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

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