Status:
COMPLETED
Long-Term Immunogenicity Study of Inactivated EV71 Vaccine in Children
Lead Sponsor:
Medigen Vaccine Biologics Corp.
Conditions:
Enterovirus 71 Human
Eligibility:
All Genders
2-9 years
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 do...
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 va...
Eligibility Criteria
Inclusion
- 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
- Subjects and/or guardians who refuse to comply with the study procedures
Key Trial Info
Start Date :
August 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 11 2021
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT04072276
Start Date
August 15 2019
End Date
December 11 2021
Last Update
September 30 2022
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Mackay Memorial Hospital, HsincChu
Hsinchu, Taiwan
2
Mackay Memorial Hospital, Taipei
Taipei, Taiwan
3
National Taiwan University Hosptial
Taipei, Taiwan
4
Chang Gung Memorial Hospital, LinKou
Taoyuan District, Taiwan