Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine

September 8, 2017 updated by: Sinovac Biotech Co., Ltd

Phase IV, Open-labelled, Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine

The purpose of this study is to evaluate the 5-year Immune Persistence of Inactivated Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd.

Study Overview

Status

Completed

Conditions

Detailed Description

The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China,and a follow up study for phase III clinical trial has completed on March 2014.

On the basis of phase III, this study is the Phase IV, open-labelled research, in order to evaluate the 5-year immune persistence of EV71 vaccine.

Study Type

Observational

Enrollment (Actual)

343

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

  • China
    • Jiangsu
      • Yancheng, Jiangsu, China, 210009
        • Sheyang Center for Disease Control and Prevention

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

6 months to 2 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The studied subjects are infants aged 6-35 months old infants when enrolled into the phase III clinical trial, and they are children aged 6-8 years old five years after the EV71 vaccine /placebo injection.

Description

Inclusion Criteria:

In the prior phase III clinical trial, 10077 subjects in three counties (Ganyu, Sheyang and Taixing ) were enrolled ( Experimental group: 5044; Control group: 5043 ), with 1293 of them in immunogenicity subgroup (Experimental group: 648; Control group: 645). In Sheyang county, 3351 subjects were enrolled (Experimental group: 1676 ; Control group :1675) , with 435 of them in immunogenicity subgroup (Experimental group: 418 ; Control group :418).

The subjects in Sheyang immunogenicity subgroup with the following conditions were included in this study:

  • Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study
  • Received at least one injection of EV71 vaccine or the placebo in the phase III clinical trial
  • Finished the blood sampling 64 months after the vaccination

Exclusion Criteria:

  • Received extra EV71 vaccination after the phase III clinical trial
  • Refused to join the study

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
EV71 vaccine group
The group which received two doses EV71 vaccine (400U/0.5ml) on day 0,28 in phase III clinical trial.
Placebo group
The group which received two doses placebo (0U/0.5ml) on day 0,28 in phase III clinical trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The seropositive rate of EV71 neutralizing antibody-1
Time Frame: 5 years (64 months)
Calculated based on the cutoff value of 1:8
5 years (64 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The seropositive rate of EV71 neutralizing antibody-2
Time Frame: 5 years (64 months)
Calculated based on the cutoff value of 1:16
5 years (64 months)
The seropositive rate of EV71 neutralizing antibody-3
Time Frame: 5 years (64 months)
Calculated based on the cutoff value of 1:32
5 years (64 months)
The GMT of EV71 neutralizing antibody
Time Frame: 5 years (64 months)
The GMT of EV71 neutralizing antibody 64 months after the first dose injection
5 years (64 months)

Collaborators and Investigators

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

Sponsor

Sinovac Biotech Co., Ltd

Investigators

  • Principal Investigator: Yuemei Hu, Jiangsu Provicial Center for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 20, 2017

Primary Completion (ACTUAL)

May 21, 2017

Study Completion (ACTUAL)

May 21, 2017

Study Registration Dates

First Submitted

September 8, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (ACTUAL)

September 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 8, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-EV71-4007

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.

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