A Randomized, Blinded, Positive Vaccine-controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of DTcP in Infants and Children at 2 and 3 Months of Age
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,520
- 试验地点
- 1
- 主要终点
- Serum anti-Pertussis Toxoid(PT), Filamentous hemagglutmin(FHA), Pertactin(PRN), DT(Diphtheria Toxoid), TT(Tetanus Toxoid) antibody positive conversion rate,GMC 30 days after completion of basal immunization in subjects in the 3-month-old group
研究概览
简要总结
The combined pertussis, diphtheria and tetanus vaccine, the first vaccine to be included in the Expanded Programme of Immunization(EPI) of World Health Organization(WHO), has played an important role in the prevention and control of these three infectious diseases. The (diphtheria，tetanus and acellular pertussis combined vaccine，DTaP) vaccine was successfully developed in China in 1993, and its safety and serological effects were confirmed by the observation of human safety, with mild vaccination reactions and good immunization effects.The (Diphtheria-tetanus-component acellular pertussis vaccine, DTcP) vaccine is suitable for immunization against pertussis, diphtheria and tetanus infections in people between 2 and 24 months of age.
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
- 2 Months 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2 months of age (60~89 days), 3 months of age (90~119 days), willing to provide identification documents
- •The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and can comply with the requirements of the clinical study protocol
排除标准
- •Infants 2 months of age who have received a vaccine containing the components of diphtheria, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine
- •Infants 3 months of age who have received vaccines containing diphtheria, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine or group A, group C meningococcal conjugate vaccine
- •3-month-old infant vaccinated with IPV
- •Premature birth (delivery before the 37th week of gestation), low birth weight (birth weight <2500g) for 2-month-old (60-89 days) and 3-month-old (90-119 days) infants
- •History of abnormal labor, asphyxia, and neurological damage
- •Those who have suffered from pertussis, diphtheria or tetanus
- •Individuals who have had household contact with individuals with confirmed pertussis, diphtheria, or tetanus disease in the past 30 days
- •History of allergy to vaccines or vaccine components, severe side effects to vaccines such as allergy, urticaria, respiratory distress, angioneurotic edema
- •Those with a history of epilepsy, convulsions, convulsions, cerebral palsy, or a history of mental illness or family history; or other progressive neurological disorders
- •Have been diagnosed with a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune disease
- •Any condition resulting in absence of spleen, defective spleen function
- •Known or suspected acute disease or serious chronic disease (including: serious respiratory disease, serious cardiovascular disease, liver and kidney disease, serious skin disease, malignant tumor, etc.); or in the acute phase of chronic disease
- •Physician-diagnosed coagulation abnormalities (e.g., clotting factor deficiency, coagulopathy, platelet abnormalities) or significant bruising or clotting disorders
- •Have had immunosuppressive or modifying agents, cytotoxic continuous treatment for more than 10 days in the past 6 months (except inhaled and topical steroids)
- •Received blood products (except hepatitis B immunoglobulin) within 3 months prior to receiving the experimental vaccine
- •Received another investigational drug or investigational vaccine within 1 month prior to receiving the experimental vaccine
- •Plan to participate or are participating in any other drug clinical studies
- •Received a live attenuated vaccine within 14 days prior to receiving the experimental vaccine, or received another vaccine within 7 days
- •Those with fever before vaccination, axillary body temperature >37.0°C
- •Any other factors that, in the judgment of the investigator, make participation in the clinical trial inappropriate
- •1-20 articles for the first dose exclusion criteria
- •Those who had a severe allergic reaction after the previous dose of vaccine
- •Persons with serious adverse reactions causally related to the previous dose of vaccination
- •Newly discovered or newly occurred after the first vaccination that do not meet the first dose inclusion criteria or meet the first dose exclusion criteria will be determined by the investigator whether to continue to participate in the study
- •Other reasons for exclusion as perceived by the researcher
- •22-25 for the 2nd, 3rd, 4th agent exclusion criteria
研究组 & 干预措施
Experimental vaccine group A，3 months old
4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 1,2,15~21
干预措施: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP) (Biological)
Control vaccine group B，3 months old
4 doses of DTaP vaccine (0.5 ml) on Day 0 and Month 1,2,15~21
干预措施: Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，DTaP (Biological)
Control vaccine group C，3 months old
4 doses of DTaP-IPV-Hib vaccine (0.5 ml) on Day 0 and Month 1,2,15~21
干预措施: Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed）and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-Hib (Biological)
Experimental vaccine group D，2 months old
4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 1,2,16~22
干预措施: DTcP (Biological)
Control vaccine group E，2 months old
4 doses of DTaP-IPV-Hib vaccine (0.5 ml) on Day 0 and Month 1,2,16~22
干预措施: DTaP-IPV-Hib (Biological)
Experimental vaccine group F，2 months old
4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 2,4,16~22
干预措施: DTcP (Biological)
结局指标
主要结局
Serum anti-Pertussis Toxoid(PT), Filamentous hemagglutmin(FHA), Pertactin(PRN), DT(Diphtheria Toxoid), TT(Tetanus Toxoid) antibody positive conversion rate,GMC 30 days after completion of basal immunization in subjects in the 3-month-old group
时间窗: 30 days after completion of basal immunization
Serum anti-PT, FHA, PRN, DT, TT antibody positive conversion rate, Geometric Mean Concentration(GMC) 30 days after completion of basal immunization in subjects in the 2-month-old group
时间窗: 30 days after completion of basal immunization
Incidence of adverse reactions within 0-30 days after each dose of vaccination in subjects in the 2-month-old group
时间窗: Within 0-30 days after each dose of vaccination
Incidence of adverse reactions within 0-30 days after each dose of vaccination in subjects in the 3-month-old group
时间窗: Within 0-30 days after each dose of vaccination
次要结局
未报告次要终点