ChiCTR2500096692 版本V1.0 版本创建时间2025/02/05 08:42:40 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：

 ChiCTR2500096692 

最近更新日期：

Date of Last Refreshed on：

 2025-02-05 08:42:31 

注册时间：

Date of Registration：

 2025-02-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评价三价流感病毒裂解疫苗（MDCK细胞）在6月龄及以上人群中接种的安全性和初步免疫原性的随机、盲法、阳性对照Ⅰ期临床试验

Public title：

A Randomized, Blinded, Positively Controlled Phase I Clinical Trial to Evaluate the Safety and Initial Immunogenicity of Trivalent Influenza Vaccine (Split Virion),Inactivated (MDCK Cell) Vaccination in a Population 6 Months of Age and Older

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价三价流感病毒裂解疫苗（MDCK细胞）在6月龄及以上人群中接种的安全性和初步免疫原性的随机、盲法、阳性对照Ⅰ期临床试验

Scientific title：

A Randomized, Blinded, Positively Controlled Phase I Clinical Trial to Evaluate the Safety and Initial Immunogenicity of Trivalent Influenza Vaccine (Split Virion),Inactivated (MDCK Cell) Vaccination in a Population 6 Months of Age and Older

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：

李佳 

研究负责人：

刘晓强 

Applicant：

Li Jia 

Study leader：

Liu Xiaoqiang 

申请注册联系人电话：

Applicant telephone：

 +86 186 2821 6286

研究负责人电话：

Study leader's
telephone：

+86 159 1156 8282

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：

 li.jia@xenomix.cn

研究负责人电子邮件：

Study leader's E-mail：

 lxq7611@126.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：

成都天府国际生物城D3栋(双流区生物城中路二段18号)

研究负责人通讯地址：

云南省昆明市东寺街158号

Applicant address：

Building D3, Chengdu Tianfu International Bio-city (No. 18, Sec. 2, Bio-city Middle Road, Shuangliu District)

Study leader's address：

No. 158, Dongsi Street, Kunming, Yunnan Province, 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：

成都新诺明生物科技有限公司

Applicant's institution：

Chengdu XENOMIX Biotechnology Co.

研究负责人所在单位：

云南省疾病预防控制中心

Affiliation of the Leader：

Yunnan 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：

 批件2024-11号

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：

云南省疾病预防控制中心疫苗临床试验伦理委员会

Name of the ethic committee：

Yunnan Provincial Center for Disease Control and Prevention Vaccine Clinical Trial Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-12-18 00:00:00

伦理委员会联系人：

李发欣

Contact Name of the ethic committee：

Li Faxin

伦理委员会联系地址：

云南省昆明市东寺街158号

Contact Address of the ethic committee：

No. 158, Dongsi Street, Kunming, Yunnan Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 871 6362 6157

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：

云南省疾病预防控制中心

Primary sponsor：

Yunnan Center for Disease Control and Prevention

研究实施负责（组长）单位地址：

云南省昆明市东寺街158号

Primary sponsor's address：

No. 158, Dongsi Street, Kunming, Yunnan Province, 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)：

四川

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

成都欧林生物科技股份有限公司

具体地址：

四川省成都市高新区天欣路99号

Institution
hospital：

Chengdu Olymvax Biopharmaceuticals Inc.

Address：

99 Tianxin Road, Hi-Tech Zone, Chengdu, Sichuan

国家：

中国

省(直辖市)：

四川

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

成都新诺明生物科技有限公司

具体地址：

成都天府国际生物城D3栋(双流区生物城中路二段18号)

Institution
hospital：

Chengdu Xinnuomin Biotechnology Co. LTD

Address：

Building D3, Chengdu Tianfu International Bio-city (No. 18, Sec. 2, Bio-city Middle Road,

经费或物资来源：

成都欧林生物科技股份有限公司

Source(s) of funding：

Chengdu Olymvax Biopharmaceuticals Inc.

