Clinical trial NCT05091619: A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Whooping Cough
Diphtheria
Tetanus
Lead sponsor: China National Biotec Group Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Beijing Institute of Biological Products Co Ltd.
First posted: 2021-10-25
Enrollment: 2898
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: The seroconversion rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
timeFrame: 1 month after Dose 3
measure: Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
timeFrame: 1 month after Dose 3
measure: Percentage of participants reporting local reactions
timeFrame: Day 7 post-each dose
measure: Percentage of participants reporting systemic events
timeFrame: Day 7 post-each dose
measure: Percentage of participants reporting adverse events
timeFrame: within 30 days post-each dose
Secondary outcomes:
measure: The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
timeFrame: Day 30 post-dose 3
measure: Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
timeFrame: before dose 4 at 18 months old(booster)
measure: The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
timeFrame: before dose 4 at 18 months old(booster)
measure: Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
timeFrame: Day 30 post-dose 4 at 18 months old(booster)
measure: The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
timeFrame: Day 30 post-dose 4 at 18 months old(booster)
Other outcomes:
measure: Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
timeFrame: 12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5
measure: The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
timeFrame: 12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5
Locations:
city: Anyang
country: China
facility: Neihuang County Center for Disease Control and Prevention
state: Henan
city: Jiaozuo
country: China
facility: Wen County Center for Disease Control and Prevention
state: Henan
city: Luohe
country: China
facility: Wuyang County Center for Disease Control and Prevention
state: Henan
city: Xinxiang
country: China
facility: Yanjin County Center for Disease Control and Prevention
state: Henan
Study officials:
affiliation: Henan Province Center for Disease Control and Prevention
name: Lili Huang
role: PRINCIPAL_INVESTIGATOR
References: