CompletedPhase 2

A Clinical Study for Inactivated Vaccine Against EV71

Taiwan366 participantsStarted 2014-09

Plain-language summary

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

Who can participate

Age range2 Months – 12 Years

SexALL

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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

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.

What they're measuring

To evaluate overall safety of EV71 vaccine in children, throughout the study period

Timeframe: 2 years after study initiation

Trial details

NCT IDNCT02200237

SponsorMedigen Vaccine Biologics Corp.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-05

View on ClinicalTrials.gov More Enterovirus 71 Human trials