A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Study to Evaluate the Safety and Immunogenicity of the Diphtheria, Tetanus and Three-components Acellular Pertussis Combined Vaccine, Adsorbed in Healthy Infants at the Age of 2 Months and 3 Months
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,898
- 试验地点
- 4
- 主要终点
- Percentage of participants reporting systemic events
研究概览
简要总结
The study will evaluate the safety, immunogenicity，immune persistence and lot-to-lot consistency of Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, (DTacP) including 2 parts:
PART 1 will evaluate the safety and immunogenicity of DTacP in health infants aged 2 months and 3 months compared with an adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine and Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine (PENTAXIM)，compare the safety and immunogenicity of DTacP with different immunization schedules, and observe the immune persistence.
PART 2 will evaluate the lot-to-lot consistency of DTacP in health infants aged 3 months with the 3-dose schedule of 3-4-5 month.
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
- Triple (Participant, 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
- •Healthy subjects aged 2months (60-89 days) and 3months (90-119 days) ；
- •Willing to provide proof of identity
- •Subjects aged 2 months have not been vaccinated with DTaP, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine;
- •Subjects of 3 months have not been inoculated with DTaP vaccine, and IPV (only group A3）；
- •Subjects'guardians or trustees are able to understand and sign the informed consent voluntarily, comply with the requirements of the clinical study plan.
排除标准
- •With temperature >37.0°C on axillary setting before vacciation;
- •With a medical history of diphtheria, pertussis or tetanus;
- •Had contact with individuals with confirmed pertussis, diphtheria and tetanus diseases in their families in the past 30 days;
- •Premature birth (delivery before the 37th week of pregnancy)or low birth weight (birth weight< <2500g);
- •History of dystocia, suffocation rescue, neurological damage;
- •With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- •History of epilepsy, convulsions or convulsions, or have a family history of mental illness;
- •History of abnormal blood coagulation (such as coagulation factor deficiency, coagulopathy);
- •Had received immune enhancement or inhibitor therapy (continuous oral or instillation for more than 14 days);
- •History of severe allergic reactions to vaccination, such as difficulty breathing, urticaria;
- •Any prior administration of blood products in last 3 month;
- •Any prior administration of attenuated live vaccine in last 14 days;
- •Any prior administration of subunit or inactivated vaccines in last 7 days;
- •Plans to participate in or is participating in any other drug clinical study;
- •Has any other factors judged by investigators that make them unfit to participate in the clinical trial
研究组 & 干预措施
A1
subjects aged 3 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old
干预措施: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (Biological)
A2
subjects aged 3 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old
干预措施: Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed (Biological)
A3
subjects aged 3 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old
干预措施: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine (Biological)
B1
subjects aged 2 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old
干预措施: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (Biological)
B2
subjects aged 2 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old
干预措施: Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed (Biological)
B3
subjects aged 2 months receive 3 doses of vaccines with a interval of 2 months for primary immunization, and a booster dose at 18 month old
干预措施: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (Biological)
C1
subjects aged 3 months receive 3 doses of lot-1 vaccines with a interval of 30 days for primary immunization
干预措施: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (Biological)
C2
subjects aged 3 months receive 3 doses of lot-2 vaccines with a interval of 30 days for primary immunization
干预措施: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (Biological)
C3
subjects aged 3 months receive 3 doses of lot-3 vaccines with a interval of 30 days for primary immunization
干预措施: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (Biological)
结局指标
主要结局
Percentage of participants reporting systemic events
时间窗: Day 7 post-each dose
As elicited by investigational site staff
Percentage of participants reporting local reactions
时间窗: Day 7 post-each dose
As elicited by investigational site staff
Percentage of participants reporting adverse events
时间窗: within 30 days post-each dose
As elicited by investigational site staff
Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
时间窗: 1 month after Dose 3
As measured at the central laboratory
The seroconversion rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
时间窗: 1 month after Dose 3
seroconversion is defined as post-third dose antibody concentrations ≥ protective antibody concentration if pre-vaccination concentration is \< protective antibody concentration, or ≥ 4 x protective antibody concentration if pre-vaccination concentrations ≥ protective antibody concentration.
次要结局
- Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody(Day 30 post-dose 4 at 18 months old(booster))
- The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody(Day 30 post-dose 4 at 18 months old(booster))