A Randomized,Blind, Positive-controlled Phase I Clinical Trial to Preliminary Evaluate the Safety of DTcP Vaccine in Healthy Children Aged Between 2 Months and 6 Years

CS-CTP-DTcP-Ⅰ

Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using of the vaccine targeted the three components, it greatly reduced incidence of the three kinds of diseases. The Purpose of this study is to preliminary evaluate the safety of DTcP compared to adsorbed diphtheria and tetanus combined vaccine （DT），Diphtheria-tetanus-acellular pertussis vaccine（DTaP） or PENTAXIM（DTaP-IPV-Hib） in participants.

2020-04-28

2021-10-27

2021-11-25

Completed

Early phase I

400

Inclusion Criteria: * Healthy subjects aged 2months、3months、18-24months and 4-6 years old; * Willing to provide proof of identity; * Able to understand and sign the informed consent by guardians or trustees; * Able and willing comply with the requirements of the protocol by guardians or trustees; * Subjects of 2 months age have not been vaccinated with diphtheria, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine; * Subjects of 3 months have not been inoculated with vaccines containing diphtheria, Hib, 13-valent pneumococcal polysaccharide conjugate vaccine and Meningococcal Group AC Bivalent Meningococcal Conjugate Vaccine;volunteers of 3 months (C3 group) have not been inoculated with vaccines containing IPV; * Subjects aged 18-24 months who had completed the immunization program of 3 doses of DTaP and had without the fourth DTaP vaccine ; * Subjects aged 4-6 years who have completed the immunization program of 4 doses of DTaP or similar vaccines containing DTP component, but who have not received DT vaccine; Exclusion Criteria: * Premature birth in infant under 1 year of age (delivery before the 37th week of pregnancy)or low birth weight (birth weight\< 2300g for girls,\<2500g for boys); * History of abnormal labor process or asphyxia rescue ; * Subjects who has a medical history of diphtheria, pertussis or tetanus; * In the past 30 days, individuals who have had contact with individuals with confirmed pertussis, diphtheria and tetanus diseases in their families; * Allergic person; * Any prior administration of blood products in last 3 month; * Any prior administration of other research medicines in last 1 month; * Plans to participate in or is participating in any other drug clinical study; * Any prior administration of attenuated live vaccine in last 14 days; * Any prior administration of subunit or inactivated vaccines in last 7 days; * Had fever before vaccination, Subjects with temperature \>37.0°C on axillary setting; * According to the investigator's judgment, the subjects have any other factors that make them unfit to participate in the clinical trial

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 400, 'type': 'ACTUAL'}}

2022-10-31