A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

• Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (Biological), also known as DTacP: Intramuscular injection
• Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed (Biological), also known as DTaP: Intramuscular injection
• Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine (Biological), also known as PENTAXIM: Intramuscular injection

Primary outcomes

• The seroconversion rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody [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.
• Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody [1 month after Dose 3]: As measured at the central laboratory
• Percentage of participants reporting local reactions [Day 7 post-each dose]: As elicited by investigational site staff
• Percentage of participants reporting systemic events [Day 7 post-each dose]: As elicited by investigational site staff
• Percentage of participants reporting adverse events [within 30 days post-each dose]: As elicited by investigational site staff

Secondary outcomes

• The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody [Day 30 post-dose 3]: Seropositivity is defined as post-3 dose antibody concentrations ≥ protective antibody concentration
• Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody [before dose 4 at 18 months old(booster)]: As measured at the central laboratory
• The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody [before dose 4 at 18 months old(booster)]: Seropositivity is defined as antibody concentrations ≥ protective antibody concentration
• 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)]: As measured at the central laboratory
• 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)]: eropositivity is defined as antibody concentrations ≥ protective antibody concentration

Other outcomes

• Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody [12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5]: As measured at the central laboratory
• The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody [12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5]: Seropositivity is defined as antibody concentrations ≥ protective antibody concentration

Sex: All, ages: 2 Months to 3 Months, accepts healthy volunteers

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

• Lili Huang, Principal investigator, Henan Province Center for Disease Control and Prevention