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Vaccine shield lasts years in kids: new study confirms

NCT ID NCT07635966

Vaccine Sponsor: Enimmune Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well an inactivated EV71 vaccine protects children over 5 years after vaccination. It included 180 healthy kids who were first vaccinated between 2 months and 6 years old. Researchers measured antibody levels to see if protection lasted. The goal was to understand long-term immunity against enterovirus 71 infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

180 people

The number who actually took part.

Started

Sep 2025

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

EV-BR1701 was a randomized, multi-nation, multi-centered, double-blinded, phase III study to evaluate the efficacy and safety of an EV71 vaccine, EnVAX-A71, in healthy infants and children in Taiwan (Part A) and Vietnam (Part B). In both Parts, a sub-study for immunogenicity assessment for up to one year was performed. This extension study of EV-BR1701 aims to evaluate the long-term immunogenicity persistence more than 5 years after EnVAX-A71 vaccination in subjects originally participating in the immunogenicity sub-study in Taiwan.

Ages

86 months to 14 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy children who were enrolled in Part A1 (immunogenicity sub-study) of EV-BR1701, received two injections of either EnVAX-A71 or placebo, and had blood sample collected on Day 56 for primary immunogenicity endpoint analysis (the "evaluable" subjects). 2. The subject's guardian/legal representative is able and willing to comply with study procedures and provide signed informed consent. Exclusion Criteria: 1. History of bleeding disorder, hemostatic difficulties or significant bruising caused by phlebotomy since the last visit in EV-BR1701 main study. 2. Having been vaccinated with any EV71 vaccine products.

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Conditions

The condition(s) this trial relates to.

enterovirus infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Enterovirus infections

Contacts and locations

Locations

  • China Medical University Hospital

    Taichung, Taiwan

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, Taiwan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • National Taiwan University Hospital HsinChu Branch

    Hsinchu, Taiwan

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Other studies related to the condition(s) this trial covers.