Can a vaccine shield children from severe hand, foot, and mouth disease?

NCT ID NCT07793175

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This trial tests an inactivated EV71 vaccine in healthy children aged 6 to 71 months. The vaccine targets enterovirus 71, a major cause of severe hand, foot, and mouth disease in the Asia-Pacific region. Each child receives two doses, 30 days apart. Researchers measure whether the vaccine triggers protective antibodies and monitor for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Inactivated Enterovirus Type 71 (EV71) vaccine
What this could lead to
If successful, this vaccine could help protect Vietnamese children against severe hand, foot, and mouth disease caused by EV71.
What could go wrong
This is a single-arm study without a comparison group, and it measures immune response rather than actual disease prevention. The vaccine may not produce the same results in Vietnamese children as it did in Chinese trials.
Why investors are watching

Sinovac is testing its inactivated EV71 vaccine in 320 healthy Vietnamese children aged 6 to 71 months. The trial measures whether the vaccine triggers a protective antibody response and checks for side effects over two months. For a small-cap company, this readout matters because it could extend the vaccine's market beyond China into Vietnam, where hand, foot, and mouth disease is a serious threat.

If it works: A positive result could support regulatory approval in Vietnam, opening a new revenue stream for Sinovac. It would also strengthen the vaccine's track record in a second Asian population, which may help future regional partnerships.

If it fails: If the vaccine fails to show adequate immunogenicity or raises safety concerns, Sinovac would lose the Vietnam opportunity and face reputational damage. Trials often fail, and a delay in enrollment or data readout could also stall the company's plans.

AI-written from the trial record. Speculative, and not investment advice.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

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.

Ages

6 to 71 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Healthy children aged 6\~71 months when receiving the first dose of investigational EV71 vaccine; * Participants' legal guardians are able to understand and sign the informed consent voluntarily; * Participants are able to comply with the study procedures based on the assessment of the investigator; * Participants should provide verifiable identification, be reachable by the investigator and must be able to contact the investigator throughout the study period. Exclusion Criteria: * Prior history of hand, foot and mouth disease (HFMD); * Have been exposed to a case with laboratory-confirmed (virological diagnosis, e.g., via PCR or virus isolation) HFMD at home, day care, or other settings within 2 weeks before enrollment; * Prior participated in clinical trial of EV71 vaccine and received any investigational EV71 vaccine; * Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema; * Any known or history of autoimmune diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, etc.) or immunodeficiency/immunosuppression (such as HIV infection, organ transplantation), asplenia; * Received immunosuppressive for ≥14 days (e.g., prednisone equivalent of ≥2 mg/kg), or cytotoxic drug before enrollment, or plans to receive these treatments during the study participation. * Receipt of blood products or immunoglobulins within the past 3 months before enrollment in this study, or scheduled to receive these treatments during the study period; * Receipt of other investigational vaccines within 30 days prior to vaccination in this study; * Receipt of other vaccines within 14 days prior to vaccination in this study; * Presence of any acute disease (moderate to severe illness, with or without fever) or an acute exacerbation of a chronic condition within the 7 days prior to vaccination in this study. * Has fever on the day of vaccination, with the axillary temperature ≥ 37.5 celsius before vaccination; * Is participating in or planning to participate in other vaccine or drug clinical trials; * According to the investigator's judgment, the participant has any other factors that might interfere with the clinical trial results or pose additional risk to the participant due to participation in the study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Enterovirus 71 infection are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Pasteur Institute

    Ho Chi Minh City, Vietnam

More trials for these conditions

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