NCT06857370进行中（未招募）3 期
Inter-lot Consistency Clinical Trial of Adsorbed Cell-free DTP (Three-component) Combined Vaccine
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 780
- 试验地点
- 1
- 主要终点
- Geometric Mean Concentration (GMC) of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine.
研究概览
简要总结
This is a randomized, blinded, peer-controlled study. There will be 3 treatment groups, screened subjects were randomized in a 1:1:1 ratio to receive three batches of the DTcP trial vaccine, and completed the primary immunization according to the procedure of one dose each at 2, 4, and 6 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
- 60 Days 至 89 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2 months of age (60~89 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 research protocol.
排除标准
- •First dose exclusion criteria
- •Persons who have received a vaccine containing the DPT classified vaccine;
- •Premature labor (delivery before 37th week of gestation), low birth weight 60 (birth weight <2500g);
- •Those with abnormal labor and delivery, history of asphyxia rescue, history of neurological damage;
- •Who have had one of the pertussis, diphtheria or tetanus diseases;
- •Who have had household contact with an individual diagnosed with pertussis, diphtheria, or tetanus disease in the past 30 days;
- •Have a history of allergy to vaccines or vaccine components and severe side reactions to vaccines, such as hives, dyspnea, angioneurotic edema, and other allergic reactions;
- •Persons with a history of seizures, convulsions, convulsions, or cerebral palsy; or a history or family history of psychiatric illness; or other progressive neurologic disorders;
- •Have been diagnosed with an immunodeficiency, Human Immunodeficiency Virus (HIV) infection, lymphoma, leukemia, Systemic Lupus Erythematosus (SLE), Juvenile Rheumatoid Arthritis ( Juvenile Rheumatoid Arthritis (JRA) or other autoimmune diseases;
- •Any condition resulting in absence of spleen, defective spleen function;
- •Known or suspected acute illness or severe chronic disease (including: severe respiratory disease, severe cardiovascular disease, liver or kidney disease, severe skin disease, malignancy, etc.); or in an acute exacerbation of a chronic disease;
- •Physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders;
- •Immunosuppressive or modifying agents, cytotoxic consecutive therapy for more than 10 days (except inhaled and topical steroids) within 2 months prior to receiving the test vaccine;
- •Received blood products (other than hepatitis B immune globulin) within 2 months prior to receiving the test vaccine;
- •Participated or planning to participate in any other drug or vaccine clinical study;
- •Has received an injectable live attenuated vaccine within 14 days or another vaccine within 7 days prior to receiving the test vaccine;
- •Axillary temperature >37.3°C prior to vaccination;
- •Any other factor that, in the investigator's judgment, makes the subject unsuitable for participation in a clinical trial.
- •Exclusion Criteria for Doses 2,3
- •Persons who have had a severe allergic reaction following a previous dose of vaccine;
- •Persons with serious adverse reactions causally related to the previous dose of vaccination;
- •Those with a newly identified or newly occurring condition after the first dose of vaccination that does not meet the inclusion criteria for the first dose or meets the exclusion criteria for the first dose, as determined by the investigator for continued participation in the study;
- •Other reasons for exclusion as determined by the investigator.
研究组 & 干预措施
Experimental vaccine group A, 2 months old
Experimental
3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4
干预措施: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 1) (Biological)
Experimental vaccine group B, 2 months old
Experimental
3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4
干预措施: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2) (Biological)
Experimental vaccine group C, 2 months old
Experimental
3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4
干预措施: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3) (Biological)
结局指标
主要结局
Geometric Mean Concentration (GMC) of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine.
时间窗: 30 days after vaccination
次要结局
- Seroconversion rate of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine.(30 days after vaccination)
- Seropositivity rate of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine(30 days after vaccination)
- Incidence of solicited adverse reactions for each vaccine dose in 2-month-old subjects.(Within 0-7 days)
- Incidence of unsolicited adverse reactions for each vaccine dose in 2-month-old subjects.(Within 0-30 days)
- Incidence of Serious Adverse Events (SAEs) in 2-month-old subjects.(From first vaccination to 30 days after the third dose)
研究者
研究点 (1)
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