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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
2,898
Intramuscular injection
Intramuscular injection
Neihuang County Center for Disease Control and Prevention
Anyang, Henan, China
Wen County Center for Disease Control and Prevention
Jiaozuo, Henan, China
Wuyang County Center for Disease Control and Prevention
Luohe, Henan, China
Yanjin County Center for Disease Control and Prevention
Xinxiang, Henan, China
The seroconversion rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
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.
Time frame: 1 month after Dose 3
Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
As measured at the central laboratory
Time frame: 1 month after Dose 3
Percentage of participants reporting local reactions
As elicited by investigational site staff
Time frame: Day 7 post-each dose
Percentage of participants reporting systemic events
As elicited by investigational site staff
Time frame: Day 7 post-each dose
Percentage of participants reporting adverse events
As elicited by investigational site staff
Time frame: within 30 days post-each dose
The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Seropositivity is defined as post-3 dose antibody concentrations ≥ protective antibody concentration
Time frame: Day 30 post-dose 3
Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
As measured at the central laboratory
Time frame: before 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
Seropositivity is defined as antibody concentrations ≥ protective antibody concentration
Time frame: before dose 4 at 18 months old(booster)
Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
As measured at the central laboratory
Time frame: 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
eropositivity is defined as antibody concentrations ≥ protective antibody concentration
Time frame: Day 30 post-dose 4 at 18 months old(booster)
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