The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Seasonal Influenza, Hand, Foot and Mouth Disease

Intervention / Treatment
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* Biological: EV71 +SIV
* Biological: EV71
* Biological: SIV


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 11 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 EV71 +SIV<br>Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV) simultaneously with 28 days apart | Biological: EV71 +SIV<br>* Give 2 doses of EV71 +SIV, get 2 blood samples before the first dose and 28-43 days after the last dose.<br>|
| Active Comparator: Group 2 EV71<br>Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) with 28 days apart | Biological: EV71<br>* Give 2 doses of EV71 , get 2 blood samples before the first dose and 28-43 days after the last<br>|
| Active Comparator: Group 3 SIV<br>Give 2 doses of seasonal influenza vaccine(SIV) simultaneously with 28 days apart | Biological: SIV<br>* Give 2 doses of SIV , get 2 blood samples before the first dose and 28-43 days after the last<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunogenicity evaluation | The positive rate of antibody | change from baseline antibody concentration at 28 days after the last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety evaluation: The occurrence of adverse events | The occurrence of adverse events | up to 30 days after every injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunogenicity, Safety, Enterovirus 71 Vaccine, seasonal influenza vaccine