CompletedNot Applicable

A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine

China10,077 participantsStarted 2013-03

Plain-language summary

The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.

Who can participate

Age range6 Months – 35 Months

SexALL

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Inclusion Criteria: * All subjects vaccinated at least one injection of EV71 vaccine or the placebo in the phase III efficacy trial. Exclusion Criteria: * subjects who refuse to continue in the study.

What they're measuring

The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination

Timeframe: Within the second year after the second vaccination

Trial details

NCT IDNCT02001233

SponsorSinovac Biotech Co., Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-03

View on ClinicalTrials.gov More Hand, Foot and Mouth Disease trials