Enterovirus 71 HumanNCT04072276
Long-Term Immunogenicity Study of Inactivated EV71 Vaccine in Children
An observational study of Enterovirus 71 Human, run by Medigen Vaccine Biologics Corp. at 4 sites in Taiwan.
Trial summary
This study is designed to evaluate the long-term antibody titers of EV71 vaccine 4 and 5 years after first dose vaccination for subjects at the age of 2 to < 6 years , and 3 to 5 years after first dose vaccination for subjects at the age of 2 months to < 2 years Read more about this study
- Who is it for?
- Ages 2 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Enterovirus 71 Human
- What is being tested?
- EV71 vaccine
- Type of treatment
- Vaccines
- How many people
- 227 participants
- Where
- 4 sitesTaiwan
- Study dates
- 15 Aug 2019to 11 Dec 2021
- Phase
- Observational
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects who have completed participation in study CT-EV-21
Who may be able to join
- Subjects who have completed participation in study CT-EV-21 part 2b, 2c, and 2d, and have received protocol specified doses of EV71 vaccine or Placebo (total of 2 doses in part 2b, and 3 doses for part 2c and 2d).
- The subjects' guardians are able to understand and sign the informed consent form.
Who cannot join
- Subjects and/or guardians who refuse to comply with the study procedures
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Mackay Memorial Hospital, HsincChu
Hsinchu
Mackay Memorial Hospital, Taipei
Taipei
National Taiwan University Hosptial
Taipei
Chang Gung Memorial Hospital, LinKou
Taoyuan
About this study
Official title: Long-Term Immunogenicity Study of Inactivated EV71 Vaccine Produced in Vero Cells With Adjuvant AlPO4 in Children: Extension Study of Protocol CT-EV-21
This study is designed to evaluate the long-term antibody titers of EV71 vaccine 4 and 5 years after first dose vaccination for subjects at the age of 2 to < 6 years , and 3 to 5 years after first dose vaccination for subjects at the age of 2 months to < 2 years
Read the detailed description
This is an extension study of protocol CT-EV-21, to evaluate the long-term immunogenicity of EV71vaccine.
The first study visit will be approximately 3 or 4 years after the administration of first vaccination of EV71 vaccine or placebo in CT-EV-21 study; 4 years after the first vaccination for subjects 2 to < 6 years of age (2b), and 3 years after first dose for subjects 2 months to < 2 years of age (2c and 2d).
Subjects of 2b will remain in the study for approximately 12 months and will have 2 clinic visits; subjects of 2c and 2d will remain in the study for approximately 24 months and will have 3 clinic visits. Immunogenicity response against EV71 virus antigen at each visit will be assessed.
- Conditions
- Enterovirus 71 Human
- Being tested
- EV71 vaccine
- Keywords
- EV71 Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV71 vaccineBiological
EV71 vaccine with Adjuvant AlPO4 and the placebo (Adjuvant AlPO4 only) were randomly administrated to subject in CT-EV-21 study
| Study group | Role | What they receive |
|---|---|---|
| EV71 Vaccine with Adjuvant AlPO4 | EV71 Vaccine Produced in Vero Cells with Adjuvant AlPO4 Receives: Biological: EV71 vaccine | |
| Adjuvant AlPO4 | Placebo (Adjuvant AlPO4 only) Receives: Biological: EV71 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum neutralizing antibody titer
Geometric mean titer (GMT) of EV71 neutralizing antibody titers at 4 and 5 years after first dose of EV71 vaccination for subjects of 2b; and 3 to 5 years after first dose of EV71 vaccination for subjects of 2c and 2d.
Measured: Up to 5 years after first dose of EV71 vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start15 Aug 2019
- Primary completion11 Dec 2021
- Study completion11 Dec 2021
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 227 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., Ph.D., Principal investigator, National Taiwan University HospitalCheng-Hsun Chiu, M.D., Ph.D., Principal investigator, Chang Gang Memorial Hospital, LinKouChien-Yu Lin, M.D., Ph.D., Principal investigator, Mackay Memorial Hospital, HsinChuNan-Chang Chiu, M.D., Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072276
- Sponsor's protocol ID
- FU-EV-21e
- Status last verified
- Sep 2021
- First submitted
- 19 Aug 2019
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Immunogenicity Study of Inactivated EV71 Vaccine Produced in Vero Cells With Adjuvant AlPO4 in Children: Extension Study of Protocol CT-EV-21
- ClinicalTrials.gov ID
- NCT04072276
- Acronym / sponsor ID
- FU-EV-21e
- Conditions
- Enterovirus 71 Human
- Keywords
- EV71 Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Medigen Vaccine Biologics Corp.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 11 Dec 2021 (actual)
- Study completion
- 11 Dec 2021 (actual)
- First posted
- 28 Aug 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.
This study is designed to evaluate the long-term antibody titers of EV71 vaccine 4 and 5 years after first dose vaccination for subjects at the age of 2 to < 6 years , and 3 to 5 years after first dose vaccination for subjects at the age of 2 months to < 2 years
Detailed description
This is an extension study of protocol CT-EV-21, to evaluate the long-term immunogenicity of EV71vaccine.
The first study visit will be approximately 3 or 4 years after the administration of first vaccination of EV71 vaccine or placebo in CT-EV-21 study; 4 years after the first vaccination for subjects 2 to < 6 years of age (2b), and 3 years after first dose for subjects 2 months to < 2 years of age (2c and 2d).
Subjects of 2b will remain in the study for approximately 12 months and will have 2 clinic visits; subjects of 2c and 2d will remain in the study for approximately 24 months and will have 3 clinic visits. Immunogenicity response against EV71 virus antigen at each visit will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EV71 Vaccine with Adjuvant AlPO4 | – | Biological: EV71 vaccineEV71 Vaccine Produced in Vero Cells with Adjuvant AlPO4 |
| Adjuvant AlPO4 | – | Biological: EV71 vaccinePlacebo (Adjuvant AlPO4 only) |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects who have completed participation in study CT-EV-21
Key inclusion criteria (2 listed)
- Subjects who have completed participation in study CT-EV-21 part 2b, 2c, and 2d, and have received protocol specified doses of EV71 vaccine or Placebo (total of 2 doses in part 2b, and 3 doses for part 2c and 2d).
- The subjects' guardians are able to understand and sign the informed consent form.
Key exclusion criteria (1 listed)
- Subjects and/or guardians who refuse to comply with the study procedures
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 vaccineEV71 vaccine with Adjuvant AlPO4 and the placebo (Adjuvant AlPO4 only) were randomly administrated to subject in CT-EV-21 study | Biological | Adjuvant AlPO4, EV71 Vaccine with Adjuvant AlPO4 |
Primary outcome
Serum neutralizing antibody titer
Time frame: Up to 5 years after first dose of EV71 vaccination
Geometric mean titer (GMT) of EV71 neutralizing antibody titers at 4 and 5 years after first dose of EV71 vaccination for subjects of 2b; and 3 to 5 years after first dose of EV71 vaccination for subjects of 2c and 2d.
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 30 Sep 2022.
- Individual participant dataSharing planned: No
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., Ph.D. principal investigator
National Taiwan University Hospital
Cheng-Hsun Chiu, M.D., Ph.D. principal investigator
Chang Gang Memorial Hospital, LinKou
Chien-Yu Lin, M.D., Ph.D. principal investigator
Mackay Memorial Hospital, HsinChu
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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?
The sponsor lists 2 inclusion and 1 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 30 Sep 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Serum neutralizing antibody titer (time frame: Up to 5 years after first dose of EV71 vaccination). 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 30 Sep 2022.