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

  • STATUS
    Recruiting
  • End date
    Sep 22, 2027
  • participants needed
    2898
  • sponsor
    China National Biotec Group Company Limited
Updated on 5 November 2021
tdap
tetanus
dtap
conjugate vaccines
diphtheria
hib vaccine
pentaxim
conjugate vaccine
acellular pertussis vaccine
poliomyelitis
haemophilus
Accepts healthy volunteers

Summary

The study will evaluate the safety, immunogenicityimmune 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.

Details
Condition Diphtheria, Throat and Tonsil Infections, Upper respiratory infection, Pertussis, Tetanus, whooping cough, Pertussis (Whooping Cough)
Treatment Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine, Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed
Clinical Study IdentifierNCT05091619
SponsorChina National Biotec Group Company Limited
Last Modified on5 November 2021

Eligibility

Yes No Not Sure

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 >37.0C 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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