17周岁与18至59周岁人群的免疫原性比较临床试验

Public title：

A clinical trial comparing the immunogenicity of recombinant New Coronavirus vaccine (CHO cells) among people aged 3 to 17 and 18 to 59 years of age

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价重组新型冠状病毒疫苗（CHO细胞）接种于3至17周岁与18至59周岁人群的免疫原性比较临床试验

Scientific title：

A clinical trial comparing the immunogenicity of recombinant New Coronavirus vaccine (CHO cells) among people aged 3 to 17 and 18 to 59 years of age.

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：

钟再新 

研究负责人：

李放军 

Applicant：

Zhong Zaixin 

Study leader：

Li Fangjun 

申请注册联系人电话：

Applicant telephone：

 +86 18130032795

研究负责人电话：

Study leader's
telephone：

+86 13574109585

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：

 zhongzaixin@zhifeishengwu.com

研究负责人电子邮件：

Study leader's E-mail：

 646022285@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：

安徽省合肥市蜀山区科学大道93号

研究负责人通讯地址：

湖南长沙市芙蓉中路一段450号

Applicant address：

93 Science Avenue, Shushan District, Hefei, Anhui, China

Study leader's address：

450 First Section, Middle Furong Road, Changsha, Hunan, China

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：

安徽智飞龙科马生物制药有限公司

Applicant's institution：

Anhui Zhifeilongcome Biopharmaceutical Co., Ltd.

研究负责人所在单位：

湖南省疾病预防控制中心

Affiliation of the Leader：

Hunan Provincial Center for Disease Control and Prevention

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：

 湘疾控IRB-YJ2021046

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：

湖南省疾病预防控制中心伦理委员会

Name of the ethic committee：

Ethics Committee of Hunan Provincial Center for Disease Control and Prevention

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-11-02 00:00:00

伦理委员会联系人：

张博夫

Contact Name of the ethic committee：

Zhang Bofu

伦理委员会联系地址：

湖南长沙市芙蓉中路一段450号

Contact Address of the ethic committee：

45450 First Section, Middle Furong Road, Changsha, Hunan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

湖南省疾病预防控制中心

Primary sponsor：

Hunan Provincial Center for Disease Control and Prevention

研究实施负责（组长）单位地址：

湖南长沙市芙蓉中路一段450号

Primary sponsor's address：

450 First Section, Middle Furong Road, Changsha, Hunan, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

安徽

市(区县)：

合肥

Country：

China

Province：

Anhui

City：

Hefei

单位(医院)：

安徽智飞龙科马生物制药有限公司

具体地址：

蜀山区科学大道93号

Institution
hospital：

Anhui Zhifeilongcome Biopharmaceutical Co., Ltd.

Address：

93 Science Avenue, Shushan District

经费或物资来源：

单位自筹

Source(s) of funding：

Self-funded

研究疾病：

新型冠状病毒肺炎(COVID-19)  

Target disease：

Novel Coronavirus Pneumonia (COVID-19)

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 II期临床试验 

Study phase：

2

研究设计：

单臂 

Study design：

Single arm 

研究目的：

1.主要目的：证明试验疫苗接种于3~17周岁人群全程免疫后第14天的新型冠状病毒SARS-CoV-2中和抗体几何平均滴度（GMT）水平非劣效于18~59周岁人群（非劣效界值2/3）； 2.次要目的：评价试验疫苗接种于3~17周岁人群的安全性。评价试验疫苗接种于3~17周岁人群的免疫持久性。  

Objectives of Study：

1. Main purpose: To prove that the geometric mean titer (GMT) level of neutralizing antibody against SARS-CoV-2 in people aged 3-17 years old is non-inferior to those aged 18-59 years old (non-inferiority margin 2/3); 2. Secondary objective: To evaluate the safety of the experimental vaccine inoculated in people aged 3-17 years. To evaluate the immune persistence of experimental vaccines in 3-17 year olds.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄满3~17周岁（均包含）；
2.受试者自愿同意参加研究，和/或受试者的监护人自愿同意孩子参加研究，受试者本人（8-17周岁）和监护人签署知情同意书，且能提供有效身份证明，理解和遵守试验方案要求；
3.受试者和/或受试者的监护人有能力了解（非文盲）研究程序，承诺按照研究要求参加定期随访；
4.过去14天内无疫情高、中风险区、境外旅行史或居住史；且过去14天内无新型冠状病毒感染确诊病例、无症状感染者或疑似病例密切接触史；且过去14天内无来自疫情高、中风险区发热或有呼吸道症状患者接触史；且处于非隔离期内人员；
5.具有生育能力的男性和育龄女性受试者同意在研究开始至全程接种后2个月内采取有效避孕措施。

