Long-Term Immunogenicity Study of Inactivated EV71 Vaccine in Children

Medigen Vaccine Biologics Corp.227 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

227

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-21 study

Eligibility

Sex: ALLMin age: 2 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * Subjects and/or guardians who refuse to comply with the study procedures

Locations (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

Outcomes

Primary Outcomes

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.

Time frame: Up to 5 years after first dose of EV71 vaccination

Data from ClinicalTrials.gov

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