Status:
COMPLETED
The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine
Lead Sponsor:
Zhejiang Provincial Center for Disease Control and Prevention
Collaborating Sponsors:
China National Biotec Group Company Limited
Conditions:
Seasonal Influenza
Hand, Foot and Mouth Disease
Eligibility:
All Genders
6-11 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the Immunogenicity and safety of the simultaneously vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV)
Detailed Description
Main subjects: The seroconversion rate for each antigen when EV71 is administrated with SIV Secondary subjects: The positive rate of antibody for each antigen when EV71 is administrated with SIV Th...
Eligibility Criteria
Inclusion
- Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.
- Participant is aged ≥ 6 month to \<12 months.
- Participant without preventive inoculation of Enterovirus 71 Vaccine ,seasonal influenza vaccine vaccine and previous history of Enterovirus.
- Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
- Body temperature ≤ 37.0#.
Exclusion
- Known allergy to any constituent of the vaccine.
- Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.
- Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
- Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction.
- Known bleeding disorder.
- Receipt of the whole blood, blood plasma or immunoglobulin before the trial vaccination.
- Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination.
- An acute illness with or without fever (temperature ≥ 38.0#) in the 3 days preceding enrollment in the trial.
- Participation in any other intervention clinical trial.
- Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.
Key Trial Info
Start Date :
September 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
1134 Patients enrolled
Trial Details
Trial ID
NCT04133584
Start Date
September 16 2019
End Date
November 30 2021
Last Update
July 13 2022
Active Locations (1)
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1
Liandu Center for Disease Control and Prevention
Lishui, Zhejiang, China