The Fifth-year Follow-up Study for the Phase IV Clinical Trial of Hepatitis A Vaccine in Healthy Children

July 12, 2016 updated by: Sinovac Biotech Co., Ltd

The Phase IV, Open-labelled, Follow-up Study to Evaluate the Five-year Immune Persistence of One Injection of Inactivated or Attenuated Alive Hepatitis A Vaccine in Healthy Chinese Children

The purpose of this follow-up study is to evaluate the five-year immune persistence of one injection of inactivated and attenuated alive hepatitis A vaccine in healthy children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the previous double-blind, randomized, phase IV clinical trial in 2008, 300 healthy Chinese children aged 18 to 35 months old were administered with one dose of inactivated and attenuated alive hepatitis A vaccine. Series of serum samples were taken for immunogenicity and immune persistence evaluation. Safety observations were performed after vaccination. This trial was also approved by Tianjin CDC Biomedical Ethics Committee in 2008.

This study is the fifth-year follow-up research for the previous clinical trial.

Study Type

Observational

Enrollment (Actual)

332

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
      • Tianjin, China, 300000
        • Tianjin center for disease prevention and control

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

1 year to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy Chinese children aged 18 to 35 months old

Description

Inclusion Criteria:

  • All subjects who received inactivated or attenuated alive HAV vaccine in the previous trial

Exclusion Criteria:

  • Subjects who refused to continue in the follow-up 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
Inactivated HAV vaccine
Inactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose
Biological: Inactivated HAV vaccine
Inactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose
Attenuated alive HAV vaccine
Attenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose
Biological: Attenuated alive HAV vaccine
Attenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The geometric mean concentration (GMC) of anti-hepatitis A virus (HAV) antibodies in serum 60 months after vaccination
Time Frame: 60 months after vaccination
to evaluate the immune persistence of anti-HAV antibodies in serum
60 months after 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: Zhi-Lun Zhang, Tianjin Center for Diseases 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

October 1, 2008

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 28, 2013

First Submitted That Met QC Criteria

December 4, 2013

First Posted (Estimate)

December 5, 2013

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-HA-4013 version 2.0

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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