ChiCTR2200058396 版本V1.1 版本创建时间2022/12/12 13:01:47 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：

 ChiCTR2200058396 

最近更新日期：

Date of Last Refreshed on：

 2022-04-12 18:40:10 

注册时间：

Date of Registration：

 2022-04-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评价6～23月龄健康婴幼儿接种ACYW135群脑膜炎球菌多糖结合疫苗的免疫原性和安全性的III期临床试验

Public title：

A phase III clinical study to evaluate the immunogenicity and safety of Groups ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy subjects aged 6 to 23 months

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价6～23月龄健康婴幼儿接种ACYW135群脑膜炎球菌多糖结合疫苗的免疫原性和安全性的III期临床试验

Scientific title：

A phase III clinical study to evaluate the immunogenicity and safety of Groups ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy subjects aged 6 to 23 months

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：

杨舒媛 

研究负责人：

黄涛 

Applicant：

Yang Shuyuan 

Study leader：

Huang Tao 

申请注册联系人电话：

Applicant telephone：

 18687832269

研究负责人电话：

Study leader's
telephone：

15084736658

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：

 ynwsysy@walvax.com

研究负责人电子邮件：

Study leader's E-mail：

 ymlc01@hncdc.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：

云南省昆明市高新区云南省大学科技园

研究负责人通讯地址：

湖南省长沙市芙蓉中路一段450号

Applicant address：

Yunnan University Science and Technology Park, High-tech Zone, Kunming,Yunnan

Study leader's address：

No. 450, Section 1, Furong Middle Road, Changsha, Hunan

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：

云南沃森生物技术股份有限公司

Applicant's institution：

Walvax Biotechnology Co., Ltd.

研究负责人所在单位：

Affiliation of the Leader：

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-PJ2022005

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：

 2022-01-28 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：

长沙市芙蓉中路一段450号

Contact Address of the ethic committee：

No. 450, Section 1, Furong Middle Road, Changsha

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：

Disease control and prevention center of Hunan Provincial

研究实施负责（组长）单位地址：

湖南省长沙市芙蓉中路一段450号

Primary sponsor's address：

No. 450, Section 1, Furong Middle Road, Changsha, Hunan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南

市(区县)：

长沙

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

湖南省疾病预防控制中心

具体地址：

湖南省长沙市芙蓉中路一段450号

Institution
hospital：

Disease control and prevention center of Hunan Provincial

Address：

450, Section 1, Furong Middle Road, Changsha, Hu'nan

经费或物资来源：

申办者自筹

Source(s) of funding：

Self-funded

研究疾病：

预防A群、C群、Y群和W135群脑膜炎球菌引起的流行性脑脊髓膜炎  

Target disease：

This vaccine is indicated for active immunization to prevent invasive meningococcal diseases caused by N. meningitidis serogroups A, C, Y and W135

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：

 III期临床试验 

Study phase：

3

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的：评价6～23月龄健康婴幼儿按照2剂免疫程序接种ACYW135结合疫苗后的免疫原性和安全性。 次要目的：评价6～11月龄健康婴幼儿在完成ACYW135结合疫苗2剂免疫后，于18月龄加强免疫1剂的免疫原性和安全性。  

Objectives of Study：

Primary objective: To evaluate the immunogenicity and safety of the investigational vaccine in a two-dose regimen in healthy subjects aged 6-23 months Secondary objective: To evaluate the immunogenicity and safety of 1 booster dose of group ACYW135 meningococcal polysaccharide conjugate vaccine administered at the age of 18 months in healthy infants aged 6-11 months after the completion of the 2-dose regimen of group ACYW135 meningococcal polysaccharide conjugate vaccine as primary series.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

志愿者须符合所有下列入选标准：1.符合本次临床试验入组年龄（6～11月龄或12～23月龄）的健康婴幼儿。2.志愿者的法定监护人自愿同意其孩子参加本次研究，签署知情同意书（如法定监护人外出可在书面委托的前提下由法定监护人的被委托人代为签署）。3.志愿者及其法定监护人/被委托人具有按照临床试验方案参加本试验的能力。4.6~11月龄志愿者应未接种过任何脑膜炎球菌类疫苗（包括但不限于：A群多糖疫苗、AC结合疫苗）。5.12~23月龄志愿者未接种过任何脑膜炎球菌类疫苗（包括但不限于：A群多糖疫苗、AC结合疫苗）；或只接种过A群脑膜炎球菌多糖疫苗，且与上一剂接种间隔>3个月。

