Long-Term Immunogenicity Study of Inactivated EV71 Vaccine in Children

Completed

• Conditions: Enterovirus 71 Human
• Interventions: Biological: EV71 vaccine

• Registration Number: NCT04072276
• Lead Sponsor: Medigen Vaccine Biologics Corp.

Brief 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.

Study Timeline

• Study Start: 2019-08-15
• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-26
• Study First Posted: 2019-08-28
• Status Verified: 2021-09
• Primary Completion: 2021-12-11
• Study Completion: 2021-12-11
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adjuvant AlPO4	EV71 vaccine	Placebo (Adjuvant AlPO4 only)
EV71 Vaccine with Adjuvant AlPO4	EV71 vaccine	EV71 Vaccine Produced in Vero Cells with Adjuvant AlPO4

Primary Outcome Measures

Name	Time	Method
Serum neutralizing antibody titer	Up to 5 years after first dose of EV71 vaccination	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.

Trial Locations

Locations (4)

Chang Gung Memorial Hospital, LinKou; 🇨🇳 Taoyuan, Taiwan

Mackay Memorial Hospital, Taipei; 🇨🇳 Taipei, Taiwan

Mackay Memorial Hospital, HsincChu; 🇨🇳 Hsinchu, Taiwan

National Taiwan University Hosptial; 🇨🇳 Taipei, Taiwan