A Study to Evaluate the Safety and Immunogenicity 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

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-09-30

Brief Summary

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This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine at a 0.25ml or 0.5ml dose in health volunteers

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Detailed Description

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This is a phase I, prospective, randomized, open-label, two-center study. A total 60 healthy volunteers will be screened for baseline characteristic inclusion/exclusion criteria after providing a written informed consent. Eligible subjects will be recruited and equally randomized to either receive 2 doses of EV71 vaccine 0.25ml or 0.5ml. All subjects should be followed till Day 210.

Conditions

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Enterovirus Infection

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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EV 71 vaccine 5ug

EV71 Vaccine 5ug

Group Type ACTIVE_COMPARATOR

EV71 vaccine

Intervention Type BIOLOGICAL

Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.

EV 71 vaccine 10ug

EV71 vaccine 10ug

Group Type EXPERIMENTAL

EV71 vaccine

Intervention Type BIOLOGICAL

Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.

Interventions

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EV71 vaccine

Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.

Intervention Type BIOLOGICAL

Other Intervention Names

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EV71 vac

Eligibility Criteria

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Inclusion Criteria

* Subject who is free of obvious health problems
* Able and willing to comply with the study procedure adn give written informed consent

Exclusion Criteria

* Female who is pregnant/lactating or planning to be pregnant
* Body mass index(BMI) \> 35
* Oral temperature \> 37.5 Celsius at the time of planned vaccination
* Subject with any abnormal laboratory results at screening
* With a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis or acute gastrointestinal illness associated with enterovirus infection in the past 3 months
* Has been diagnosed with neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder
* With a history of hypersensitivity to vaccine or allergic disease
* Use of any investigational/non-registered product within 30 days prior to vaccination
* Use of immunoglobulins or any blood products within 3 months prior to vaccination
* Chronic administration of immunosuppressants or other immunomodulators within 5 months prior to vaccination

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes