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

China National Biotec Group (CNBG)

Status and phase: Active, not recruiting; Phase 3

Conditions: Diphtheria; Whooping Cough; Tetanus

Treatments: Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed; Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine; Biological: Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed

Study type: Interventional

Funder types: Industry

Identifiers

NCT05091619

2016L10765-2

Details and patient eligibility

About

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.

Enrollment: 2,898 patients

Sex: All

Ages: 2 to 3 months old

Volunteers: 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,898 participants in 9 patient groups

A1

Experimental group

Description:

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

Treatment:

Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

A2

Active Comparator group

Description:

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

Treatment:

Biological: Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed

A3

Active Comparator group

Description:

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

Treatment:

Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine

B1

Experimental group

Description:

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

Treatment:

Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

B2

Active Comparator group

Description:

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

Treatment:

Biological: Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed

B3

Experimental group

Description:

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

Treatment:

Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

C1

Experimental group

Description:

subjects aged 3 months receive 3 doses of lot-1 vaccines with a interval of 30 days for primary immunization

Treatment:

Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

C2

Experimental group

Description:

subjects aged 3 months receive 3 doses of lot-2 vaccines with a interval of 30 days for primary immunization

Treatment:

Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

C3

Experimental group

Description:

subjects aged 3 months receive 3 doses of lot-3 vaccines with a interval of 30 days for primary immunization

Treatment:

Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed