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

NCT02002065 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 332

Last updated 2016-07-14

No results posted yet for this study

Summary

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.

Conditions

  • Hepatitis A

Interventions

BIOLOGICAL

Inactivated HAV vaccine

Inactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose

BIOLOGICAL

Attenuated alive HAV vaccine

Attenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zhi-Lun Zhang · Tianjin Center for Diseases Control and Prevention

Eligibility

Min Age
18 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2013-11-30
Completion
2014-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02002065 on ClinicalTrials.gov