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

NCT05091619
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
2,898
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Lead sponsor
China National Biotec Group Company Limited
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Start date
2021-10-22
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Number of sites
4
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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.
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Acronym
DTaP
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Short title
A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-09-22
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First posted
2021-10-25
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Registry last updated
2025-09-15
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Primary completion date
2024-01-22
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Start date
2021-10-22
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Actual participants
2,898
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Participants
2,898
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
4
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
China National Biotec Group Company Limited
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05091619
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ClinicalTrials.gov ID
NCT05091619
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Triple masking
Masked roles
Participants, Investigators, Outcome assessors
Sources for study design
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  1. 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

    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

    Timeframe: 1 month after Dose 3

    As measured at the central laboratory

  3. Percentage of participants reporting local reactions

    Timeframe: Day 7 post-each dose

    As elicited by investigational site staff

  4. Percentage of participants reporting systemic events

    Timeframe: Day 7 post-each dose

    As elicited by investigational site staff

  5. Percentage of participants reporting adverse events

    Timeframe: within 30 days post-each dose

    As elicited by investigational site staff

  1. 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

    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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

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

    eropositivity is defined as antibody concentrations ≥ protective antibody concentration

Sources for outcomes
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Sex
All
Age groups
Children
Minimum age
2 Months
Maximum age
3 Months
Healthy volunteers
Yes

  • 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.

  • 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
Sources for eligibility
clinicaltrials.gov

  • Neihuang County Center for Disease Control and PreventionAnyang, China
  • Wen County Center for Disease Control and PreventionJiaozuo, China
  • Wuyang County Center for Disease Control and PreventionLuohe, China
  • Yanjin County Center for Disease Control and PreventionXinxiang, China
Sources for sites
clinicaltrials.gov

Related records

Drugs (3)

Collaborators (1)

Lead sponsors (1)

Conditions (3)