Long-Term Immunogenicity Study of Inactivated EV71 Vaccine in Children

Enterovirus 71 Human Clinical Trial

Official title:

Long-Term Immunogenicity Study of Inactivated EV71 Vaccine Produced in Vero Cells With Adjuvant AlPO4 in Children: Extension Study of Protocol CT-EV-21

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04072276
• Other study ID #: FU-EV-21e
• Status: Completed
• Start date: August 15, 2019
• Est. completion date: December 11, 2021

Study information

• Verified date: September 2021
• Source: Medigen Vaccine Biologics Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: December 11, 2021
• Est. primary completion date: December 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Enterovirus 71 Human
• Enterovirus Infections

Intervention

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

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital, HsincChu	Hsinchu
Taiwan	Mackay Memorial Hospital, Taipei	Taipei
Taiwan	National Taiwan University Hosptial	Taipei
Taiwan	Chang Gung Memorial Hospital, LinKou	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Medigen Vaccine Biologics Corp.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 5 years after first dose of EV71 vaccination