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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-16

Study Completion Date

2021-11-30

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)

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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

Conditions

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Seasonal Influenza Hand, Foot and Mouth Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1 EV71 +SIV

Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV) simultaneously with 28 days apart

Group Type EXPERIMENTAL

EV71 +SIV

Intervention Type BIOLOGICAL

Give 2 doses of EV71 +SIV, get 2 blood samples before the first dose and 28-43 days after the last dose.

Group 2 EV71

Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) with 28 days apart

Group Type ACTIVE_COMPARATOR

EV71

Intervention Type BIOLOGICAL

Give 2 doses of EV71 , get 2 blood samples before the first dose and 28-43 days after the last

Group 3 SIV

Give 2 doses of seasonal influenza vaccine(SIV) simultaneously with 28 days apart

Group Type ACTIVE_COMPARATOR

SIV

Intervention Type BIOLOGICAL

Give 2 doses of SIV , get 2 blood samples before the first dose and 28-43 days after the last

Interventions

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EV71 +SIV

Give 2 doses of EV71 +SIV, get 2 blood samples before the first dose and 28-43 days after the last dose.

Intervention Type BIOLOGICAL

EV71

Give 2 doses of EV71 , get 2 blood samples before the first dose and 28-43 days after the last

Intervention Type BIOLOGICAL

SIV

Give 2 doses of SIV , get 2 blood samples before the first dose and 28-43 days after the last

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

11 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No