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Enterovirus InfectionsPhase 3NCT05099029

A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants and Children

A Phase 3 study testing EV71 vaccine in people with Enterovirus Infections, run by Enimmune Corporation at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objectives of this study are to evaluate the EV71vaccine efficacy, immune response and safety profiles after two injections of the cell culture-based inactivated EV71 vaccine with adjuvant Al(OH)3 administrated in pediatric population aged 2 months to 6 years old. Read more about this study

Who is it for?
Ages 2 to 71 monthsHealthy volunteers can take part
Conditions the study is for
Enterovirus Infections
What is being tested?
EV71 vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,982 participants
Where
9 sitesin 2 countries
Study dates
27 Jun 2018to 31 Jul 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 71 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy children aged from 2 months to 6 years old (i.e. >= 2 months old and < 7 years old) at the time of first vaccination.
  • Subject's guardians are able and willing to comply with study procedures and provide the signed informed consent.
  • Subject is able and can comply with the requirements of the protocol.
  • Subject with body temperature <= 38℃.

Who cannot join

  • Subject with previous known Enterovirus 71 (EV71) infection or investigational EV71 vaccination.
  • Subject with a history of herpangina, hand-foot-mouth disease, and acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 30 days.
  • Subject with a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Subject under 2 years old with gestation <34weeks or a birth weight <2200g.
  • History of epilepsy, seizures or non-febrile convulsions that may affect subject participation in the study in the opinion of the investigator.
  • Severe malnutrition or dysgenopathy at the screening visit.
Show all 16Show fewer
  • Major congenital defects or serious chronic illness, including perinatal brain damage at the screening visit.
  • Subject diagnosed of having autoimmune disease (e.g., celiac disease, type I diabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile idiopathic arthritis (JIA), immune (or idiopathic) thrombocytopenia purpura) that may affect subject participation in the study in the opinion of the investigator.
  • Bleeding disorder diagnosed by a doctor or significant bruising or hemostatic difficulties with IM injections or blood draws.
  • Any acute febrile illness 3 days prior to administrating the first vaccination.
  • Use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during Visit 1 to Visit 4 (Day 0 to Day 196).
  • Administration of any vaccine within 14 days prior to each study vaccination.
  • Use of immunoglobulins or any blood products within 3 months prior to vaccination.
  • Chronic administration (defined as > 14 day of continuous use) of systemic immunosuppressants, other systemic immunomodulators, or systemic corticosteroids within 6 months prior to vaccination.
  • Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.
  • Subject with any confirmed or suspected immunodeficiency.

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Taiwan7 sites

  • Changhua Christian Hospital

    Changhua

  • National Taiwan University Hospital HsinChu Branch

    Hsinchu

  • China Medical University Hospital

    Taichung

  • Taichung Veterans General Hospital

    Taichung

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Linkou Chang Gung Memorial Hospital

    Taoyuan

Other trials in Taiwan

Vietnam2 sites

  • Nguyen Dinh Chieu Hospital

    An Hội, Vinh Long

  • Vinh Long City Health Center

    Long Châu, Vinh Long

Other trials in Vietnam

About this study

Official title: A Phase III, Multiple-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of an Adjuvanted, Inactivated Enterovirus 71 (EV71) Vaccine in Healthy Infants and Children

The objectives of this study are to evaluate the EV71vaccine efficacy, immune response and safety profiles after two injections of the cell culture-based inactivated EV71 vaccine with adjuvant Al(OH)3 administrated in pediatric population aged 2 months to 6 years old.

Read the detailed description

The clinical trial designed in this Study is a placebo-controlled, double-blinded Phase III and is aimed to evaluate the vaccine efficacy, safety, immunogenicity and immune persistence of cell culture-based inactivated EV71 vaccine in children age of 2 months to <6 years old. Two doses of Alum-adjuvanted 1.0 μg per dose of EV71 vaccine candidate will be administrated to subjects. The efficacy will be evaluated within a two year period after receiving 2-regimen vaccination by comparing the EV71-associated disease rates between the vaccine and placebo groups. Whereas, the immunogenicity will be assessed on Day 56 and Day 196, and the immune persistence will be evaluated on Day 392. Safety will be followed up to Day 392.

Being tested
EV71 vaccine, Placebo
Keywords
Foot-and-Mouth Disease, Vaccines, Hand, foot and mouth Disease, EV71 vaccine
Medical subject headings
Enterovirus Infections, Foot-and-Mouth Disease, Hand, Foot and Mouth Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EV71 vaccineBiological

    EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose) Two vaccinations at 28 days apart

  • PlaceboBiological

    Placebo ([ adjuvant 150 μg AI(OH)3] per dose) Two vaccinations at 28 days apart

Study groups in NCT05099029
Study groupRoleWhat they receive
EV71 VaccineExperimentalNot described
Receives: Biological: EV71 vaccine
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence rate of Hand, Foot and Mouth disease caused by EV71 after the second vaccination.

    Evaluate the efficacy of EV71 vacccine against HFMD caused by EV71

    Measured: From 28 days after the second vaccination to two year

  2. Serum neutralizing antibody titers (NT) induced by the EV71 vaccine

    Evaluate the immunogenicity by the response rate

    Measured: 28 days after the second vaccination

Secondary outcomes (3)

  1. The incidence rate of the severe complications and hospitalization of EV71 associated HFMD/HA disease after the second vaccination.

    1. Evaluate the efficacy of vaccination against the severe complications, including neurologic, pulmonary edema, and cardiorespiratory failure, of EV71 associated HFMD/HA diseases after completion of full vaccination.
    2. Evaluate the efficacy of vaccination against the hospitalization of EV71 associated HFMD/HA diseases after completion of full vaccination.

    Measured: From 28 days after the second vaccination to two year

  2. Serum neutralizing antibody titers (NT) induced by the EV71 vaccine

    1. Evaluate the immunogenicity of EV71 vaccine with two-dose regimen.
    2. Evaluate the immune persistence of EV71 vaccine with two-dose regimen.
    3. Evaluate lot-to-lot consistency by comparing the immunogenicity induced by 3 independent EV71 vaccines.

    Measured: Day 0,56,196,and 392

  3. Adverse events of EV71 vaccine

    1. Occurrence and severity of solicited injection site relations and general reactions within 7 days following each injection.
    2. Occurrence and severity of unsolicited adverse events within 28 days following each injection.
    3. Occurrence and relations with vaccination of some special AE during the 6-months follow-up period (up to Day 196).
    4. Occurrence and relations with vaccination of serious adverse events (SAEs) during the one year follow-up period (up to Day 392).

    Measured: Day 0 to Day 392

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2021
  2. Study start27 Jun 2018
  3. Primary completion31 Jul 2024
  4. Study completion31 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,982 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05099029
Sponsor's protocol ID
EV-BR1701
Status last verified
Oct 2025
First submitted
18 Oct 2021
Last updated
11 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hwang KP, Luong QC, Huang YC, Lai CC, Le PH, Thi Tran MT, Tan BF, Chen PY, Yang SC, Liu WT, Thao NTT, Lee P, Lin ST, Liu CC, Chen CC, Yang CF, Huang LM. A randomised trial of a bioreactor-produced EV-A71 vaccine for endemic control in children. NPJ Vaccines. 2026 Feb 12;11(1):65. doi: 10.1038/s41541-026-01396-x.

    PubMed 41680199

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EV71 vaccine in people with Enterovirus Infections, run by Enimmune Corporation at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Taiwan, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence rate of Hand, Foot and Mouth disease caused by EV71 after the second vaccination. (time frame: From 28 days after the second vaccination to two year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05099029, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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