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

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Sinovac

Status

Completed

Conditions

Hepatitis A

Treatments

Biological: Inactivated HAV vaccine
Biological: Attenuated alive HAV vaccine

Study type

Observational

Funder types

Industry

Identifiers

NCT02002065
PRO-HA-4013 version 2.0

Details and patient eligibility

About

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.

Full 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.

Enrollment

332 patients

Sex

All

Ages

18 to 35 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

332 participants in 2 patient groups

Inactivated HAV vaccine
Description:
Inactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose
Treatment:
Biological: Inactivated HAV vaccine
Attenuated alive HAV vaccine
Description:
Attenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose
Treatment:
Biological: Attenuated alive HAV vaccine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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