Enterovirus 71 HumanPhase 2EV71NCT02200237
A Clinical Study for Inactivated Vaccine Against EV71
A Phase 2 study testing EV71 with adjuvant aluminium phosphate in people with Enterovirus 71 Human, run by Medigen Vaccine Biologics Corp. at 4 sites in Taiwan.
Trial summary
This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to <12yrs. Read more about this study
- Who is it for?
- Ages 2 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Enterovirus 71 Human
- What is being tested?
- EV71 with adjuvant aluminium phosphate
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 4 sitesTaiwan
- Study dates
- Sep 2014to Aug 2017
- Phase
- Phase 2
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Main Inclusion Criteria:
- Healthy children and infants aged from 2 months to less than 12 years as established by medical history and clinical examination
- The subjects' guardians are able to understand and sign the informed consent
Main Exclusion Criteria:
- Subject with previous known exposure to EV71.
- Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.
- Subject who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder.
- Use of any investigational/non-registered product (including drug, vaccine and invasive medical device) within 30 days prior to vaccination or planned use during study period.
- Subject with any confirmed or suspected autoimmune disorder, or immunodeficiency
- Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Chang-Guang Memorial Hospital Lin-Kou
Taipei
Far Eastern Memorial Hospital
Taipei
MacKay Memorial Hospital
Taipei
National Taiwan University Hosptial
Taipei
About this study
This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to <12yrs.
- Conditions
- Enterovirus 71 Human
- Being tested
- EV71 with adjuvant aluminium phosphate, Placebo
- Keywords
- EV71 Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV71 with adjuvant aluminium phosphateBiological
Two arms, EV71 with aluminium phosphate
PlaceboBiological
Phosphate Buffer Saline with adjuvant aluminium phosphate
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Phosphate Buffer Saline with adjuvant aluminium phosphate Receives: Biological: Placebo |
| EV71 with adjuvant aluminium phosphate | Experimental | Inactive whole monovalent EV71 virion vaccine formulated with phosphate-buffered saline based adjuvanted aluminium phosphate 150 μg/0.5ml Receives: Biological: EV71 with adjuvant aluminium phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate overall safety of EV71 vaccine in children, throughout the study period
Occurrence of overall adverse events and serious adverse events during the entire period of study.
Measured: 2 years after study initiation
Secondary outcomes (1)
To evaluate immunogenicity, serum neutralizing antibody titers humoral immune response, induced by candidate vaccine
To evaluate the immunogencity in terms of
- Geometric mean titer (GMT) of EV71 neutralizing antibody titers
- Post-vaccination-to-pre-vaccination GMT ratio of EV 71 neutralizing antibody titers
- Seropositivity rate
Measured: 2 years from study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterovirus 71 HumanStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medigen Vaccine Biologics Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li-Min Huang, M.D., PhD., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200237
- Sponsor's protocol ID
- CT-EV-21
- Acronym
- EV71
- Status last verified
- Aug 2017
- First submitted
- 18 Jul 2014
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study for Inactivated Vaccine Against EV71
- ClinicalTrials.gov ID
- NCT02200237
- Acronym / sponsor ID
- EV71 / CT-EV-21
- Conditions
- Enterovirus 71 Human
- Keywords
- EV71 Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Medigen Vaccine Biologics Corp.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 25 Jul 2014 (estimated)
- 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.
This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to <12yrs.
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 |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboPhosphate Buffer Saline with adjuvant aluminium phosphate |
| EV71 with adjuvant aluminium phosphate | Experimental | Biological: EV71 with adjuvant aluminium phosphateInactive whole monovalent EV71 virion vaccine formulated with phosphate-buffered saline based adjuvanted aluminium phosphate 150 μg/0.5ml |
Who may qualify
- Ages
- 2 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| EV71 with adjuvant aluminium phosphateTwo arms, EV71 with aluminium phosphate | Biological | EV71 with adjuvant aluminium phosphate |
| PlaceboPhosphate Buffer Saline with adjuvant aluminium phosphate | Biological | Placebo |
Primary outcome
To evaluate overall safety of EV71 vaccine in children, throughout the study period
Time frame: 2 years after study initiation
Occurrence of overall adverse events and serious adverse events during the entire period of study.
1 secondary outcome
To evaluate immunogenicity, serum neutralizing antibody titers humoral immune response, induced by candidate vaccine
Time frame: 2 years from study initiation
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 18 Aug 2017.
Related trials for Enterovirus 71 Human
Enrolling by invitationObservational study
Study on the Persistence of Immunity Following EV71 Vaccination
Hand, Foot, and Mouth Disease, 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, M.D., PhD. principal investigator
National Taiwan University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EV71 with adjuvant aluminium phosphate in people with Enterovirus 71 Human, run by Medigen Vaccine Biologics Corp. at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate overall safety of EV71 vaccine in children, throughout the study period (time frame: 2 years after study initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2017.