ChiCTR2600117560 版本V1.0 版本创建时间2026/01/26 16:16:50 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：

 ChiCTR2600117560 

最近更新日期：

Date of Last Refreshed on：

 2026-01-26 16:16:20 

注册时间：

Date of Registration：

 2026-01-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评价吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌（结合）联合疫苗在不同年龄健康婴幼儿及儿童中接种的安全性及初探免疫原性的I期临床试验

Public title：

Evaluation of the Safety and Preliminary Immunogenicity of the Adsorbed Acellular Diphtheria, Tetanus, Pertussis, Inactivated Poliomyelitis, and Haemophilus influenzae Type b (Conjugate) Combined Vaccine in Healthy Infants and Children of Different Ages: A Phase I Clinical Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌（结合）联合疫苗在不同年龄健康婴幼儿及儿童中接种的安全性及初探免疫原性的I期临床试验

Scientific title：

Evaluation of the Safety and Preliminary Immunogenicity of the Adsorbed Acellular Diphtheria, Tetanus, Pertussis, Inactivated Poliomyelitis, and Haemophilus influenzae Type b (Conjugate) Combined Vaccine in Healthy Infants and Children of Different Ages: A Phase I Clinical Trial

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：

李庆亮 

研究负责人：

官旭华 

Applicant：

Qingliang Li 

Study leader：

Xuhua Guan 

申请注册联系人电话：

Applicant telephone：

 +86 159 2631 5343

研究负责人电话：

Study leader's
telephone：

+86 138 7124 4927

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：

 lqlwibp@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 552371433@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：

湖北省武汉市江夏区郑店街黄金工业园路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：

No.1, Huangjin Industrial Park Road, Zhengdian Street, Jiangxia District, Wuhan, Hubei

Study leader's address：

No.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：

武汉生物制品研究所有限责任公司

Applicant's institution：

Wuhan Biological Products Research Institute 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：

Hubei 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：

 2025-050-03

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 Hubei Provincial Center for Disease Control and Prevention (Hubei Academy of Preventive Medicine)

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-12-22 00:00:00

伦理委员会联系人：

沈恒

Contact Name of the ethic committee：

Heng Shen

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 2129

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：

Hubei Provincial Center for Disease Control and Prevention

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)：

湖北

市(区县)：

武汉

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

武汉生物制品研究所有限责任公司

具体地址：

江夏区黄金工业园路1号

Institution
hospital：

Wuhan Institute of Biological Products Co., Ltd.

Address：

1 Huangjin'gongyeyuan Road, Jiangxia District

经费或物资来源：

企业自有资金

Source(s) of funding：

The company's own funds

研究疾病：

百日咳、白喉、破伤风、脊髓灰质炎、b型流感嗜血杆菌感染的五种感染性疾病  

Target disease：

Pertussis, Diphtheria, Tetanus, Poliomyelitis, and Haemophilus influenzae type b infection

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：

 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：

主要目的 评价DTacP-sIPV/Hib在2月龄健康婴儿中按2,4,6月龄接种3剂以及18~24月龄加强接种1剂、6岁健康儿童和18~24月龄健康幼儿中接种1剂的安全性。 次要目的 初步观察6岁儿童、18~24月龄幼儿接种1剂DTacP-sIPV/Hib后30天抗PT、FHA、PRN、DT和TT抗体、抗脊髓灰质炎Ⅰ、Ⅱ、Ⅲ型中和抗体和抗Hib-PRP抗体的阳性率、阳转率、GMC/GMT、GMI； 初步观察2月龄婴儿接种4剂DTacP-sIPV/Hib后30天抗PT、FHA、PRN、DT和TT抗体、抗脊髓灰质炎Ⅰ、Ⅱ、Ⅲ型中和抗体和抗Hib-PRP抗体的阳性率、阳转率、GMC/GMT、GMI。 探索性目的 初步观察2月龄婴儿接种4剂DTacP-sIPV/Hib后12个月和24个月抗PT、FHA、PRN、DT和TT抗体、抗脊髓灰质炎Ⅰ、Ⅱ、Ⅲ型中和抗体和抗Hib-PRP抗体的阳性率、GMC/GMT。  

