Back to resultsA Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTaP)
Primary Purpose
Whooping Cough, Diphtheria, Tetanus
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed
Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Whooping Cough
Eligibility 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
Sites / Locations
- Neihuang County Center for Disease Control and Prevention
- Wen County Center for Disease Control and Prevention
- Wuyang County Center for Disease Control and Prevention
- Yanjin County Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Active Comparator
Active Comparator
Experimental
Active Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
A1
A2
A3
B1
B2
B3
C1
C2
C3
Arm 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
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
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
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
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
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
subjects aged 3 months receive 3 doses of lot-1 vaccines with a interval of 30 days for primary immunization
subjects aged 3 months receive 3 doses of lot-2 vaccines with a interval of 30 days for primary immunization
subjects aged 3 months receive 3 doses of lot-3 vaccines with a interval of 30 days for primary immunization
Outcomes
Primary Outcome Measures
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.
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
Percentage of participants reporting local reactions
As elicited by investigational site staff
Percentage of participants reporting systemic events
As elicited by investigational site staff
Percentage of participants reporting adverse events
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
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
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
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
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
eropositivity is defined as antibody concentrations ≥ protective antibody concentration
Full Information
NCT ID
NCT05091619
First Posted
October 21, 2021
Last Updated
June 15, 2023
Sponsor
China National Biotec Group Company Limited
Collaborators
Beijing Institute of Biological Products Co Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05091619
Brief Title
A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Acronym
DTaP
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
September 22, 2023 (Anticipated)
Study Completion Date
September 22, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Biotec Group Company Limited
Collaborators
Beijing Institute of Biological Products Co Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whooping Cough, Diphtheria, Tetanus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2898 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A1
Arm Type
Experimental
Arm 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
Arm Title
A2
Arm Type
Active Comparator
Arm 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
Arm Title
A3
Arm Type
Active Comparator
Arm 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
Arm Title
B1
Arm Type
Experimental
Arm 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
Arm Title
B2
Arm Type
Active Comparator
Arm 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
Arm Title
B3
Arm Type
Experimental
Arm 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
Arm Title
C1
Arm Type
Experimental
Arm Description
subjects aged 3 months receive 3 doses of lot-1 vaccines with a interval of 30 days for primary immunization
Arm Title
C2
Arm Type
Experimental
Arm Description
subjects aged 3 months receive 3 doses of lot-2 vaccines with a interval of 30 days for primary immunization
Arm Title
C3
Arm Type
Experimental
Arm Description
subjects aged 3 months receive 3 doses of lot-3 vaccines with a interval of 30 days for primary immunization
Intervention Type
Biological
Intervention Name(s)
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Other Intervention Name(s)
DTacP
Intervention Description
Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed
Other Intervention Name(s)
DTaP
Intervention Description
Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
Other Intervention Name(s)
PENTAXIM
Intervention Description
Intramuscular injection
Primary Outcome Measure Information:
Title
The seroconversion rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Description
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.
Time Frame
1 month after Dose 3
Title
Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Description
As measured at the central laboratory
Time Frame
1 month after Dose 3
Title
Percentage of participants reporting local reactions
Description
As elicited by investigational site staff
Time Frame
Day 7 post-each dose
Title
Percentage of participants reporting systemic events
Description
As elicited by investigational site staff
Time Frame
Day 7 post-each dose
Title
Percentage of participants reporting adverse events
Description
As elicited by investigational site staff
Time Frame
within 30 days post-each dose
Secondary Outcome Measure Information:
Title
The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Description
Seropositivity is defined as post-3 dose antibody concentrations ≥ protective antibody concentration
Time Frame
Day 30 post-dose 3
Title
Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Description
As measured at the central laboratory
Time Frame
before dose 4 at 18 months old(booster)
Title
The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Description
Seropositivity is defined as antibody concentrations ≥ protective antibody concentration
Time Frame
before dose 4 at 18 months old(booster)
Title
Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Description
As measured at the central laboratory
Time Frame
Day 30 post-dose 4 at 18 months old(booster)
Title
The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Description
eropositivity is defined as antibody concentrations ≥ protective antibody concentration
Time Frame
Day 30 post-dose 4 at 18 months old(booster)
Other Pre-specified Outcome Measures:
Title
Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Description
As measured at the central laboratory
Time Frame
12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5
Title
The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Description
Seropositivity is defined as antibody concentrations ≥ protective antibody concentration
Time Frame
12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lili Huang
Organizational Affiliation
Henan Province Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neihuang County Center for Disease Control and Prevention
City
Anyang
State/Province
Henan
ZIP/Postal Code
456300
Country
China
Facility Name
Wen County Center for Disease Control and Prevention
City
Jiaozuo
State/Province
Henan
ZIP/Postal Code
454850
Country
China
Facility Name
Wuyang County Center for Disease Control and Prevention
City
Luohe
State/Province
Henan
ZIP/Postal Code
462400
Country
China
Facility Name
Yanjin County Center for Disease Control and Prevention
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453200
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
In order to maintain the rights of the subject, do not open the IPD
Learn more about this trial
A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
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