Phase IV Clinical Trial, Immunogenicity and Safety of EV71 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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-16

Study Completion Date

2017-09-15

Brief Summary

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The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different time after vaccination

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Detailed Description

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This study is an open-labelled, single-centered, stratified-randomized, phase IV clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine (developed by Sinovac Biotech Co., Ltd.) in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different times after vaccination. The enrolled subjects in this study receive two doses of EV71 vaccine with 1-month interval between doses. To evaluate safety of the vaccine, subjects will be observed for 30 days after the injection for the potential adverse events. To evaluate the immunogenicity of the vaccine, venous blood will be collected for the neutralizing antibody detection prior to vaccination, 10/20/30 days after the 1st dose and 30 days after the 2nd dose vaccination. All subjects will receive blood sampling for three times. Subjects will be randomly assigned to receive blood sampling at 10/20/30 days after 1st dose injection, with a ratio of 1: 1: 1.

Conditions

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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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EV71 vaccine & blood sampling (0, 10,60)

This group receive two doses injection of EV71 vaccine (0, 28 days), and three times of blood sampling on day of 0, 10, and 60 respectively for EV71 neutralizing antibody detection.

Group Type EXPERIMENTAL

EV71 vaccine

Intervention Type BIOLOGICAL

Two doses vaccination of EV71vaccine (Intramuscular injection, 0.5ml) with a schedule of 0, 28 days.

EV71 vaccine & blood sampling (0, 20,60)

This group receive two doses injection of EV71 vaccine (0, 28 days), and three times of blood sampling on day of 0, 20, and 60 respectively for EV71 neutralizing antibody detection.

Group Type EXPERIMENTAL

EV71 vaccine

Intervention Type BIOLOGICAL

Two doses vaccination of EV71vaccine (Intramuscular injection, 0.5ml) with a schedule of 0, 28 days.

EV71 vaccine& blood sampling (0, 30, 60)

This group receive two doses injection of EV71 vaccine (0, 28 days), and three times of blood sampling on day of 0, 30, and 60 respectively for EV71 neutralizing antibody detection.

Group Type EXPERIMENTAL

EV71 vaccine

Intervention Type BIOLOGICAL

Two doses vaccination of EV71vaccine (Intramuscular injection, 0.5ml) with a schedule of 0, 28 days.

Interventions

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EV71 vaccine

Two doses vaccination of EV71vaccine (Intramuscular injection, 0.5ml) with a schedule of 0, 28 days.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers aged 6-35 months old
* Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study
* Proven legal identity

Exclusion Criteria

For subjects with any of the following conditions, vaccination should not be administrated:

* History of hand foot and mouth disease
* Allergy to gentamicin; history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, pain, etc
* Severe chronic diseases
* Thrombocytopenia or hemorrhagic disease
* Immunodeficiency disease or receipt of immunosuppressant treatment
* Uncontrolled epilepsy or progressive neurological disorders(e.g. Guillain-Barre syndrome)
* Acute disease or acute stage of chronic disease prior to the study entry
* History of thyroidectomy, thyroid disease within 12 months prior to the study entry
* Asplenia or functional asplenia
* Axillary temperature \>37.0 ℃
* Any other factor that suggesting the volunteer is unsuitable for this study based on the judgment of investigators

* Subjects with any of the following conditions are forbidden to continue the 2nd dose of vaccination:

1. Any serious adverse event that has a causal relationship with the investigated vaccine
2. Severe allergic reactions or hypersensitivity after vaccination (including urticaria / rash appear within 30 minutes after vaccination
3. Any confirmed or suspected autoimmune disease or immunodeficiency disease (e.g., HIV infection)
4. Other reactions (including severe pain, severe swelling, severe activity limitation, persistent hyperthermia, severe headache or other systemic or local reactions)determined by the investigators
* For subjects suffering from acute disease or acute stage of chronic disease , whether to continue vaccination depends on themselves
* Subjects with the following conditions may receive vaccination in delayed time or withdraw from the study depending on the judgment of investigator

1. Acute disease (moderate or severe disease with or without fever) in case of vaccination
2. Axillary temperature \> 37.0 °C

Minimum Eligible Age

6 Months

Maximum Eligible Age

35 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes