Status:
COMPLETED
Evaluation of the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine
Lead Sponsor:
China National Biotec Group Company Limited
Collaborating Sponsors:
Zhejiang Provincial Center for Disease Control and Prevention
Henan Center for Disease Control and Prevention
Conditions:
Enterovirus Infections
Influenza
Eligibility:
All Genders
6-11 years
Phase:
PHASE4
Brief Summary
Subjects will be recruited and divided into 3 groups: 1. Experimental Group (378 subjects): combined immunization of EV71 vaccine and influenza vaccine; 2. Control Group A (378 subjects): EV71 vaccin...
Detailed Description
To further evaluate the feasibility of simultaneously administration of EV71 vaccine and flu vaccine, we design this clinical trial to test its immunogenicity and safety. 1134 subjects aged from 6 to ...
Eligibility Criteria
Inclusion
- subjects aged from 6-11 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 comply with all study instructions;
- subjects not receive any vaccination within 14 days at the date of recruitment;
- subjects have not been vaccinated with EV71 vaccine, seasonal flu vaccine;
- subjects with no medical history of EV71 infection;
- axillary temperature ≤37.0℃
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 :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2021
Estimated Enrollment :
1134 Patients enrolled
Trial Details
Trial ID
NCT04091880
Start Date
September 26 2019
End Date
August 10 2021
Last Update
October 12 2022
Active Locations (1)
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1
Zhejiang provincial center for disease control and prevention
Hangzhou, Zhejiang, China, 310051