Objectives of Study：

Primary Objective? To evaluate the safety of DTacP-sIPV/Hib administered as a 3-dose primary series at 2, 4, and 6 months of age plus a booster dose at 18-24 months of age in healthy infants, and as a single dose in healthy children aged 6 years and healthy toddlers aged 18-24 months. Secondary Objectives To preliminarily observe the seropositivity rate, seroconversion rate, geometric mean concentration/geometric mean titer (GMC/GMT), and geometric mean increase (GMI) of antibodies against PT, FHA, PRN, DT, and TT, neutralizing antibodies against poliovirus types I, II, and III, and anti-Hib-PRP antibodies at 30 days after a single dose of DTacP-sIPV/Hib in children aged 6 years and toddlers aged 18-24 months. To preliminarily observe the seropositivity rate, seroconversion rate, geometric mean concentration/geometric mean titer (GMC/GMT), and geometric mean increase (GMI) of antibodies against PT, FHA, PRN, DT, and TT, neutralizing antibodies against poliovirus types I, II, and III, and anti-Hib-PRP antibodies at 30 days after the fourth dose of DTacP-sIPV/Hib in infants starting the vaccination at 2 months of age. Exploratory Objectives To preliminarily observe the seropositivity rate and geometric mean concentration/geometric mean titer (GMC/GMT) of antibodies against PT, FHA, PRN, DT, and TT, neutralizing antibodies against poliovirus types I, II, and III, and anti-Hib-PRP antibodies at 12 and 24 months after the fourth dose of DTacP-sIPV/Hib in infants starting the vaccination at 2 months of age.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

首剂入选标准： 1)年龄范围：6岁儿童，18~24月龄幼儿、2月龄婴儿； 2)6岁儿童按照免疫规划程序完成4剂百白破疫苗或含百白破成分联合疫苗并可提供接种记录，且未接种第5剂吸附无细胞百白破联合疫苗； 3)18~24月龄幼儿按照免疫规划程序已完成百白破疫苗和脊髓灰质炎疫苗基础免疫（3剂）并可提供接种记录，且未进行百白破疫苗、脊髓灰质炎疫苗和Hib疫苗的加强免疫； 4)2月龄婴儿未接种脊髓灰质炎疫苗、百白破疫苗、Hib疫苗、A群C群脑膜炎球菌多糖结合疫苗、13价肺炎球菌多糖结合疫苗等以白喉或破伤风类毒素作为载体的结合疫苗； 5)法定监护人或被委托人经知情同意，自愿签署知情同意书，能够遵守临床试验方案的要求。 加强免疫阶段入选标准： 1)2月龄试验参与者已完成本临床试验3剂基础免疫接种，年龄为18~24月龄，且未进行百白破疫苗、脊髓灰质炎疫苗（C4组除外）和Hib疫苗（C2、C4组除外）的加强免疫； 2)根据研究者的意见，试验参与者法定监护人/被委托人能遵守临床试验方案的要求。