研究疾病：

预防疫苗相关型别流感病毒引起的流行性感冒  

Target disease：

Prevention of influenza caused by vaccine-associated influenza viruses

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的：评价三价流感病毒裂解疫苗（MDCK细胞）在6月龄及以上人群中接种的安全性。 次要目的：探索三价流感病毒裂解疫苗（MDCK细胞）在6月龄及以上人群中接种的免疫原性。 探索性目的：探索3-8岁不同流感疫苗接种史人群以不同免疫程序接种三价流感病毒裂解疫苗（MDCK细胞）的免疫原性。  

Objectives of Study：

Main Objective: To evaluate the safety of Trivalent Influenza Vaccine (Split Virion),Inactivated (MDCK Cell)administered in a population 6 months of age and older. Secondary Aim: To explore the immunogenicity of Trivalent Influenza Vaccine (Split Virion),Inactivated (MDCK Cell) administered in a population aged 6 months and older. Exploratory Aim: To explore the immunogenicity of Trivalent Influenza Vaccine (Split Virion),Inactivated (MDCK Cell) administered with different immunization schedules to populations aged 3-8 years with different influenza vaccination histories.

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6月龄； 2.受试者或受试者的法定监护人自愿同意参加试验（≥18岁受试者：受试者本人自愿同意参加试验，并签署知情同意书；8-17岁受试者：受试者本人和其法定监护人自愿同意参加试验，由其法定监护人/被委托人签署知情同意书，并由受试者本人签署未成年人知情同意书；6月龄-7岁受试者，受试者的法定监护人自愿同意孩子参加试验，由其法定监护人/被委托人签署知情同意书）； 3.受试者或受试者的法定监护人有能力了解试验程序，并能参加所有计划的随访； 4.入组当天腋温≤37.0℃。

Inclusion criteria

1. the age of 6 months; 2. the subject or the subject's legal guardian voluntarily agrees to participate in the trial (≥18 years old subject: the subject himself/herself voluntarily agrees to participate in the trial and signs the informed consent form; 8-17 years old subject: the subject himself/herself and his/her legal guardian voluntarily agrees to participate in the trial and his/her legal guardian/delegate signs the informed consent form, and the subject himself/herself signs the informed consent form of a minor; 6 months old - 7 years old (For subjects, the subject's legal guardian voluntarily agrees to the child's participation in the trial, and the informed consent form is signed by the subject's legal guardian/delegate); 3.the subject or the subject's legal guardian is capable of understanding the trial procedures and is able to attend all scheduled follow-up visits; 4.axillary temperature <= 37.0°C on the day of enrollment.

