Enterovirus 71 Human
Conditions
Keywords
EV71 vaccine, Envacgen®
Brief summary
This study is designed to evaluate the long-term antibody titers of Envacgen® approximately 6 years after the first vaccination dose in participants who were aged 2 months to \<6 years at the time of enrollment in the CT-EV-31s study.
Detailed description
This is an extension study of protocol CT-EV-31s, to evaluate the long-term immunogenicity of EV71 Enterovirus Vaccine (Envacgen®). The study will consist of a single visit approximately 6 years after the first vaccination of the EV71 vaccine or Placebo in participants aged 2 months to \< 6 years when participating in the CT-EV-31s study. Immunogenicity response against EV71 virus antigen at the visit will be assessed.
Interventions
BIOLOGICALEV71 vaccine
EV71 vaccine with Adjuvant AlPO4 and the placebo (Adjuvant AlPO4 only) were randomly administrated to subject in CT-EV-31s study
Sponsors
Medigen Vaccine Biologics Corp.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants who have completed participation in study CT-EV-31s and have received protocol specified doses of EV71 vaccine or Placebo. * The participant and/or participant's parent/guardian is able to understand and sign the informed consent form.
Exclusion criteria
* The participant and/or participant's parent/guardian refuse to comply with the study procedures. * After completing the CT-EV-31s trial, participants who received any EV71 vaccine before participating in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum neutralizing antibody titer | Approximately 6 years after first dose of vaccination. | Geometric mean titer (GMT) of EV71 neutralizing antibody at approximately 6 years after first dose of EV71 vaccination or Placebo for participants. |
| Seroprotection rate | Approximately 6 years after first dose of vaccination | Seroprotection rate (defined as neutralizing antibody titer ≥1:32) at approximately 6 years after first dose of EV71 vaccination or Placebo for participants. |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORLi-Min Huang, M.D., Ph.D.
National Taiwan University Hospital
PRINCIPAL_INVESTIGATORNan-Chang Chiu, M.D.
Mackay Memorial Hospital
PRINCIPAL_INVESTIGATORCheng-Hsun Chiu, M.D., Ph.D.
Chang Gang Memorial Hospital, LinKou
PRINCIPAL_INVESTIGATORChien-Yu Lin, M.D., Ph.D.
Mackay Memorial Hospital, HsinChu
Outcome results
None listed