Long-Term Immunogenicity Study of Inactivated EV71 Vaccine in Children

September 29, 2022 updated by: Medigen Vaccine Biologics Corp.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

227

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Hsinchu, Taiwan
        • Mackay Memorial Hospital, HsincChu
      • Taipei, Taiwan
        • National Taiwan University Hosptial
      • Taipei, Taiwan
        • Mackay Memorial Hospital, Taipei
      • Taoyuan, Taiwan
        • Chang Gung Memorial Hospital, Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 9 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who have completed participation in study CT-EV-21

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EV71 Vaccine with Adjuvant AlPO4
EV71 Vaccine Produced in Vero Cells with Adjuvant AlPO4
Biological: EV71 vaccine
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)
Biological: EV71 vaccine
EV71 vaccine with Adjuvant AlPO4 and the placebo (Adjuvant AlPO4 only) were randomly administrated to subject in CT-EV-21 study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum neutralizing antibody titer
Time Frame: 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.
Up to 5 years after first dose of EV71 vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medigen Vaccine Biologics Corp.

Investigators

  • Principal Investigator: Cheng-Hsun Chiu, M.D., Ph.D., Chang Gang Memorial Hospital, LinKou
  • Principal Investigator: Chien-Yu Lin, M.D., Ph.D., Mackay Memorial Hospital, HsinChu
  • Principal Investigator: Nan-Chang Chiu, M.D., Mackay Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 15, 2019

Primary Completion (ACTUAL)

December 11, 2021

Study Completion (ACTUAL)

December 11, 2021

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (ACTUAL)

August 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FU-EV-21e

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Enterovirus 71 Human

Clinical Trials on EV71 vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe