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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05091619
Other study ID # 2016L10765-2
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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