排除标准：

1.6-35月龄受试者入组前（从出生到入选当天）接种过任何流感疫苗或试验期间计划接种其他流感疫苗； 2.6-35月龄受试者接种前7天内患有发热性疾病，或接种前7天内使用解热镇痛药物和/或抗过敏和/或抗病毒药物； 3.6-35月龄、3-8岁受试者：生长发育异常者、严重湿疹者； 4.＜12月龄入组的受试者经诊断患有病理性黄疸或曾患病理性黄疸者； 5.＜12月龄入组的受试者早产（妊娠周数＜37周）、低体重（出生时体重<2500g）婴儿、因异常分娩等原因导致的严重新生儿疾病，如产伤、新生儿窒息、呼吸窘迫综合征、新生儿颅内出血等，或有窒息抢救史、神经器官损害史、严重慢性疾病史（如唐氏综合征、镰刀细胞贫血或神经疾患）者； 6.＜12月龄入组的受试者出生后接受过血液制品或免疫球蛋白，其余受试者与血液制品或免疫球蛋白使用间隔＜3个月；或计划在试验期间使用者（完成免后血样采集前）； 7.24月龄及以上人群血常规、血生化、尿常规指标异常且经研究者判定为有临床意义 8.3-8岁既往无接种史受试者入组前接种过任意流行季流感疫苗或试验期间计划接种其他流感疫苗，其余≥3岁受试者在既往1年内接种过任何流感疫苗（已注册的或试验性的）或在试验期间有计划接种任何其他流感疫苗； 9.≥3岁受试者接种前3天内患有发热性疾病，或接种前3天内使用解热镇痛药物和/或抗过敏和/或抗病毒药物； 10.≥18岁的受试者，患有药物不可控制的高血压（首次试验用疫苗接种前（当天）体检时血压异常：收缩压＞140mmHg和/或舒张压＞90mmHg）； 11.既往半年内患有流感疾病（经临床、血清学或微生物学任一方法确认的）； 12.任何已知或疑似对流感疫苗的任何成分过敏；或既往有任何疫苗或药物严重过敏反应史（包括过敏性休克、过敏性喉头水肿、过敏性紫癜、局部过敏性坏死反应等）； 13.患有急性疾病或处于慢性病的急性发作期； 14.癫痫，惊厥或抽搐史，或有遗传性精神病家族史； 15.自身免疫性疾病或免疫缺陷，或入组前3个月内长期使用免疫抑制剂或其它免疫调节药物（定义为连续使用超过14天），如全身性使用糖皮质激素（吸入性和局部类固醇激素不受限制）； 16.患有可能干扰试验进行或完成的严重的先天畸形或慢性疾病（包括但不限于：唐氏综合征、地中海贫血、心脏病、肝病、肾病、糖尿病、肿瘤、自身免疫病、遗传性过敏体质、格林巴利综合征等）； 17.入组前两年内病情不稳定的哮喘，或经紧急治疗、住院、插管、口服或静脉注射皮质类固醇治疗的哮喘； 18.无脾，功能性无脾，以及任何情况导致的无脾或脾切除； 19.存在肌肉注射禁忌症，例如：已被诊断为患有血小板减少症、任何凝血障碍或接受抗凝血剂治疗等； 20.试验前14天内接受过减毒活疫苗或新冠疫苗或7天内接受过其他疫苗者； 21.处于哺乳期、孕期或试验期间计划怀孕的女性，或育龄女性尿妊娠试验阳性； 22.＞8岁受试者入组前3个月内有酗酒、药物依赖、药物滥用及吸毒史者； 23.在试验期间参与其他临床试验的受试者（授权或未经许可的疫苗、药物、生物、器械或血液产品）； 24.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

