NCT06817187已完成3 期
A Single Center, Randomized, Open Label, Controlled Clinical Study to Evaluate the Mutual Influence of Combined Administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular Pertussis (Component) Combined Vaccine (Adsorbed)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,110
- 试验地点
- 1
- 主要终点
- Antibody positive conversion rate
研究概览
简要总结
This clinical study aims to evaluate the mutual influence of combined administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine in the target population
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants aged 3 months (90-119 days old), full-term (37-42 weeks pregnant), with a birth weight of ≥ 2.5kg;
- •The legal guardian provides informed consent and signs the informed consent form;
- •The legal guardian agrees to comply with the requirements of the clinical research protocol, is willing to accept a follow-up of 10 months, and has the ability to use thermometers, scales, and fill out diary cards; 4) Have not received pneumococcal vaccine or pertussis vaccine, and have no history of receiving other live vaccines in the past 14 days or non live vaccines in the past 7 days; 5) Underarm temperature ≤ 37.0 ℃.
排除标准
- •A history of invasive diseases caused by Streptococcus pneumoniae that has been confirmed through cultivation;
- •Known to be allergic to any component of the experimental vaccine, especially those allergic to diphtheria toxoid, or those who previously have a fever of 39.5 ℃ or above after receiving vaccine;
- •History or family history of seizures, epilepsy, encephalopathy, and mental illness;
- •Infants born with abnormal labor processes (difficult labor, instrumental delivery) or with a history of asphyxia or neurological organ damage;
- •A history of confirmed thrombocytopenia or other coagulation disorders may result in contraindications for subcutaneous injection;
- •Injecting human normal immunoglobulin after birth;
- •Known or suspected immunological dysfunction, receiving immunosuppressive therapy (radiation therapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), such as continuous treatment with systemic corticosteroids (prednisone or similar drugs) for ≥ 14 days, human immunodeficiency virus (HIV) infection, etc;
- •Having congenital malformations, severe malnutrition, developmental disorders, and genetic defects (such as favism);
- •Currently suffering from serious chronic diseases, infectious diseases, active infections, liver diseases, kidney diseases, cardiovascular diseases, and malignant tumors;
- •Severe asthma;
- •Systemic rash, skin ringworm, skin suppuration or blisters;
- •Currently or planning to participate in clinical trials of other drugs in the near future; Researchers believe that any situation that may affect the evaluation of the study.
研究组 & 干预措施
P+DTP group
Experimental
370 infants aged 3 months were enrolled in this group.
干预措施: 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) (Biological)
P-DTP group
Experimental
370 infants aged 3 months were enrolled in this group.
干预措施: Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) (Biological)
DTP group
Active Comparator
370 infants aged 3 months were enrolled in this group.
干预措施: 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) (Biological)
结局指标
主要结局
Antibody positive conversion rate
时间窗: 30 days after full vaccination
The positive conversion rates of diphtheria antibody (anti-D), tetanus antibody (anti-T), pertussis toxin antibody (anti-PT), and pertussis filamentous hemagglutinin antibody (anti-FHA) in P+DTP, P-DTP, and DTP groups，respectively.
次要结局
- Solicited AEs within 0-7 days after vaccination(0-7 days after vaccination)
- AEs within 0-30 minutes after vaccination(0-30 minutes after vaccination)
- Unsolicited AEs within 0-30 days after vaccination(0-30 days after vaccination)
- SAE within 0-6 months after primary immunization(0-6 months after primary immunization)
- Positive rate of IgG antibodies(30 days after full vaccination)
- GMC of IgG antibody(30 days after full vaccination)
研究者
研究点 (1)
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