Inclusion criteria

Inclusion criteria for the first dose: 1. Age range: children aged 6 years, toddlers aged 18~24 months, and infants aged 2 months; 2. Children aged 6 years have completed the 4-dose primary series of the diphtheria, tetanus, and pertussis vaccine or combined vaccines containing the diphtheria-tetanus-pertussis component according to the national immunization schedule, can provide vaccination records, and have not received the fifth dose of the adsorbed acellular diphtheria, tetanus, and pertussis combined vaccine; 3. Toddlers aged 18~24 months have completed the primary immunization (3 doses) against diphtheria, tetanus, pertussis, and poliomyelitis according to the national immunization schedule, can provide vaccination records, and have not received the booster doses for the diphtheria-tetanus-pertussis vaccine, poliovirus vaccine, or Haemophilus influenzae type b (Hib) vaccine; 4. Infants aged 2 months have not been vaccinated with the poliovirus vaccine, diphtheria-tetanus-pertussis vaccine, Haemophilus influenzae type b (Hib) vaccine, group A and C meningococcal polysaccharide conjugate vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, or other conjugate vaccines that use diphtheria or tetanus toxoid as a carrier; 5. The legal guardian or their delegate, after being informed and providing consent, voluntarily signs the informed consent form and is capable of complying with the requirements of the clinical trial protocol; Booster immunization phase inclusion criteria: 1.Participants who received the first dose at 2 months of age must have completed the 3-dose primary vaccination series of this clinical trial, be between 18 and 24 months of age at the time of the booster, and must not have received a booster dose of the diphtheria, tetanus, and pertussis (DTaP) vaccine, the inactivated poliovirus vaccine (IPV) (except for those in Group C4), and the Haemophilus influenzaetype b (Hib) vaccine (except for those in Groups C2 and C4); 2.In the investigator's judgment, the participant's legal guardian or their delegate is capable of complying with the requirements of the clinical trial protocol.

排除标准：

首剂排除标准： 1)有百日咳、白喉、破伤风、脊髓灰质炎、b型流感嗜血杆菌感染病史；在过去30天内，曾与确诊百日咳、白喉、脊髓灰质炎、b型流感嗜血杆菌感染的个体发生接触者； 2)依据试验参与者出生证明：2月龄婴儿早产（妊娠第37周之前分娩）、过期产（妊娠第42周之后分娩）、出生体重不达标（<2500克）；有产程异常、窒息抢救史、难产、神经系统损害史者； 3)有严重的先天畸形或发育障碍、遗传缺陷，严重营养不良、生长发育异常者等； 4)有癫痫、惊厥、抽搐、脑瘫病史者，或有精神病史或家族史；或其他进行性神经系统疾病者； 5)2个月内接受免疫增强或抑制剂治疗者（持续口服或滴注超过14天），或吸入性、鼻喷剂、关节内、滴眼液、软膏等局部类固醇用药超过说明书中推荐的剂量； 6)已被诊断为患有先天性或获得性免疫缺陷、淋巴瘤、白血病或其他自身免疫疾病； 7)任何情况导致的无脾，脾脏功能缺陷； 8)已知或怀疑患有严重慢性疾病（包括：严重呼吸系统疾病、严重心血管疾病、肝肾疾病、严重皮肤病、恶性肿瘤、严重湿疹及重度黄疸者等）； 9)经过医生诊断的凝血功能异常史（如凝血因子缺乏，凝血性疾病）； 10)既往接种其他疫苗后发生与疫苗有关的高热（腋下温度≥39.5℃），伴或不伴惊厥； 11)有疫苗接种严重过敏反应史，如呼吸困难、广泛荨麻疹； 12)对试验用疫苗的任何成份过敏； 13)6岁儿童、18~24月龄幼儿接种前实验室检测指标异常且经临床医生判定有临床意义者； 14)正在或计划参加其他临床试验； 15)研究者判断其他不适合参加本临床试验的情况。 注：2月龄所有试验参与者入组后，按当地免疫规划对接种13价肺炎球菌多糖结合疫苗、脑膜炎球菌结合疫苗不进行限制，但与试验用疫苗接种间隔均应符合方案要求；应急接种不受限制。 第二、三剂次接种排除标准： 1)在前一剂接种疫苗后发生严重超敏反应者； 2)与前一剂疫苗接种有因果关系的严重不良事件者； 3)第一次接种后新发现或新发生的不符合首剂入选标准或符合首剂排除标准者，由研究者判定是否继续参与试验； 4)前一剂试验用疫苗接种后接种过脊髓灰质炎疫苗（C4组除外）、百白破疫苗、Hib疫苗（C2、C4组除外）； 5)研究者认为的其他的排除原因。 加强免疫接种排除标准 1)基础免疫后发生严重过敏反应者； 2)与基础免疫有因果关系的严重不良事件者； 3)新发现或新发生的不符合首剂入选标准或符合首剂排除标准者，由研究者判定是否继续参与试验； 4)研究者认为的其他的排除原因。

