CompletedPhase 3

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

Taiwan, Vietnam3,061 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 range

2 Months – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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