- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04072276
Long-Term Immunogenicity Study of Inactivated EV71 Vaccine in Children
Long-Term Immunogenicity Study of Inactivated EV71 Vaccine Produced in Vero Cells With Adjuvant AlPO4 in Children: Extension Study of Protocol CT-EV-21
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hsinchu, Taiwan
- Mackay Memorial Hospital, HsincChu
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Taipei, Taiwan
- National Taiwan University Hosptial
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Taipei, Taiwan
- Mackay Memorial Hospital, Taipei
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Taoyuan, Taiwan
- Chang Gung Memorial Hospital, Linkou
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Subjects and/or guardians who refuse to comply with the study procedures
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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EV71 Vaccine with Adjuvant AlPO4
EV71 Vaccine Produced in Vero Cells with Adjuvant AlPO4
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EV71 vaccine with Adjuvant AlPO4 and the placebo (Adjuvant AlPO4 only) were randomly administrated to subject in CT-EV-21 study
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Adjuvant AlPO4
Placebo (Adjuvant AlPO4 only)
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EV71 vaccine with Adjuvant AlPO4 and the placebo (Adjuvant AlPO4 only) were randomly administrated to subject in CT-EV-21 study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum neutralizing antibody titer
Time Frame: Up to 5 years after first dose of EV71 vaccination
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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.
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Up to 5 years after first dose of EV71 vaccination
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cheng-Hsun Chiu, M.D., Ph.D., Chang Gang Memorial Hospital, LinKou
- Principal Investigator: Chien-Yu Lin, M.D., Ph.D., Mackay Memorial Hospital, HsinChu
- Principal Investigator: Nan-Chang Chiu, M.D., Mackay Memorial Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FU-EV-21e
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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