A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
NCT ID: NCT05091619
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
2898 participants
INTERVENTIONAL
2021-10-22
2027-09-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Intramuscular injection
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
Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed
Intramuscular injection
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
Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
Intramuscular injection
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
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Intramuscular injection
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
Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed
Intramuscular injection
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
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Intramuscular injection
C1
subjects aged 3 months receive 3 doses of lot-1 vaccines with a interval of 30 days for primary immunization
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Intramuscular injection
C2
subjects aged 3 months receive 3 doses of lot-2 vaccines with a interval of 30 days for primary immunization
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Intramuscular injection
C3
subjects aged 3 months receive 3 doses of lot-3 vaccines with a interval of 30 days for primary immunization
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Intramuscular injection
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
2 Months
3 Months
ALL
Yes
Sponsors
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Beijing Institute of Biological Products Co Ltd.
INDUSTRY
China National Biotec Group Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Lili Huang
Role: PRINCIPAL_INVESTIGATOR
Henan Province Center for Disease Control and Prevention
Locations
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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
Countries
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Other Identifiers
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2016L10765-2
Identifier Type: -
Identifier Source: org_study_id
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