Exclusion criteria：

Exclusion criteria for the first dose: 1.History of pertussis, diphtheria, tetanus, poliomyelitis, or Haemophilus influenzae type b infection; or contact with an individual diagnosed with pertussis, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection within the past 30 days; 2. For the 2-month-old infant participants, as per the birth certificate: preterm birth (delivery prior to 37 weeks of gestation), postterm birth (delivery after 42 weeks of gestation), or birth weight <2500 grams; or history of dystocia, birth asphyxia requiring resuscitation, or neurological impairment; 3. Presence of severe congenital malformations, developmental disorders, genetic defects, severe malnutrition, or abnormal growth and development; 4. History of epilepsy, convulsions, seizures, cerebral palsy, personal or family history of psychiatric disorders, or other progressive neurological diseases; 5. Treatment with immunopotentiators or immunosuppressive agents (continuous oral or intravenous infusion for more than 14 days) within the past 2 months; or use of topical steroids (e.g., inhaled, intranasal, intra-articular, ophthalmic drops, ointments) exceeding the doses recommended in the product; 6. Diagnosed with congenital or acquired immunodeficiency, lymphoma, leukemia, or other autoimmune diseases; 7. Asplenia from any cause, or functional hyposplenia ; 8. Known or suspected severe chronic diseases (including but not limited to: severe respiratory diseases, severe cardiovascular diseases, hepatic or renal diseases, severe skin conditions, malignancy, severe eczema, or severe jaundice, etc.); 9. Medically diagnosed history of coagulation disorders (e.g., coagulation factor deficiencies, coagulopathy) ; 10. History of vaccine-related high fever (axillary temperature >=39.5°C), with or without convulsions, following previous vaccination(s); 11. History of severe allergic reactions to vaccines, such as dyspnea, or generalized urticaria; 12. Allergy to any component of the investigational vaccine; 13. For children aged 6 years and toddlers aged 18-24 months: abnormal laboratory test results prior to vaccination deemed clinically significant by the clinical investigator; 14. Currently participating or planning to participate in other clinical trials; 15. Any other condition considered by the investigator as inappropriate for participation in this clinical trial; Note: For all 2-month-old infant participants after enrollment, vaccination with the 13-valent pneumococcal polysaccharide conjugate vaccine and meningococcal conjugate vaccine according to the local immunization schedule is not restricted, provided the intervals between these vaccinations and the investigational vaccine administration comply with the protocol requirements; emergency vaccinations are not restricted. Exclusion criteria for the second and third doses: 1.Participants who experienced severe hypersensitivity reactions after the previous dose of the investigational vaccine. 2.Participants who experienced serious adverse events determined to be causally related to the previous dose of the investigational vaccine. 3.New conditions identified or developed after the first dose that render the participant ineligible according to the initial inclusion criteria or eligible according to the initial exclusion criteria. The investigator will assess whether the participant can continue in the trial. 4.Receipt of poliovirus vaccine (except for participants in Group C4), diphtheria, tetanus, and pertussis (DTaP) vaccine, or Hib vaccine (except for participants in Groups C2 and C4) after the previous dose of the investigational vaccine. 5.Any other reason deemed by the investigator as grounds for exclusion. Exclusion criteria for booster immunization: 1.Participants who experienced severe allergic reactions following the primary vaccination series; 2.Participants who experienced serious adverse events determined to be causally related to the primary vaccination series; 3.New conditions identified or developed after the primary series that render the participant ineligible according to the initial inclusion criteria or eligible according to the initial exclusion criteria. The investigator will assess whether the participant can receive the booster; 4.Any other reason deemed by the investigator as grounds for exclusion from booster immunization.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2030-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-01-31 00:00:00 至 To 2026-08-31 00:00:00

干预措施：

Interventions：

组别：

6岁A组

样本量：

 20

Group：

6 years(Group A)

Sample size：

干预措施：

DTacP-sIPV/Hib（WIBP）；接种1剂

干预措施代码：

Intervention：

DTacP-sIPV/Hib(WIBP), Receive a single dose

Intervention code：

组别：

18~24月龄B1组

样本量：

 20

Group：

18~24months(Group B1)

