A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
DTaP
A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Study to Evaluate the Safety and Immunogenicity of the Diphtheria, Tetanus and Three-components Acellular Pertussis Combined Vaccine, Adsorbed in Healthy Infants at the Age of 2 Months and 3 Months
1 other identifier
interventional
2,898
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2021
Longer than P75 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2021
CompletedStudy Start
First participant enrolled
October 22, 2021
CompletedFirst Posted
Study publicly available on registry
October 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2027
ExpectedSeptember 15, 2025
November 1, 2024
2.3 years
October 21, 2021
September 9, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
The seroconversion rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
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.
1 month after Dose 3
Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
As measured at the central laboratory
1 month after Dose 3
Percentage of participants reporting local reactions
As elicited by investigational site staff
Day 7 post-each dose
Percentage of participants reporting systemic events
As elicited by investigational site staff
Day 7 post-each dose
Percentage of participants reporting adverse events
As elicited by investigational site staff
within 30 days post-each dose
Secondary Outcomes (5)
The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Day 30 post-dose 3
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)
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)
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)
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)
Other Outcomes (2)
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
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
Study Arms (9)
A1
EXPERIMENTALsubjects 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
A2
ACTIVE COMPARATORsubjects 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
ACTIVE COMPARATORsubjects 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
B1
EXPERIMENTALsubjects 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
B2
ACTIVE COMPARATORsubjects 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
EXPERIMENTALsubjects 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
C1
EXPERIMENTALsubjects aged 3 months receive 3 doses of lot-1 vaccines with a interval of 30 days for primary immunization
C2
EXPERIMENTALsubjects aged 3 months receive 3 doses of lot-2 vaccines with a interval of 30 days for primary immunization
C3
EXPERIMENTALsubjects aged 3 months receive 3 doses of lot-3 vaccines with a interval of 30 days for primary immunization
Interventions
Intramuscular injection
Intramuscular injection
Intramuscular injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Neihuang County Center for Disease Control and Prevention
Anyang, Henan, 456300, China
Wen County Center for Disease Control and Prevention
Jiaozuo, Henan, 454850, China
Wuyang County Center for Disease Control and Prevention
Luohe, Henan, 462400, China
Yanjin County Center for Disease Control and Prevention
Xinxiang, Henan, 453200, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lili Huang
Henan Province Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2021
First Posted
October 25, 2021
Study Start
October 22, 2021
Primary Completion
January 22, 2024
Study Completion (Estimated)
September 22, 2027
Last Updated
September 15, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
In order to maintain the rights of the subject, do not open the IPD