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

Completed

• Conditions: Hepatitis A
• Interventions: Biological: Attenuated alive HAV vaccine; Biological: Inactivated HAV vaccine

• Registration Number: NCT02002065
• Lead Sponsor: Sinovac Biotech Co., Ltd

Brief 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.

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 Timeline

• Study Start: 2008-10
• Primary Completion: 2013-11
• Study First Submitted: 2013-11-28
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-05
• Study Completion: 2014-06
• Status Verified: 2016-04
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The geometric mean concentration (GMC) of anti-hepatitis A virus (HAV) antibodies in serum 60 months after vaccination	60 months after vaccination	to evaluate the immune persistence of anti-HAV antibodies in serum

Trial Locations

Locations (1)

Tianjin center for disease prevention and control; 🇨🇳 Tianjin, China