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

Phase 3

Active, not recruiting

• Conditions: Diphtheria; Whooping Cough; Tetanus

• Registration Number: NCT05091619
• Lead Sponsor: China National Biotec Group Company Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Study Start: 2021-10-22
• Study First Posted: 2021-10-25
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18
• Primary Completion: 2023-09-22
• Study Completion: 2027-09-22

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2898

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of participants reporting local reactions	Day 7 post-each dose	As elicited by investigational site staff
Percentage of participants reporting systemic events	Day 7 post-each dose	As elicited by investigational site staff
Percentage of participants reporting adverse events	within 30 days post-each dose	As elicited by investigational site staff
Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody	1 month after Dose 3	As measured at the central laboratory
The seroconversion rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody	1 month after Dose 3	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.

Secondary Outcome Measures

Name	Time	Method
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)	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	Day 30 post-dose 4 at 18 months old(booster)	eropositivity is defined as antibody concentrations ≥ protective antibody concentration

Trial Locations

Locations (4)

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, China