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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Whooping Cough; Tetanus; Diphtheria
• Intervention / Treatment: Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed; Biological: Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed; Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine

• Study Type: Interventional
• Enrollment (Actual): 2898
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Lili Huang, BA; Phone Number: +8613643826177; Email: 13643826177@163.com

Study Locations

• China
  • Henan
    • Anyang, Henan, China, 456300
      • Neihuang County Center for Disease Control and Prevention
    • Jiaozuo, Henan, China, 454850
      • Wen County Center for Disease Control and Prevention
    • Luohe, Henan, China, 462400
      • Wuyang County Center for Disease Control and Prevention
    • Xinxiang, Henan, China, 453200
      • Yanjin County Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 3 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

9

Arms and Interventions

Participant Group / 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: DTacP
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: DTaP
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: PENTAXIM
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: DTacP
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: DTaP
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: DTacP
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: DTacP
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: DTacP
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: DTacP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	As measured at the central laboratory	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	Seropositivity is defined as antibody concentrations ≥ protective antibody concentration	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	As measured at the central laboratory	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	eropositivity is defined as antibody concentrations ≥ protective antibody concentration	Day 30 post-dose 4 at 18 months old(booster)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Seropositivity is defined as antibody concentrations ≥ protective antibody concentration	12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Beijing Institute of Biological Products Co Ltd.
• Investigators: Principal Investigator: Lili Huang, Henan Province Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Estimated): September 22, 2023
• Study Completion (Estimated): September 22, 2027

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neurologic Manifestations; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Neuromuscular Manifestations; Actinomycetales Infections; Clostridium Infections; Hypocalcemia; Calcium Metabolism Disorders; Corynebacterium Infections; Whooping Cough; Tetanus; Diphtheria; Tetany; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 2016L10765-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In order to maintain the rights of the subject, do not open the IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No