Sample size：

干预措施：

DTacP-sIPV/Hib（WIBP）；接种1剂

干预措施代码：

Intervention：

DTacP-sIPV/Hib(WIBP), Receive a single dose

Intervention code：

组别：

18~24月龄B2组

样本量：

 20

Group：

18~24months(Group B2)

Sample size：

干预措施：

DTacP-IPV/Hib（PENTAXIM）；接种1剂

干预措施代码：

Intervention：

DTacP-IPV/Hib(PENTAXIM); Receive a single dose

Intervention code：

组别：

2月龄C1组

样本量：

 30

Group：

2 months(Group C1)

Sample size：

干预措施：

DTacP-sIPV/Hib（WIBP）；按照2,4,6,18~24月龄程序各接种1剂

干预措施代码：

Intervention：

DTacP-sIPV/Hib(WIBP),Administered as one dose each at 2, 4, 6, and 18~24 months of age

Intervention code：

组别：

2月龄C2组

样本量：

 30

Group：

2 months(Group C2)

Sample size：

干预措施：

DTaP+sIPV；按照2,4,6,18~24月龄程序分别同时1剂DTaP和sIPV

干预措施代码：

Intervention：

DTaP+sIPV,Administer one dose each of DTaP and sIPV concurrently according to the 2, 4, 6, and 18~24 months of age schedule

Intervention code：

组别：

2月龄C3组

样本量：

 30

Group：

2 months(Group C3)

Sample size：

干预措施：

DTacP-IPV/Hib（PENTAXIM）；按照2,4,6,18~24月龄程序各接种1剂

干预措施代码：

Intervention：

DTacP-IPV/Hib(PENTAXIM),Administered as one dose each at 2, 4, 6, and 18~24 months of age

Intervention code：

组别：

2月龄C4组

样本量：

 30

Group：

2 months(Group C4)

Sample size：

干预措施：

DTacP（WIBP）；按照2,4,6,18~24月龄程序各接种1剂

干预措施代码：

Intervention：

DTacP(WIBP),Administered as one dose each at 2, 4, 6, and 18~24 months of age

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)：

 湖北省疾病预防控制中心 

单位级别：

 无 

Institution
hospital：

Hubei Provincial Center for Disease Prevention and Control

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

抗PT、FHA、PRN、DT和TT抗体以及抗脊髓灰质炎病毒Ⅰ型、Ⅱ型和Ⅲ型中和抗体和抗Hib-PRP抗体阳性率

指标类型：

主要指标

Outcome：

The positive rate of anti-PT, FHA, PRN, DT and TT antibodies;neutralizing antibodies against poliovirus types I, II, and III;and Anti-Hib-PRP 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：

抗PT、FHA、PRN、DT和TT抗体以及抗脊髓灰质炎病毒Ⅰ型、Ⅱ型和Ⅲ型中和抗体和抗Hib-PRP抗体阳转率

指标类型：

主要指标

Outcome：

The seroconversion rate of anti-PT, FHA, PRN, DT and TT antibodies;neutralizing antibodies against poliovirus types I, II, and III;and Anti-Hib-PRP 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：

抗PT、FHA、PRN、DT和TT抗体以及抗脊髓灰质炎病毒Ⅰ型、Ⅱ型和Ⅲ型中和抗体和抗Hib-PRP抗体GMC/GMT

指标类型：

主要指标

Outcome：

The GMC/GMT of anti-PT, FHA, PRN, DT and TT antibodies;neutralizing antibodies against poliovirus types I, II, and III;and Anti-Hib-PRP 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：

抗PT、FHA、PRN、DT和TT抗体以及抗脊髓灰质炎病毒Ⅰ型、Ⅱ型和Ⅲ型中和抗体和抗Hib-PRP抗体GMI

指标类型：

主要指标

Outcome：

The GMI of anti-PT, FHA, PRN, DT and TT antibodies;neutralizing antibodies against poliovirus types I, II, and III;and Anti-Hib-PRP 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：

