Status:
COMPLETED
Evaluation of the Safety and Immunogenicity of Simultaneously Administration of sIPV and DTaP
Lead Sponsor:
China National Biotec Group Company Limited
Collaborating Sponsors:
Chengdu Institute of Biological Products Co.,Ltd.
Beijing Institute of Biological Products Co Ltd.
Conditions:
Vaccination
Eligibility:
All Genders
3-3 years
Phase:
PHASE4
Brief Summary
Subjects will be recruited and divided into 3 groups:(1)combined immunization of Sabin-IPV and DTaP, (2) Sabin-IPV only and (3) DTaP only. After finishing the two basic vaccine EPI procedures, the im...
Detailed Description
It is recommended by China Food and Drug Administration (CFDA) that studies on simultaneous immunization of Sabin-IPV and DTaP be implemented soon and the immunogenicity and safety studies should be c...
Eligibility Criteria
Inclusion
- subjects aged 3 months old at the date of recruitment;
- with informed consent signed by parent(s) or guardians;
- parent(s) or guardians are able to attend all planned clinical appointments and
- obey and follow all study instructions;
- subjects have not been vaccinated with IPV vaccine, OPV vaccine, DTP vaccine and related vaccines;
Exclusion
- subject who has a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathy and neurological illness;
- allergic to any ingredient of vaccine or with allergy history to any vaccine;
- subjects with immunodeficiency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
- administration of immunoglobulins within 30 days prior to this study;
- acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
- have a clearly diagnosed history of thrombocytopenia or other coagulopathy,
- may cause contraindications for subcutaneous injection;
- any serious chronic illness, acute infectious diseases, or respiratory diseases;
- severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
- any kind of infectious, purulent, or allergic skin diseases;
- any other factor that makes the investigator determines the subject is unsuitable for this study.
Key Trial Info
Start Date :
August 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2021
Estimated Enrollment :
702 Patients enrolled
Trial Details
Trial ID
NCT04054882
Start Date
August 16 2019
End Date
September 9 2021
Last Update
July 7 2022
Active Locations (1)
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1
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China, 210009