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

Tetanus Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05091619
• Other study ID #: 2016L10765-2
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 22, 2021
• Est. completion date: September 22, 2027

Study information

• Verified date: June 2023
• Source: China National Biotec Group Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2898
• Est. completion date: September 22, 2027
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Diphtheria
• Tetanus
• Whooping Cough

Intervention

Biological:
• 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

Locations

Country	Name	City	State
China	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

Sponsors (2)

Lead Sponsor	Collaborator
China National Biotec Group Company Limited	Beijing Institute of Biological Products Co Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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
Primary	Percentage of participants reporting local reactions	As elicited by investigational site staff	Day 7 post-each dose
Primary	Percentage of participants reporting systemic events	As elicited by investigational site staff	Day 7 post-each dose
Primary	Percentage of participants reporting adverse events	As elicited by investigational site staff	within 30 days post-each dose
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)