CompletedPhase 3

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of an EV71 Vaccine

Taiwan3,061 participantsStarted 2019-04-23

Plain-language summary

Subjects will receive the first IM injection of study vaccine on Day 1 and will receive a second dose 56 days later. A booster vaccine will be given 365 days after the first dose in subjects 2 months to \< 2 years of age. The last study visit is on Day 422 when subjects will be contacted via telephone / home visit system to assess for adverse events and concomitant medications.

Who can participate

Age range2 Months – 6 Years

SexALL

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Inclusion criteria

✓. Healthy children and infants aged from 2 months to less than 6 years as established by medical history and clinical examination.
✓. The subjects' parents/guardians are able to understand and sign the ICF.

Exclusion criteria

✕. Age \< 2 months or ≥ 6 years.
✕. For subjects \< 1 year, gestational age \< 34 weeks or birth weight \< 2200 grams.
✕. Has poor venous access (for subjects in sub-study only).
✕. Currently has a fever defined as ear/rectal temperature ≥ 38°C or axillary temperature ≥ 37.5 °C within 2 days before the time of planned vaccination.
✕. Has had previous known exposure to EV71 or has received EV71 vaccine.
✕. Has a history of herpangina or HFMD associated with enterovirus infection in the past 30 days before the date of the planned study drug vaccination.
✕. Has been diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic, or renal disorder.
✕. Has a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

What they're measuring

Number of Laboratory Confirmed EV71-Associated Disease

Timeframe: Approximately 14 months

Trial details

NCT IDNCT03865238

SponsorMedigen Vaccine Biologics Corp.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04-16

View on ClinicalTrials.gov More Enterovirus 71 Infection trials