Multiple Centers, Randomized, and Control Trail on the Immunogenicity and Safety of the Simultaneously Vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and Seasonal Influenza Vaccine(SIV)

Zhejiang Provincial Center for Disease Control and Prevention1 site in 1 country1,134 target enrollmentSeptember 16, 2019

ConditionsSeasonal Influenza Hand, Foot and Mouth Disease

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Seasonal Influenza
Sponsor: Zhejiang Provincial Center for Disease Control and Prevention
Enrollment: 1134
Locations: 1
Primary Endpoint: immunogenicity evaluation
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 The safety for each antigen when EV71 is administrated with SIV

Registry

clinicaltrials.gov

Start Date

September 16, 2019

End Date

November 30, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zhejiang Provincial Center for Disease Control and Prevention

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.