A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine

May 25, 2022 updated by: Sinovac Biotech Co., Ltd

An Open-labelled, Multicentered, Follow-up Study for a Phase III, Efficacy Trial to Evaluate the Two-year Efficacy, Safety, and Immune Persisitence of Inactivated Enterovirus Type 71 (EV71) Vaccine

The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China. The data from the phase III study suggested that the inactivated EV71 vaccine had protection effects on healthy Chinese infants against Hand, Foot and Mouth disease caused by EV71 within one-year surveillance period, and had clinically acceptable safety and good one-year immune persistence.

This study is the phase III, open-labelled, follow-up research, in order to evaluate the two-year efficacy, safety and immune persistence.

Study Type

Observational

Enrollment (Actual)

10077

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
      • Lianyungang, Jiangsu, China, 222100
        • Ganyu
      • Taizhou, Jiangsu, China, 225400
        • Taixing
      • Yancheng, Jiangsu, China, 224300
        • Sheyang

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

Probability Sample

Study Population

Healthy Chinese infants aged 6 to 35 months old

Description

Inclusion Criteria:

  • All subjects vaccinated at least one injection of EV71 vaccine or the placebo in the phase III efficacy trial.

Exclusion Criteria:

  • subjects who refuse to continue in 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
Intervention / Treatment
EV71 Vaccine
Inactivated vaccine (vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28
Biological: EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
Placebo
placebo in 5000 infants aged 6-35 months old on day0,28

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination
Time Frame: Within the second year after the second vaccination
to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71
Within the second year after the second vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The GMT of anti-EV71 antibodies in serum two years after second vaccination
Time Frame: 26 months after second vaccination
to evaluate the immune persistence of anti-EV71 antibodies in serum
26 months after second vaccination
Frequency of serious adverse events (SAEs) with the second year after the second vaccination
Time Frame: within the second year after the second vaccination
Frequency of serious adverse events in healthy infants during the oney-year follow-up period
within the second year after the second vaccination

Collaborators and Investigators

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

Sponsor

Sinovac Biotech Co., Ltd

Investigators

  • Principal Investigator: Feng-Cai Zhu, BS, Jiangsu Center for Diseases Control and Prevention

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

March 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-EV71-3003-0

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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