Inclusion criteria

Volunteers must meet all of the following inclusion criteria: 1. Healthy infants in accordance with the age of this clinical trial (6-11 months old or 12-23 months old ). 2. The legal guardian of the volunteer voluntarily agreed that the child would participate in the study and signed the informed consent. 3. Volunteers and their legal guardians have the ability to participate in the trial according to the clinical trial protocol. 4. Volunteers aged 6-11 months should not have received any meningococcal vaccine (including but not limited to: Group A Meningococcal Polysaccharide Vaccine and Group A and C Meningococcal conjugate vaccine). 5. Volunteers aged 12-23 months should not have received any meningococcal vaccine (including but not limited to: Group A Meningococcal Polysaccharide Vaccine and Group A and C Meningococcal conjugate vaccine).Or the Volunteers aged 12-23 months should only have received Group A Meningococcal Polysaccharide Vaccine.The interval between the day of vaccination a Group A Meningococcal Polysaccharide Vaccine should be at least 3 months.

排除标准：

首剂排除标准：志愿者有以下任一情况的则不能纳入研究：1.孕周<37周的早产儿，或孕周>42周的婴儿，或出生体重<2500g的低体重儿，或出生体重＞4000g的巨大儿；或先天畸形、发育障碍、遗传缺陷，严重营养不良等。2.志愿者异常产程出生（难产、器械助产）或有窒息抢救史、神经器官损害史，试管婴儿或多胎（三胞胎及以上胞胎）（仅适用于6-11月龄婴幼儿）。3.志愿者诊断确认患有病理性黄疸或曾患病理性黄疸（持续2～4周，且重复出现）（仅适用于6-11月龄婴幼儿）。4.已知志愿者对本临床试验用疫苗的某种成分（主要包括：A群脑膜炎球菌荚膜多糖、C群脑膜炎球菌荚膜多糖、Y群脑膜炎球菌荚膜多糖、W135群脑膜炎球菌荚膜多糖、白喉类毒素或白喉类抗原、破伤风类毒素或破伤风类抗原、乳糖、磷酸二氢钠、磷酸氢二钠）过敏或其直系亲属既往接种疫苗对上述成分过敏。5.志愿者既往有疫苗接种或药物严重过敏史。（例如但不限于：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、局部过敏坏死反应（Arthus反应））。6.志愿者有惊厥、癫痫、脑病和精神病史或上述疾病家族史。7.志愿者有明确诊断的血小板减少、任何凝血功能障碍或正在接受抗凝血剂治疗等肌肉注射禁忌症。8.志愿者已知或怀疑有免疫学功能异常（如：HIV感染，甲状腺、胰脏、肝脏、脾脏、肾脏病史或切除史），既往接受或正在接受免疫抑制剂治疗、细胞毒性治疗、入组前3个月内接受全身性糖皮质激素类药物治疗（任何用药途径，≥2mg/kg/天，≥7天）。9.志愿者现患脑膜炎或有脑膜炎患病史。10.已知志愿者患有先天畸形、发育障碍或有临床诊断的严重慢性病（如唐氏综合征、地中海贫血、镰刀细胞贫血或神经疾患、格林巴利综合症等）。11.已知或怀疑志愿者患有经研究者判定影响疫苗接种的疾病例如：严重的呼吸系统疾病、急性感染或慢性病活动期、严重心血管疾病、肝肾疾病、恶性肿瘤、严重的感染性或变态反应类皮肤病。12.志愿者3个月内（<3个月）接受过血液制品或免疫球蛋白（乙肝免疫球蛋白除外）。13.志愿者正在参加或者计划在本III期临床试验期间参加其他药物、医疗器械的临床试验。14.研究者认为志愿者存在有可能影响临床试验评估的任何情况。
后续剂次排除标准：如果受试者在安全性观察期间内中出现以下任一情况，则不可继续接种疫苗，但可以根据研究者判断继续其它研究步骤：1.前次疫苗接种后发生严重急性过敏反应者；2.发生与前次疫苗接种有因果关系的严重不良事件者；3.前次疫苗接种后新发现或新发生的符合首剂排除标准者；4.前次疫苗接种后接种过其他脑膜炎球菌类疫苗；5.研究者认为有可能影响评估的任何情况。
后续剂次推迟标准：如果受试者任一后续剂次接种前出现以下任一情况，则应推迟接种，待符合接种要求后再行接种：1.疫苗接种时腋下体温≥37.5℃；2.过去3天内腋下体温≥38.0℃；3.接种前3天内患急性疾病、慢性疾病的急性发作期；4.接种前3天内，服用过退热、镇痛和抗过敏药物（如：对乙酰氨基酚、布洛芬、阿司匹林等）；5.接受试验用疫苗当天与其他亚单位或灭活疫苗接种时间间隔不足7天，与其他减毒活疫苗接种时间间隔不足14天。6.研究者认为存在可能需要推迟接种的任何情况。

