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

NCT ID: NCT02002065

Last Updated: 2016-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

332 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Inactivated HAV vaccine

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

Inactivated HAV vaccine

Intervention Type BIOLOGICAL

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

Attenuated alive HAV vaccine

Intervention Type BIOLOGICAL

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

Interventions

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Inactivated HAV vaccine

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

Intervention Type BIOLOGICAL

Attenuated alive HAV vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

35 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sinovac Biotech Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhi-Lun Zhang

Role: PRINCIPAL_INVESTIGATOR

Tianjin Center for Diseases Control and Prevention

Locations

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Tianjin center for disease prevention and control

Tianjin, , China

Site Status

Countries

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China

References

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Zhang Z, Zhu X, Hu Y, Liang M, Sun J, Song Y, Yang Q, Ji H, Zeng G, Song L, Chen J. Five-year antibody persistence in children after one dose of inactivated or live attenuated hepatitis A vaccine. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-6. doi: 10.1080/21645515.2016.1278329. Epub 2017 Feb 14.

Reference Type DERIVED
PMID: 28319454 (View on PubMed)

Other Identifiers

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PRO-HA-4013 version 2.0

Identifier Type: -

Identifier Source: org_study_id

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