NCT02002065

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

The Phase IV, Open-labelled, Follow-up Study to Evaluate the Five-year Immune Persistence of One Injection of Inactivated or Attenuated Alive Hepatitis A Vaccine in Healthy Chinese Children

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 332 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Months – 35 Months
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis A

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-10-01
• Primary completion: 2013-11-01
• Completion: 2014-06-01
• First posted: 2013-12-05
• Last updated: 2016-07-14

Locations

1 site across 1 country: China