Exclusion criteria：

Exclusion criteria for the first dose of vaccination: Volunteers with any of the following conditions could not be included in the study: 1. Volunteers with gestational age less than 37 weeks or more than 42 weeks, birth weight less than 2.5 kg or more than 4.0 kg, or congenital malformations, developmental disorders, genetic defects, severe malnutrition, etc. 2. Volunteers who were born with abnormal labor processes (dystocia at birth, instrumental Midwifery) or a history of asphyxia and nervous and organ damage were test-tube infants or multiple births (triplets and above) (only applicable to infants aged 6-11 months). 3. The volunteers are suffering from or had been suffering from rational jaundice (lasting for 2-4 weeks and repeated) (only applicable to infants aged 6-11 months). 4. Known volunteers are allergic to certain ingredients of the vaccine used in this clinical trial (mainly including group A meningococcal capsular polysaccharide, group C meningococcal capsular polysaccharide, group Y meningococcal capsular polysaccharide, group W135 meningococcal capsular polysaccharide, diphtheria toxoid or diphtheria antigen, tetanus toxoid or tetanus antigen, lactose, sodium dihydrogen phosphate, disodium hydrogen phosphate), or their immediate family members had been vaccinated with meningococcal vaccine and were allergic to the above ingredients. 5. The volunteers or their immediate family members had a history of vaccine allergy or severe drug allergy (for example, but not limited to: anaphylactic shock, anaphylactic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction (Arthus reaction)). 6. The volunteers had a history of convulsion, epilepsy, encephalopathy and psychosis or a family history of the above diseases. 7. The volunteers had a history of thrombocytopenia or other coagulation disorders or were receiving anticoagulant therapy with contraindications to intramuscular injection. 8. It is known or suspected that the volunteers have immunological dysfunction (such as HIV infection, history of thyroid, pancreas, liver, spleen, kidney or resection), have received or are receiving immunosuppressive therapy, cytotoxic therapy, or received systemic glucocorticoid therapy within 3 months before enrollment (any route of administration, ≥2 mg/kg/day, ≥7 days). 9. The volunteers are suffering from meningitis or have a history of meningitis. 10. It is known that the volunteers have severe congenital malformations, developmental disorders or severe chronic diseases with clinical diagnosis (such as Down's syndrome, severe thalassemia, sickle cell anemia or neurological diseases, Guillain Barre syndrome, etc.). 11. It is known or suspected that the volunteers have diseases to affect the vaccination at the discretion of investigators, such as severe respiratory diseases, acute infection or chronic disease activity, severe cardiovascular diseases, liver and kidney diseases, malignant tumors, severe infectious or allergic skin diseases. 12. Volunteers received blood products or immunoglobulin after birth (except hepatitis B immunoglobulin). 13. Volunteers plan to participate in or are participating in other drug clinical trials. 14. Volunteers have any situation that may affect the evaluation of clinical trials at the discretion of investigators.
Exclusion criteria for follow-up dose vaccination: In case of any of the following situations during the safety observation period, the subject can not continue to receive the vaccine, but can continue other research steps at the discretion of the investigator: (1) Severe acute allergic reaction occurred after the previous dose of vaccination; (2) Serious adverse events related to the previous dose of vaccination occurred; (3) Those who met the first dose exclusion criteria were found or newly occurred after the previous dose of vaccination; (4) Those who received any meningococcal vaccine after the previous dose of vaccination. (5)Any situation that the researchers believe may affect the assessment.
Criteria for postponement of the subsequent doses: If any of the following conditions occur before any subsequent dose vaccination, the vaccination should be postponed until the vaccination requirements are met (1) Before vaccination, the axillary temperature was ≥37.5 degrees; (2) Axillary temperature was ≥37.3 degrees within recent 72 hours before vaccination;(3) Acute disease or an acute attack of chronic disease within 3 days before inoculation; (4) They had taken antipyretic and analgesic drugs or antiallergic drugs (eg., acetaminophen, ibuprofen, aspirin, etc)within 3 days before inoculation; (5) The interval between the investigational vaccine and other subunit or inactivated vaccine was less than 7 days, and the interval between the investigational vaccine and other live attenuated vaccine was less than 14 days. (6)Any other situation considered by the investigator as appropriate to postpone the subsequent doses of vaccination.

