Enterovirus 71 InfectionPhase 3NCT03865238
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of an EV71 Vaccine
A Phase 3 study testing EV71vac in people with Enterovirus 71 Infection, run by Medigen Vaccine Biologics Corp. at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Enterovirus 71 Infection
- What is being tested?
- EV71vac
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,061 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 23 Apr 2019to 16 Apr 2021
- 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 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
- Has had previous known exposure to EV71 or has received EV71 vaccine.
- Has a history of herpangina or HFMD associated with enterovirus infection in the past 30 days before the date of the planned study drug vaccination.
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- Has been diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic, or renal disorder.
- Has a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Has used any investigational/non-registered product (including drug, vaccine, or invasive medical device) within 28 days before vaccination or plan to use during the study period.
- Has confirmed or suspected autoimmune disorder, or immunodeficiency.
- Administration of any licensed live attenuated vaccine within 14 days before or after each study vaccination (with the exceptions of live attenuated Rotavirus vaccine via oral route).
- Has used immunoglobulins or any blood products within 11 months before vaccination or plan to use during the whole study period.
- Has had immunosuppressants, cytotoxic drugs, corticosteroids (including prednisolone ≥ 0.5 mg/kg/day or equivalent), or immunomodulators taken for > 14 days within 6 months before first vaccination or plan to use before the last scheduled study visit. (Inhaled and topical steroids are allowed).
- Has any medical or psychiatric condition, that is a contraindication to protocol participation based on the judgment of the Investigator.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Taiwan5 sites
Mackay Memorial Hospital, HsincChu
Hsinchu
Taichung Veteran General Hospital
Taichung
Mackay Memorial Hospital, Taipei
Taipei
National Taiwan Univeristy Hospital
Taipei
Chang Gung Memorial Hospital, LinKou
Taoyuan
About this study
Official title: A Phase 3, Prospective, Randomized, Double-blind, Placebo-controlled, Multi-region Study to Evaluate the Efficacy, Safety, and Immunogenicity of Inactivated EV71 Vaccine Produced in Vero Cells With Adjuvant in Infants and Children
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.
- Conditions
- Enterovirus 71 Infection
- Being tested
- EV71vac, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV71vacBiological
Subjects are to receive a 0.5 mL IM injection of EV71vac. Study drug is administered on Day 1 and Day 57 of the study. Subjects 2 months to < 2 years of age will receive a booster vaccination on Day 366.
PlaceboBiological
Subjects are to receive a 0.5 mL IM injection of placebo. Study drug is administered on Day 1 and Day 57 of the study. Subjects 2 months to < 2 years of age will receive a booster vaccination on Day 366.
| Study group | Role | What they receive |
|---|---|---|
| EV71vac | Experimental | Not described Receives: Biological: EV71vac |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Laboratory Confirmed EV71-Associated Disease
The primary outcome is the number of Laboratory confirmed EV71-associated disease by viral isolation or CODEHOP assay.
Measured: Approximately 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start23 Apr 2019
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enterovirus 71 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 3,061 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medigen Vaccine Biologics Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li-Min Huang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865238
- Sponsor's protocol ID
- CT-EV-31
- Status last verified
- Jun 2021
- First submitted
- 20 Feb 2019
- Last updated
- 19 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nguyen TT, Chiu CH, Lin CY, Chiu NC, Chen PY, Le TTV, Le DN, Duong AH, Nguyen VL, Huynh TN, Truong HK, Phan TL, Nguyen TTT, Shih SR, Huang CG, Weng YJ, Hsieh EF, Chang S, Chen C, Tai IC, Huang LM. Efficacy, safety, and immunogenicity of an inactivated, adjuvanted enterovirus 71 vaccine in infants and children: a multiregion, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2022 Apr 30;399(10336):1708-1717. doi: 10.1016/S0140-6736(22)00313-0. Epub 2022 Apr 12.
PubMed 35427481
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Prospective, Randomized, Double-blind, Placebo-controlled, Multi-region Study to Evaluate the Efficacy, Safety, and Immunogenicity of Inactivated EV71 Vaccine Produced in Vero Cells With Adjuvant in Infants and Children
- ClinicalTrials.gov ID
- NCT03865238
- Acronym / sponsor ID
- CT-EV-31
- Conditions
- Enterovirus 71 Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,061 participants (actual)
- Lead sponsor
- Medigen Vaccine Biologics Corp.Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EV71vac | Experimental | Biological: EV71vac |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 2 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
- Has had previous known exposure to EV71 or has received EV71 vaccine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EV71vacSubjects are to receive a 0.5 mL IM injection of EV71vac. Study drug is administered on Day 1 and Day 57 of the study. Subjects 2 months to < 2 years of age will receive a booster vaccination on Day 366. | Biological | EV71vac |
| PlaceboSubjects are to receive a 0.5 mL IM injection of placebo. Study drug is administered on Day 1 and Day 57 of the study. Subjects 2 months to < 2 years of age will receive a booster vaccination on Day 366. | Biological | Placebo |
Primary outcome
Number of Laboratory Confirmed EV71-Associated Disease
Time frame: Approximately 14 months
The primary outcome is the number of Laboratory confirmed EV71-associated disease by viral isolation or CODEHOP assay.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Derived from this study: PubMed 35427481Nguyen TT, Chiu CH, Lin CY, Chiu NC, Chen PY, Le TTV, Le DN, Duong AH, Nguyen VL, Huynh TN, Truong HK, Phan TL, Nguyen TTT, Shih SR, Huang CG, Weng YJ, Hsieh EF, Chang S, Chen C, Tai IC, Huang LM. Efficacy, safety, and immunogenicity of an inactivated, adjuvanted enterovirus 71 vaccine in infants and children: a multiregion, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2022 Apr 30;399(10336):1708-1717. doi: 10.1016/S0140-6736(22)00313-0. Epub 2022 Apr 12.
Related trials for Enterovirus 71 Infection
Active, not recruitingPhase 3
A Study to Evaluate the Immunogenicity and Safety of an EV71 Vaccine (Envacgen®) in Children Aged 6 to <10 Years Compared to Children Aged 2 to <6 Years
Enterovirus 71 Inactivated Vaccine
Not yet recruiting
Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children
Hand, Foot, and Mouth Disease (HFMD), Enterovirus 71 Infection
Not yet recruitingPhase 3
Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
Hand, Foot, and Mouth Disease(HFMD), Herpangina
Enrolling by invitationObservational study
Study on the Persistence of Immunity Following EV71 Vaccination
Hand, Foot, and Mouth Disease, Hand, Foot, and Mouth Disease (HFMD)
RecruitingPhase 3
Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell)
Hand, Foot, and Mouth Disease（HFMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Min Huang, MD principal investigator
National Taiwan University Hospital
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EV71vac in people with Enterovirus 71 Infection, run by Medigen Vaccine Biologics Corp. at 6 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 2 inclusion and 14 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 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Number of Laboratory Confirmed EV71-Associated Disease (time frame: Approximately 14 months). 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 NCT03865238, 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 19 Apr 2022.