Long-Term Immunogenicity of Envacgen® in Children

N/AActive Not RecruitingNCT07568522

Medigen Vaccine Biologics Corp.220 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

220

Conditions

Enterovirus 71 Human

Interventions

EV71 vaccineBIOLOGICAL

EV71 vaccine with Adjuvant AlPO4 and the placebo (Adjuvant AlPO4 only) were randomly administrated to subject in CT-EV-31s study

Eligibility

Sex: ALLMin age: 6 YearsMax age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

Mackay Memorial Hospital, HsincChu

Hsinchu, Taiwan

Mackay Memorial Hospital, Taipei

Taipei, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Chang Gung Medical Hospital Linkou

Taoyuan, Taiwan

Outcomes

Primary Outcomes

Serum neutralizing antibody titer

Geometric mean titer (GMT) of EV71 neutralizing antibody at approximately 6 years after first dose of EV71 vaccination or Placebo for participants.

Time frame: Approximately 6 years after first dose of vaccination.

Seroprotection rate

Seroprotection rate (defined as neutralizing antibody titer ≥1:32) at approximately 6 years after first dose of EV71 vaccination or Placebo for participants.

Time frame: Approximately 6 years after first dose of vaccination

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.