Status:
UNKNOWN
Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP
Lead Sponsor:
China National Biotec Group Company Limited
Collaborating Sponsors:
Wuhan 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
Eligible,healthy infants will be recruited and divided into 3 groups:(1)combined immunization of sIPV and DTaP group, (2) sIPV group and (3) DTaP group. After completing the two basic vaccine EPI proc...
Detailed Description
It is recommended by China Food and Drug Administration (CFDA) that studies on simultaneous immunization of Sabin-IPV and DTaP be carried out as soon as possible, and the immunogenicity and safety stu...
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, cerebropathia and neurological illness;
- allergic to any ingredient of vaccine or with allergy history to any vaccine;
- subjects with immunodeficency 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 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2020
Estimated Enrollment :
702 Patients enrolled
Trial Details
Trial ID
NCT04053010
Start Date
August 10 2019
End Date
May 30 2020
Last Update
August 12 2019
Active Locations (1)
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1
Shaanxi Provincial Center for Disease Control and Prevention
Xi'an, Shaanxi, China, 710054