研究实施时间：

Study execute time：

从 From 2022-03-30 00:00:00至 To 2024-07-05 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-03-30 00:00:00 至 To 2022-04-05 00:00:00

干预措施：

Interventions：

组别：

6-11月龄试验组1

样本量：

 300

Group：

Study group 1(6-11 months)

Sample size：

干预措施：

第0、1月各接种1剂ACYW135结合疫苗；18月龄接种1剂ACYW135结合疫苗

干预措施代码：

Intervention：

The investigational vaccine is to be administered at Months 0 and 1 as the primary series and 18 months of age as the booster dose

Intervention code：

组别：

6-11月龄对照组

样本量：

 300

Group：

Control group(6-11 months)

Sample size：

干预措施：

第0、1月各接种1剂AC结合疫苗

干预措施代码：

Intervention：

The comparator vaccine Group A and C Meningococcal conjugate vaccineis to be administered at Months 0 and 1 .

Intervention code：

组别：

6-11月龄试验组2

样本量：

 300

Group：

Study group 2(6-11 months)

Sample size：

干预措施：

第0、3月各接种1剂ACYW135结合疫苗；18月龄接种1剂ACYW135结合疫苗

干预措施代码：

Intervention：

The investigational vaccine is to be administered at Months 0 and 3 as the primary series and 18 months of age as the booster dose

Intervention code：

组别：

12-23月龄试验组1

样本量：

 300

Group：

Study group 1 (12-23 months)

Sample size：

干预措施：

第0、1月各接种1剂ACYW135结合疫苗

干预措施代码：

Intervention：

The investigational vaccine is to be administered at Months 0 and 1 .

Intervention code：

组别：

12-23月龄对照组

样本量：

 300

Group：

Control group (12-23 months)

Sample size：

干预措施：

第0、1月各接种1剂AC结合疫苗

干预措施代码：

Intervention：

The comparator vaccine Group A and C Meningococcal conjugate vaccineis is to be administered at Months 0 and 1 .

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)：

 宁乡 

Country：

China

Province：

Hu'nan

City：

Ningxiang

单位(医院)：

 宁乡市疾病预防控制中心 

单位级别：

  

Institution
hospital：

Center for Disease Control and Prevention of Ningxiang

Level of the institution：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

 茶陵 

Country：

China

Province：

Hu'nan

City：

Chaning

单位(医院)：

 茶陵县疾病预防控制中心 

单位级别：

  

Institution
hospital：

Center for Disease Control and Prevention of Chaning County

Level of the institution：

国家：

 中国

省(直辖市)：

 贵州 

市(区县)：

 思南 

Country：

China

Province：

Guizhou

City：

Sinan

单位(医院)：

 思南县疾病预防控制中心 

单位级别：

  

Institution
hospital：

Center for Disease Control and Prevention of Sinan County

Level of the institution：

国家：

 中国

省(直辖市)：

 贵州 

市(区县)：

 松桃苗族自治县 

Country：

China

Province：

Guizhou

City：

Miao Autonomous County of Songtao

单位(医院)：

 松桃苗族自治县疾病预防控制中心 

单位级别：

  

Institution
hospital：

Center for Disease Control and Prevention of Miao Autonomous County of Songtao

Level of the institution：

测量指标：

Outcomes：

指标中文名：

A群脑膜炎球菌血清杀菌力（rSBA）抗体

指标类型：

主要指标

Outcome：

Group A meningococcal serum bactericidal activity (rsba) 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：

C群脑膜炎球菌血清杀菌力（rSBA）抗体

指标类型：

主要指标

Outcome：

Group C meningococcal serum bactericidal activity (rsba) 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：

Y群脑膜炎球菌血清杀菌力（rSBA）抗体

指标类型：

主要指标

Outcome：

Group Y meningococcal serum bactericidal activity (rsba) 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：

W135群脑膜炎球菌血清杀菌力（rSBA）抗体

指标类型：

主要指标

Outcome：

Group W135 meningococcal serum bactericidal activity (rsba) antibody

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：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 0.6 岁 years
最大 Max age 2.3 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）：

非盲随机化统计师应用SAS统计软件（9.4版本），采用区组随机化方法产生随机化盲底。

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

SAS statistical software (version 9.4) is used by an unblinded randomization statistician to generate a randomized blinding code using 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：

Blinding：

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）：

手动上传

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

upload manually

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：

使用电子数据采集（EDC）系统对用于统计分析的必要数据进行采集。

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

An Electronic Data Capture (EDC) system will be used to collect necessary data for statistical analysis

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2022-04-08 11:43:18