0-7天征集性不良事件发生率

指标类型：

副作用指标

Outcome：

Incidence of solicited adverse events within 0-7 days

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

0-30天非征集性不良事件发生率

指标类型：

副作用指标

Outcome：

Incidence of unsolicited adverse events within 0-30 days

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

首剂接种至全程免后12个月严重不良事件发生率

指标类型：

副作用指标

Outcome：

Incidence of serious adverse events from the first dose up to 12 months after the complete vaccination course

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

实验室检测指标异常情况

指标类型：

副作用指标

Outcome：

Abnormalities in laboratory test parameters

Type：

Adverse events

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：

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 岁 years
最大 Max age 6 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）：

本研究按试验参与者年龄风险将试验分三个阶段实施，第一阶段（年龄组1）采用单臂、开放设计，第二阶段（年龄组2）与第三阶段（年龄组3）采用随机、对照、双盲设计。第二阶段（年龄组2）与第三阶段（年龄组3）的试验参与者随机表由随机化统计师应用SAS 9.4或以上版本统计软件，采用区组随机的方法产生，年龄组2的试验参与者（B：18~24月龄组）将按照1:1的比例随机分配到B1和B2组，每组各20例试验参与者；年龄组3的试验参与者（C：2月龄组）将按照1:1:1:1的比例随机分配到C1、C2、C3、C4组，每组各30例试验参与者。

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

This study was conducted in three stages based on the age-related risk of the participants. The first stage (Age Group 1) adopted a single-arm, open-label design, while the second stage (Age Group 2) and the third stage (Age Group 3) employed a randomized, controlled, double-blind design.The randomization schedule for participants in the second stage (Age Group 2) and the third stage (Age Group 3) was generated by a randomization statistician using SAS software version 9.4 or higher, utilizing the block randomization method Participants in Age Group 2 (B: 18~24 months old group) were randomly assigned in a 1:1 ratio to either group B1 or group B2, with 20 participants in each group.Participants in Age Group 3 (C: 2 months old group) were randomly assigned in a 1:1:1:1 ratio to groups C1, C2, C3, and C4, with 30 participants in each group.

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：

本试验分三阶段，第一阶段采用单臂、开放试验设计；第二阶段与第三阶段将采用双盲设计，设置非盲接种人员在非盲区完成疫苗配制和复核，由疫苗接种人员完成接种，保证研究者和试验参与者、数据管理、统计分析等项目相关人员均不知道接种的是何种疫苗。第三阶段因C2组试验参与者需同时接种DTaP和sIPV；C4组的试验参与者需要按照计划免疫要求接种IPV疫苗，在第8天根据CTMS系统刮刮卡结果告知试验参与者是否需要自行接种IPV，故无法实现完全盲态化，将尽量保证其他项目成员，如安全性随访者等按照试验盲法实施规定保持盲态。

Blinding：

This trial is divided into three stages. The first stage adopts a single-arm, open-label design; the second and third stages will employ a double-blind design. Unblinded vaccinators will perform vaccine preparation and verification in a designated unblinded area, and the vaccination will be administered by vaccinators. This process ensures that the investigators, trial participants, data management team, statistical analysts, and other relevant personnel remain unaware of which vaccine is administered.In the third stage, complete blinding cannot be achieved because participants in Group C2 need to receive DTaP and sIPV simultaneously, and participants in Group C4 need to receive the IPV vaccine according to the planned immunization requirements. On Day 8, based on the CTMS system scratch card results, participants in Group C4 will be informed whether they need to self-administer the IPV vaccine. Therefore, efforts will be made to ensure that other project team members, such as those conducting safety follow-ups, maintain their blinded status in accordance with the trial blinding implementation rules.

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）：

文章发表后6个月，ResMan临床试验公共管理平台

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

Six months after the article was published, the ResMan clinical trial public management platform

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：

电子病例报告表（eCRF）和CTMS数据管理系统

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

electronic case report form and CTMS electronic database

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-01-26 16:16:20