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NCT Number: NCT05091619

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

2 month–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neihuang County Center for Disease Control and Prevention, Anyang, Henan, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

Biological

Intramuscular injection

Other names: DTacP

Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed

Biological

Intramuscular injection

Other names: DTaP

Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine

Biological

Intramuscular injection

Other names: PENTAXIM

Primary outcomes

  1. The seroconversion rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody

    Time frame: 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.

  2. Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody

    Time frame: 1 month after Dose 3

    As measured at the central laboratory

  3. Percentage of participants reporting local reactions

    Time frame: Day 7 post-each dose

    As elicited by investigational site staff

  4. Percentage of participants reporting systemic events

    Time frame: Day 7 post-each dose

    As elicited by investigational site staff

  5. Percentage of participants reporting adverse events

    Time frame: within 30 days post-each dose

    As elicited by investigational site staff

Secondary outcomes

  1. The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody

    Time frame: Day 30 post-dose 3

    Seropositivity is defined as post-3 dose antibody concentrations ≥ protective antibody concentration

  2. Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody

    Time frame: before dose 4 at 18 months old(booster)

    As measured at the central laboratory

  3. The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody

    Time frame: before dose 4 at 18 months old(booster)

    Seropositivity is defined as antibody concentrations ≥ protective antibody concentration

  4. Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody

    Time frame: Day 30 post-dose 4 at 18 months old(booster)

    As measured at the central laboratory

  5. The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody

    Time frame: Day 30 post-dose 4 at 18 months old(booster)

    eropositivity is defined as antibody concentrations ≥ protective antibody concentration

Other outcomes

  1. Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody

    Time frame: 12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5

    As measured at the central laboratory

  2. The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody

    Time frame: 12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5

    Seropositivity is defined as antibody concentrations ≥ protective antibody concentration

Sponsors and collaborators

Lead sponsor

China National Biotec Group Company Limited

Industry

Collaborators

  • Beijing Institute of Biological Products Co Ltd.

Registry information

Official study 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

Acronym: DTaP

Important dates

Study start
2021
Primary completion
2024
Study completion
2027
First posted
Oct 25, 2021
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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