A Clinical Study for Inactivated Vaccine Against EV71

Medigen Vaccine Biologics

Status and phase

Completed

Phase 2

Conditions

Enterovirus 71 Human

Treatments

Biological: Placebo

Biological: EV71 with adjuvant aluminium phosphate

Study type

Interventional

Funder types

Industry

Identifiers

NCT02200237

CT-EV-21

Details and patient eligibility

About

This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to <12yrs.

Enrollment

366 patients

Sex

All

Ages

2 months to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

Healthy children and infants aged from 2 months to less than 12 years as established by medical history and clinical examination
The subjects' guardians are able to understand and sign the informed consent

Main Exclusion Criteria:

Subject with previous known exposure to EV71.
Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.
Subject who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder.
Use of any investigational/non-registered product (including drug, vaccine and invasive medical device) within 30 days prior to vaccination or planned use during study period.
Subject with any confirmed or suspected autoimmune disorder, or immunodeficiency
Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.