Exclusion criteria：

1. subjects 6-35 months of age who have received any influenza vaccine prior to enrollment (from birth to the day of enrollment) or who are scheduled to receive another influenza vaccine during the trial; 2. subjects 6-35 months of age had a febrile illness within 7 days prior to vaccination, or were using antipyretic and analgesic medications and/or anti-allergic and/or antiviral medications within 7 days prior to vaccination; 3. 6-35 months old and 3-8 years old subjects: those with abnormal growth and development, and those with severe eczema; 4. subjects enrolled at <12 months of age who have been diagnosed with pathological jaundice or who have had pathological jaundice; 5. subjects enrolled at <12 months of age who were born prematurely (<37 weeks of gestation), low-birthweight (<2500g at birth) infants, severe neonatal illnesses due to abnormal deliveries and other causes, such as birth injuries, neonatal asphyxia, respiratory distress syndrome, intracranial hemorrhage in the newborn, or who have a history of asphyxia resuscitation, history of neurological organ damage, or a history of severe chronic illnesses (e.g., Down's Syndrome, Sickle Cell Anemia, or Neurological disorders; 6. Subjects enrolled at <12 months of age who have received blood products or immune globulin after birth, and the rest of the subjects who have <3 months interval between the use of blood products or immune globulin; or those who plan to use it during the trial period (prior to completing the collection of blood samples after immunization); 7. abnormalities in routine blood, blood biochemistry, and urinalysis in persons 24 months of age and older that are determined by the investigator to be clinically significant. 8. subjects aged 3-8 years with no prior vaccination history who have received any seasonal influenza vaccine prior to enrollment or have plans to receive any other influenza vaccine during the trial period, and the remaining subjects ≥3 years of age who have received any influenza vaccine (registered or experimental) within the past 1 year or have plans to receive any other influenza vaccine during the trial period; 9. subjects >=3 years of age with a febrile illness within 3 days prior to vaccination, or use of antipyretic and analgesic medications and/or anti-allergic and/or antiviral medications within 3 days prior to vaccination; 10. subjects >= 18 years of age with medically uncontrollable hypertension (abnormal blood pressure: systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg on physical examination prior to (on the day of) the first experimental vaccination); 11. Influenza disease (confirmed by any of the clinical, serologic or microbiologic methods) within the previous 6 months; 12. any known or suspected allergy to any component of influenza vaccine; or previous history of severe allergic reaction to any vaccine or drug (including anaphylaxis, anaphylactoid laryngeal edema, anaphylactoid purpura, localized anaphylactic necrotic reaction, etc.); 13. suffering from an acute illness or in the acute exacerbation phase of a chronic disease; 14. epilepsy, history of convulsions or seizures, or a family history of hereditary psychosis 15. autoimmune disease or immunodeficiency, or chronic use of immunosuppressants or other immunomodulatory drugs (defined as use for more than 14 consecutive days), such as systemic use of glucocorticoids (inhaled and topical steroids are not restricted), within 3 months prior to enrollment; 16. Suffering from serious congenital anomalies or chronic diseases that may interfere with the conduct or completion of the trial (including but not limited to: Down syndrome, thalassemia, heart disease, liver disease, kidney disease, diabetes mellitus, tumors, autoimmune diseases, hereditary allergies, Guillain-Barre syndrome, etc.); 17. asthma that has been unstable for two years prior to enrollment, or asthma that has been treated with emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids; 18. absence of spleen, functional absence of spleen, and any condition resulting in absence of spleen or splenectomy; 19. the presence of contraindications to intramuscular injection, e.g., having been diagnosed with thrombocytopenia, any coagulation disorder, or receiving anticoagulant therapy; 20. who have received a live attenuated or new coronary vaccine within 14 days or another vaccine within 7 days prior to the trial; 21. females who are breastfeeding, pregnant or planning to become pregnant during the trial, or females of childbearing age with a positive urine pregnancy test; 22. subjects >8 years of age with a history of alcoholism, drug dependence, drug abuse and drug addiction within 3 months prior to enrollment; 23. subjects participating in other clinical trials during the trial period (licensed or unlicensed vaccines, drugs, biologicals, devices or blood products); 24. any other factor that, in the judgment of the investigator, makes the subject unsuitable for participation in a clinical trial

研究实施时间：

Study execute time：

从 From 2025-02-10 00:00:00至 To 2025-08-10 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-02-10 00:00:00 至 To 2025-08-10 00:00:00

干预措施：

Interventions：

组别：

试验疫苗组

样本量：

 120

Group：

Experimental vaccine group

Sample size：

干预措施：

9岁及以上组受试者全程接种1剂； 3-8岁既往无流感疫苗接种史试验组受试者全程接种2剂（0、28天），既往有流感疫苗接种史受试者全程接种1剂； 6-35月龄受试者全程接种2剂（0、28天）。

干预措施代码：

Intervention：

Subjects in the 9 years and older group received 1 full dose; Subjects in the 3-8 years old test group with no prior history of influenza vaccination received 2 full doses (days 0 and 28), and subjects with prior history of influenza vaccination received 1 full dose; Subjects 6-35 months of age received 2 doses (0 and 28 days).

Intervention code：

组别：

对照疫苗组1

样本量：

 80

Group：

Control vaccine group 1

Sample size：

干预措施：

9岁及以上组受试者全程接种1剂； 3-8岁既往有流感疫苗接种史受试者全程接种1剂；

干预措施代码：

Intervention：

Subjects in the 9 years and older group received 1 full dose; Subjects aged 3-8 years with a history of previous influenza vaccination received one full dose;

Intervention code：

组别：

对照疫苗组2

样本量：

 20

Group：

Control vaccine group 2

Sample size：

干预措施：

6-35月龄受试者全程接种2剂（0、28天）

干预措施代码：

Intervention：

Subjects 6-35 months of age received 2 doses (0 and 28 days).

