NCT07418372尚未招募1 期
A Randomized, Double-Blind, Parallel-Controlled Phase I/II Clinical Trial Evaluating the Safety and Immunogenicity of Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) Among Individuals Aged 6 Years and Above
Institute of Medical Biology, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 660 人开始时间: 2026年3月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- Safety index - incidence of adverse events
研究概览
简要总结
This is a randomized, double-blinded, parallel-controlled phase I/II clinical trial to evaluate the safety and preliminary immunogenicity of the Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (reduced antigen content) in subjects aged 6 years and above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age Requirement: volunteers aged 6 years and above
- •Provision of Legal Identification: volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- •Informed Consent: participants, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
排除标准
- •Subjects whose physical examination, vital signs check, or laboratory test results are abnormal and have clinical significance, and are determined by the researcher to be unsuitable for participation in the clinical trial.
- •Subjects who have received any vaccine within 30 days (including the 30th day) before enrollment, or those who plan to receive other vaccines within 30 days (including the 30th day) after receiving the investigational vaccine.
- •Subjects who have experienced acute diseases (such as fever) or acute exacerbations of chronic diseases within 3 days before enrollment (including the third day).
- •Subjects who have had contact with patients clearly diagnosed with pertussis, diphtheria or tetanus within 30 days before enrollment.
- •Individuals who have been clinically diagnosed with diphtheria or tetanus within 10 years before enrollment, or with pertussis within 5 years; or those who have experienced paroxysmal spasmodic coughing for at least 14 days without fever within 5 years, and for which no other specific cause (such as influenza) can be identified, and have a history of exposure to pertussis or contact with confirmed cases.
- •Subjects who have been diagnosed with serious diseases that may interfere with the conduct or completion of the trial.
- •Subjects who have shown allergic reactions to any component of the trial vaccine (such as aluminum adjuvant) before enrollment, or have experienced severe allergic reactions, suspected severe allergies (such as Arthus reaction, anaphylactic shock, laryngeal edema, allergic purpura, local allergic necrotic reaction, etc.) or other serious adverse reactions (such as thrombocytopenic purpura, breathing difficulties, angioneurotic edema, widespread rash, brachial plexus neuritis, etc.) to any vaccine or drug before enrollment.
- •Subjects who have experienced convulsions, epilepsy, mental disorders before enrollment, or have a family history of such diseases, or have had severe brain diseases (such as hypoxic-ischemic encephalopathy, intracranial hemorrhage, cerebral palsy, intracranial tumors, cerebral infarction, stroke, etc.) before enrollment.
- •Subjects with coagulation disorders (such as deficiency of coagulation factors, coagulation diseases, and platelet abnormalities), or a history of bleeding disorders, or those with hereditary bleeding tendencies.
- •Individuals with primary or secondary immune function impairment, or those who have been receiving immunosuppressive therapy for a long time (such as long-term systemic glucocorticoid treatment, for example, using prednisone or similar drugs for two weeks or more continuously, but local use such as ointments, eye drops, inhalants or nasal sprays is allowed), or those who plan to use it during the trial.
- •Subjects who have had their spleen removed or undergone partial or complete removal of other vital organs (such as the liver, kidneys, lungs, pancreas, thyroid, stomach, intestines, and other vital organs) due to any cause.
- •Subjects who have donated blood or lost blood (≥ 400 ml) within 6 months before enrollment, received blood transfusion or used blood products, or plan to receive blood transfusion or use blood products during the trial.
- •Any investigational or unregistered products (drugs, biologics or devices) were used within 6 months before enrollment, or the subject plans to participate in or is currently participating in any clinical trial.
- •Subjects who may be unable to follow the trial procedures, abide by the agreement, or plan to permanently relocate from this area during the trial period, or be away from the local area for a long time during the scheduled visits.
- •Subjects deemed by the investigator to be unsuitable for participation in the study.
研究组 & 干预措施
low-dose experimental group
Experimental
Participants aged 6 years and above
干预措施: low-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) (Biological)
high-dose experimental group
Experimental
Participants aged 6 years
干预措施: high-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) (Biological)
DTaP controlled group
Active Comparator
Participants aged 6 years
干预措施: Tetanus, Diphtheria and Acellular Pertussis Vaccine (Biological)
PPV23 controlled group
Placebo Comparator
Participants aged 7 years and above
干预措施: 23-valent polysaccharide pneumococcal vaccine (Biological)
结局指标
主要结局
Safety index - incidence of adverse events
时间窗: 0- 30 minutes/Day 0 to 7 days/Day 0 to 28 days after vaccination
Incidence of adverse events after vaccination
Immunogenicity index - Geometric Mean Concentration (GMC)
时间窗: Day 30 after vaccination
The GMC of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination
Immunogenicity index - Seropositive Rate
时间窗: Day 30 after vaccination
The seropositve rate of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination
次要结局
- Safety index - incidence of serious adverse events(From vaccination to 12 months after vaccination)
- Immunogenicity index - Seroconversion Rate(Between baseline and Day 30 after vaccination)
- Immunogenicity index - Geometric mean fold increases (GMFI)(Between baseline and Day 30 after vaccination)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCANCT07282353Cascade Pharmaceuticals, Inc135
尚未招募
2 期
A Phase 2 Study to Evaluate the Efficacy and Safety of LY03020 in Acutely Psychotic Participants With SchizophreniaSchizophreniaNCT07396870Luye Pharma Group Ltd.160
招募中
1 期
A Study of BEBT-701 in Patients With Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol（LDL-C）NCT07368608BeBetter Med Inc340
招募中
2 期
A Study of SHR-2173 in Participants With Primary IgA NephropathyNCT07354932Guangdong Hengrui Pharmaceutical Co., Ltd84
招募中
2 期
A Study to Evaluate 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)NCT07292714Mabwell (Shanghai) Bioscience Co., Ltd.360