CompletedNot Applicable

An Extension Study of EV-BR1701 Part A1

Taiwan180 participantsStarted 2025-09-20

Plain-language summary

To determine the long-term immunogenicity more than 5 years after EnVAX-A71 vaccination in the pediatric population aged 2 months to \<6 years when first vaccinated.

Who can participate

Age range

86 Months – 14 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 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).
. The subject's guardian/legal representative is able and willing to comply with study procedures and provide signed informed consent.

Exclusion criteria

. History of bleeding disorder, hemostatic difficulties or significant bruising caused by phlebotomy since the last visit in EV-BR1701 main study.
. Having been vaccinated with any EV71 vaccine products.

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

The long-term immunogenicity of EnVAX-A71 on the seroconversion rate (SCR)

Timeframe: From Sep-2025 to Dec-2025

The long-term immunogenicity of EnVAX-A71 on SPR

Timeframe: From Sep-2025 to Dec-2025

The long-term immunogenicity of EnVAX-A71 on the geometric mean titer (GMT) and geometric mean titer ratio (GMTR) of EV71 neutralizing antibody (NTAb)

Timeframe: From Sep-2025 to Dec-2025

Trial details

NCT IDNCT07635966

SponsorEnimmune Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-12-27

View on ClinicalTrials.gov More Enterovirus Infections trials

Who can participate

Age range

86 Months – 14 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 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).
. The subject's guardian/legal representative is able and willing to comply with study procedures and provide signed informed consent.

Exclusion criteria

. History of bleeding disorder, hemostatic difficulties or significant bruising caused by phlebotomy since the last visit in EV-BR1701 main study.
. Having been vaccinated with any EV71 vaccine products.

What they're measuring

The long-term immunogenicity of EnVAX-A71 on the seroconversion rate (SCR)

Timeframe: From Sep-2025 to Dec-2025

The long-term immunogenicity of EnVAX-A71 on SPR

Timeframe: From Sep-2025 to Dec-2025

The long-term immunogenicity of EnVAX-A71 on the geometric mean titer (GMT) and geometric mean titer ratio (GMTR) of EV71 neutralizing antibody (NTAb)

Timeframe: From Sep-2025 to Dec-2025