Inclusion criteria

1. At least 3 ~ 17 years old (both included);
2. The subject voluntarily agrees to participate in the study, and / or the guardian of the subject voluntarily agrees to the child to participate in the study. The subject himself (8-17 years old) and the guardian sign the informed consent form, and can provide valid identity certificates to understand and comply with the requirements of the test protocol;
3. The subject and / or the guardian of the subject have the ability to understand (non illiterate) the research procedures and promise to participate in regular follow-up according to the research requirements;
4. There is no high or medium risk area, overseas travel history or residence history in the past 14 days; In the past 14 days, no confirmed case of New Coronavirus infection, asymptomatic infection or suspected cases had been found. And there was no contact history of patients with fever or respiratory symptoms from high and medium risk areas in the past 14 days; Personnel in non isolation period;
5. Male and female subjects with fertility agreed to take effective contraceptive measures from the beginning of the study to 2 months after the whole vaccination.

排除标准：

1.筛选期体格检查结果异常且经临床医生判定有临床意义（不适宜接种疫苗）；
2.入组前72小时内（包括入组当天）怀疑或确诊发热者（＞14周岁，腋下体温≥37.3℃；≤14周岁，腋下体温≥37.5℃）；
3.对试验疫苗的任何成分，包括铝制剂有严重过敏史，例如：过敏性休克、过敏性喉头水肿、过敏性紫癜、血小板减少性紫癜、呼吸困难、血管神经性水肿等；或既往有任何疫苗或药物使用后出现上述严重副反应史；
4.既往有SARS和SARS-CoV-2病史者；
5.首剂疫苗接种前24小时内曾服用退热药或止痛药；
6.已接种新型冠状病毒疫苗者，或在首剂疫苗接种前7天以内接种亚单位疫苗和/或灭活疫苗等，或在14天以内接种减毒活疫苗；
7.在试验用疫苗接种前3个月内曾经接受过血液或血液相关制品，包括免疫球蛋白；或在研究期间有计划使用；
8.患有以下疾病者：在过去7天内患消化系统疾病（如，腹泻、腹痛、呕吐等）；患有先天畸形或发育障碍、遗传缺陷，严重营养不良等；先天性或获得性的免疫缺陷或自身免疫疾病史或在6个月内接受免疫调节剂治疗，如免疫抑制剂量的糖皮质激素（剂量参考：相当于强的松20mg/天，超过一周）；或单克隆抗体；或胸腺肽；或干扰素等；但允许局部用药（如软膏、滴眼液、吸入剂或鼻喷剂）；已知被诊断为现患有传染性疾病，例如：活动性结核、病毒性肝炎现患者、人类免疫性缺陷病毒感染者或梅毒螺旋体感染者；神经性疾病或神经发育不良（例如，惊厥，偏头痛，癫痫，中风，最近三年的癫痫发作，脑病，局灶性神经功能缺损，格林-巴利综合征，脑脊髓炎或横贯性脊髓炎）；精神病病史或家族史；功能性无脾，以及任何原因导致的无脾或脾切除；有严重慢性疾病或病情处于进展期不能平稳控制，如糖尿病、药物无法控制的高血压病；严重肝、肾疾病；当前需要日常药物治疗的呼吸道疾病（例如，慢性阻塞性肺疾病[COPD]，哮喘）或最近5年内对呼吸道疾病加重（例如，哮喘加重）的任何治疗；患有严重的心血管疾病（例如充血性心力衰竭，心肌病，缺血性心脏病，心律失常、传导阻滞、心肌梗塞、肺心病）或心肌炎或心包炎的病史；有血小板减少症、任何凝血功能障碍或接受抗凝血剂治疗等；癌症患者（基底细胞癌除外）；
9.哺乳期妇女或怀孕期妇女（包括育龄期女性尿妊娠试验阳性者）；
10.曾参与或正在参与其他临床试验相关访视尚未结束，或结束后明确为新冠疫苗接种者；
11.研究者认为，受试者存在任何疾病或状况可能会使受试者处于无法接受的风险；受试者无法满足方案要求；干扰对疫苗反应的评估的情况。

