DTaP: A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Intramuscular injection
Other Names:
|
| Active Comparator: 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 |
Biological: Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed
Intramuscular injection
Other Names:
|
| Active Comparator: 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 |
Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
Intramuscular injection
Other Names:
|
| Experimental: 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 |
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Intramuscular injection
Other Names:
|
| Active Comparator: 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 |
Biological: Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed
Intramuscular injection
Other Names:
|
| Experimental: 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 |
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Intramuscular injection
Other Names:
|
| Experimental: C1 subjects aged 3 months receive 3 doses of lot-1 vaccines with a interval of 30 days for primary immunization |
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Intramuscular injection
Other Names:
|
| Experimental: C2 subjects aged 3 months receive 3 doses of lot-2 vaccines with a interval of 30 days for primary immunization |
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Intramuscular injection
Other Names:
|
| Experimental: C3 subjects aged 3 months receive 3 doses of lot-3 vaccines with a interval of 30 days for primary immunization |
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Intramuscular injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Neihuang County Center for Disease Control and Prevention | Anyang | Henan | China | 456300 |
| 2 | Wen County Center for Disease Control and Prevention | Jiaozuo | Henan | China | 454850 |
| 3 | Wuyang County Center for Disease Control and Prevention | Luohe | Henan | China | 462400 |
| 4 | Yanjin County Center for Disease Control and Prevention | Xinxiang | Henan | China | 453200 |
Sponsors and Collaborators
- China National Biotec Group Company Limited
- Beijing Institute of Biological Products Co Ltd.
Investigators
- Principal Investigator: Shengli Xia, Henan Province Center for Disease Control and Prevention
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016L10765-2