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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 227 (actual)
• Sponsor: Medigen Vaccine Biologics Corp. · Industry
• Sex: All
• Age: 2 Years – 9 Years
• Healthy volunteers: Accepted

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

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

Interventions

Type	Name	Description
BIOLOGICAL	EV71 vaccine	EV71 vaccine with Adjuvant AlPO4 and the placebo (Adjuvant AlPO4 only) were randomly administrated to subject in CT-EV-21 study

Timeline

• Start date: 2019-08-15
• Primary completion: 2021-12-11
• Completion: 2021-12-11
• First posted: 2019-08-28
• Last updated: 2022-09-30

Locations

4 sites across 1 country: Taiwan