Exclusion criteria：

1. The results of the physical examination during the screening period are abnormal and have clinical significance as determined by the clinician (not suitable for vaccination);
2. Suspected or confirmed fever within 72 hours before enrollment (including the day of enrollment) (>14 years old, axillary body temperature >=37.3 degree; <=14 years old, axillary body temperature >=37.5 degree);
3. Have a history of severe allergy to any component of the test vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angioedema, etc.; or any previous history of History of the above-mentioned serious side effects after the use of vaccines or drugs;
4. Those with a history of SARS and SARS-CoV-2;
5. Antipyretics or pain relievers have been taken within 24 hours before the first dose of vaccination;
6. Those who have been vaccinated against the new coronavirus, or vaccinated with subunit vaccine and/or inactivated vaccine within 7 days before the first dose of vaccine, or vaccinated with live attenuated vaccine within 14 days;
7. Received blood or blood-related products, including immune globulin, within 3 months before the experimental vaccine; or planned to use it during the study;
8. Those suffering from the following diseases: suffering from digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days; suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; congenital or acquired immunity History of deficiency or autoimmune disease or treatment with immunomodulatory agents within 6 months, such as immunosuppressive doses of glucocorticoids (dose reference: equivalent to prednisone 20mg/day for more than one week); or monoclonal antibodies; or thymosin ; or interferon, etc.; but topical medication (such as ointment, eye drops, inhalation, or nasal spray) is allowed; known to be diagnosed with an existing infectious disease, such as: active tuberculosis, viral hepatitis, Human immunodeficiency virus infection or Treponema pallidum infection; neurological disease or neurodevelopmental dysplasia (eg, convulsions, migraine, epilepsy, stroke, seizures within the last three years, encephalopathy, focal neurological deficit, Guillain- Barre syndrome, encephalomyelitis, or transverse myelitis); psychiatric or family history; functional asplenia, and any cause of asplenia or splenectomy; severe chronic disease or disease that is progressive and uncontrolled, Such as diabetes, hypertension uncontrolled by medication; severe liver and kidney disease; current respiratory disease requiring daily medication (eg, chronic obstructive pulmonary disease [COPD], asthma) or worsening of respiratory disease within the past 5 years (eg, asthma exacerbations); history of severe cardiovascular disease (eg, congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, cor pulmonale) or myocarditis or pericarditis ; Patients with thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy, etc.; Cancer patients (except basal cell carcinoma);
9. Lactating women or pregnant women (including women of childbearing age with positive urine pregnancy test);
10. Those who have participated in or are participating in other clinical trials related visits have not ended, or are clearly vaccinated against the new crown after the end;
11. The investigator believes that the subject has any disease or condition that may put the subject at an unacceptable risk; the subject cannot meet the requirements of the protocol; circumstances that interfere with the assessment of vaccine response.

研究实施时间：

Study execute time：

从 From 2021-11-04 00:00:00至 To 2023-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-11-05 00:00:00 至 To 2022-12-31 00:00:00

干预措施：

Interventions：

组别：

未成年人组

样本量：

 400

Group：

Minor group

Sample size：

干预措施：

接种试验疫苗

干预措施代码：

Intervention：

Experimental vaccination

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

 湘潭 

Country：

China

Province：

Hu'nan

City：

Xiangtan

单位(医院)：

 湘潭县疾病预防控制中心 

单位级别：

  

Institution
hospital：

Xiangtan Center for Disease Control and Prevention

Level of the institution：

测量指标：

Outcomes：

指标中文名：

SARS-CoV-2中和抗体

指标类型：

主要指标

Outcome：

SARS-CoV-2 neutralizing antibody

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

RBD蛋白结合抗体（IgG）检测

指标类型：

主要指标

Outcome：

RBD protein binding antibody (IgG) detection

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：

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：

标本中文名：

尿

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：

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 3 岁 years
最大 Max age 17 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）：

随机化和盲法在本研究中不适用。采用非劣效性试验设计，评估试验疫苗接种于3~17周岁人群后的免疫原性非劣效于18~59周岁人群，借助我司重组新型冠状病毒疫苗（CHO细胞）的Ⅲ期临床试验国内18-59周岁人群的免疫原性结果进行非劣效假设检验。

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

Non inferiority test design was used to evaluate the immunogenicity of the vaccine inoculated to the age group of 3~17 and the age of 18~59. The non inferiority hypothesis test was conducted with the results of immunogenicity of the 18-59 year old group in the phase III clinical trial in China.

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：

N/A

Blinding：

N/A

是否共享原始数据：

IPD sharing

是Yes

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）：

中国知网 请阅读网页注册指南中关于 原始数据共享 的内容。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

https://www.cnki.net/

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：

CRF和EDC系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form and Electronic Data Capture System

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-11-06 21:34:29