A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
- Conditions
- DiphtheriaWhooping CoughTetanus
- Interventions
- Biological: Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, AdsorbedBiological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccineBiological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
- Registration Number
- NCT05091619
- Lead Sponsor
- China National Biotec Group Company Limited
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2898
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A2 Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed 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 A3 Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine 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 C3 Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed subjects aged 3 months receive 3 doses of lot-3 vaccines with a interval of 30 days for primary immunization C1 Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed subjects aged 3 months receive 3 doses of lot-1 vaccines with a interval of 30 days for primary immunization B1 Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed 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 A1 Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed 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 B2 Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed 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 B3 Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed 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 C2 Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed subjects aged 3 months receive 3 doses of lot-2 vaccines with a interval of 30 days for primary immunization
- Primary Outcome Measures
Name Time Method 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.
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
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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
Wen County Center for Disease Control and Prevention
🇨🇳Jiaozuo, Henan, China
Neihuang County Center for Disease Control and Prevention
🇨🇳Anyang, Henan, China
Wuyang County Center for Disease Control and Prevention
🇨🇳Luohe, Henan, China
Yanjin County Center for Disease Control and Prevention
🇨🇳Xinxiang, Henan, China