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 云南 

市(区县)：

  

Country：

China

Province：

Yunnan

City：

单位(医院)：

 祥云县疾病预防控制中心 

单位级别：

 N/A 

Institution
hospital：

Xiangyun County Center for Disease Control and Prevention

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

任何局部和全身不良事件（AE）/不良反应发生率

指标类型：

主要指标

Outcome：

Any local and systemic adverse event (AE)/incidence of adverse reactions

Type：

Primary indicator

测量时间点：

每剂接种后30分钟内/0-7天内/0-28天内

测量方法：

Measure time point of outcome：

Within 30 minutes/ 0-7 days/0-28 days after each dose of vaccination

Measure method：

指标中文名：

严重不良事件和严重不良反应发生率

指标类型：

主要指标

Outcome：

Incidence of serious adverse events and serious adverse reactions

Type：

Primary indicator

测量时间点：

首剂接种至全程免后6个月内

测量方法：

Measure time point of outcome：

First dose up to 6 months after full immunization

Measure method：

指标中文名：

实验室检测指标异常发生率

指标类型：

主要指标

Outcome：

Incidence of abnormal laboratory test indicators

Type：

Primary indicator

测量时间点：

24月龄及以上受试者（每剂）接种后第4天较首剂接种前

测量方法：

Measure time point of outcome：

Subjects 24 months of age and older (per dose) on day 4 after vaccination compared to before the first dose of vaccination

Measure method：

指标中文名：

各型别HI抗体GMT、阳转率（SCR）、血清保护率（SPR）和GMT增长倍数（GMI）

指标类型：

次要指标

Outcome：

GMT, positive conversion rate (SCR), seroprotection rate (SPR) and GMT growth multiplier (GMI) of HI antibodies by type

Type：

Secondary indicator

测量时间点：

全程免后28天

测量方法：

Measure time point of outcome：

28 days after full immunization

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 0.5 岁 years
最大 Max age 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）：

由随机化统计师采用SAS（9.4及以上版本），对不同年龄层（18-59岁、60岁及以上、9-17岁、3-8岁（既往有接种史）、6-35月龄）采用区组随机化方法产生随机表，筛选合格的受试者将按照1:1的比例随机分配接种试验疫苗或对照疫苗。 3-8岁无流感疫苗接种史人群，按照0、28天免疫程序接种2剂试验疫苗，不进行随机。

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

A randomization table will be generated by a randomization statistician using SAS (version 9.4 and above) using block group randomization for different age groups (18-59 years, 60 years and above, 9-17 years, 3-8 years (with previous vaccination history), and 6-35 months of age), and screened subjects will be randomly assigned to receive the trial vaccine or the control vaccine in a 1:1 ratio. Those 3-8 years of age with no history of influenza vaccination will receive 2 doses of the test vaccine according to the 0 and 28 day immunization schedule and will not be randomized.

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：

本试验采用盲法设计。由申办者提供试验疫苗和对照疫苗，由随机化统计师对试验用疫苗进行编盲，即按照盲底将打印好的疫苗标签粘贴于每份疫苗指定位置。完成编盲后，盲底由非盲团队封存。编盲人员不得参加本临床试验的其他相关工作，同时也不得向参加本临床试验工作的任何人员泄露盲底。 备用疫苗的编盲操作与试验用疫苗的编盲操作相同。

Blinding：

The trial was a blinded design. The trial and control vaccines were provided by the sponsor, and the randomization statistician blinded the trial vaccines, i.e., printed vaccine labels were attached to each vaccine at a designated location according to the blinded background. Upon completion of the blinding, the blind base will be sealed by the non-blinded team. Blinders are not allowed to take part in any other work related to the clinical trial, and they are not allowed to disclose the blinds to any person who participates in the clinical trial. The blinding operation of the backup vaccine is the same as that of the trial vaccine.

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）：

无

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

None

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：

电子数据采集和管理系统

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

Electronic Data Capture(EDC)

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-02-05 08:42:31