Long-Term Immunogenicity Study of Inactivated EV71 Vaccine in Children
1 other identifier
observational
227
1 country
4
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2019
CompletedFirst Submitted
Initial submission to the registry
August 19, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2021
CompletedSeptember 30, 2022
September 1, 2021
2.3 years
August 19, 2019
September 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 5 years after first dose of EV71 vaccination
Study Arms (2)
EV71 Vaccine with Adjuvant AlPO4
EV71 Vaccine Produced in Vero Cells with Adjuvant AlPO4
Adjuvant AlPO4
Placebo (Adjuvant AlPO4 only)
Interventions
EV71 vaccine with Adjuvant AlPO4 and the placebo (Adjuvant AlPO4 only) were randomly administrated to subject in CT-EV-21 study
Eligibility Criteria
Subjects who have completed participation in study CT-EV-21
You may qualify if:
- 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.
You may not qualify if:
- Subjects and/or guardians who refuse to comply with the study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Mackay Memorial Hospital, HsincChu
Hsinchu, Taiwan
Mackay Memorial Hospital, Taipei
Taipei, Taiwan
National Taiwan University Hosptial
Taipei, Taiwan
Chang Gung Memorial Hospital, LinKou
Taoyuan District, Taiwan
Biospecimen
Serum
Study Officials
- PRINCIPAL INVESTIGATOR
Li-Min Huang, M.D., Ph.D.
National Taiwan University Hospital
- 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 Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2019
First Posted
August 28, 2019
Study Start
August 15, 2019
Primary Completion
December 11, 2021
Study Completion
December 11, 2021
Last Updated
September 30, 2022
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share