Active, not recruiting
Phase 3
A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Condition(s) studied
Whooping CoughDiphtheriaTetanus
Investigational drug(s) / intervention(s)
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, AdsorbedDiphtheria,Tetanus and Acellular Pertussis Combined Vaccine, AdsorbedDiphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed: Intramuscular injection
Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed: Intramuscular injection
Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine: Intramuscular injection
Study 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.
Eligibility
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
Primary outcome measure(s)
- 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
Trial sites (4)
| Facility | City | Region | Status |
|---|
| Neihuang County Center for Disease Control and Prevention |
Anyang |
Henan |
|
| Wen County Center for Disease Control and Prevention |
Jiaozuo |
Henan |
|
| Wuyang County Center for Disease Control and Prevention |
Luohe |
Henan |
|
| Yanjin County Center for Disease Control and Prevention |
Xinxiang |
Henan |
|
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