Long-Term Immunogenicity Study of Inactivated EV71 Vaccine in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

227 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-15

Study Completion Date

2021-12-11

Brief Summary

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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

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Detailed Description

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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

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Enterovirus 71 Human

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EV71 Vaccine with Adjuvant AlPO4

EV71 Vaccine Produced in Vero Cells with Adjuvant AlPO4

EV71 vaccine

Intervention Type BIOLOGICAL

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

Adjuvant AlPO4

Placebo (Adjuvant AlPO4 only)

EV71 vaccine

Intervention Type BIOLOGICAL

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

Interventions

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EV71 vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.