Last updated: November 16, 2020
Sponsor: China National Biotec Group Company Limited
Overall Status: Active - Recruiting
Phase
4
Condition
N/ATreatment
N/AClinical Study ID
NCT04636827
sIPV-DTaP-HepA-2020
Ages 18-19 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects must have participated the clinical trial titled "Clinic Trial to Evaluatethe Safety and Immunogenicity of Combined Immunization of sIPV and DTaP" (NCT04053010)in 2019, and have finished 3 doses of combined immunization of sIPV and DTaP;
- Subjects aged 18-19 months old at the date of recruitment;
- With informed consent form (ICF) signed by parent(s) or guardian(s);
- Parent(s) or guardian(s) are able to attend all planned clinical appointments andobey/follow all study instructions;
- Subjects have not been vaccinated with sIPV/DTaP/HepA at the age of 18-month-old yet;
- No less than 14 days since the last dose of vaccination;
- Axillary temperature ≤37.0℃.
Exclusion
Exclusion Criteria:
- With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia andneurological 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(Takingorally injecting of steroid hormone);
- Administration of immunoglobulins within 30 days prior to this study;
- Acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
- With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may causecontraindications for subcutaneous injection;
- With any serious chronic illness, acute infectious diseases, or respiratory diseases;
- With severe cardiovascular disease, liver and kidney diseases or diabetes mellituswith complications;
- With any kind of infectious, purulent, or allergic skin diseases;
- With any other factor that makes the investigator determines the subject is unsuitablefor this study.
Study Design
Total Participants: 600
Study Start date:
November 11, 2020
Estimated Completion Date:
December 31, 2021
Study Description
Connect with a study center
Hebei Provincial Center for Disease Control and Prevention
Shijia Zhuang, Hebei 050024
ChinaActive - Recruiting
Shaanxi Provincial Center for Disease Control and Prevention
Xi'an, Shaanxi 710054
ChinaActive - Recruiting
Shanxi Provincial Center for Disease Control and Prevention
Taiyuan, Shanxi 030012
ChinaActive - Recruiting
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