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

Hepatitis A Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002065
• Other study ID #: PRO-HA-4013 version 2.0
• Status: Completed
• Phase: N/A
• First received: November 28, 2013
• Last updated: July 12, 2016
• Start date: October 2008
• Est. completion date: June 2014

Study information

• Verified date: April 2016
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: June 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 35 Months

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A

Intervention

Biological:
• Inactivated HAV vaccine
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

Locations

Country	Name	City	State
China	Tianjin center for disease prevention and control	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The geometric mean concentration (GMC) of anti-hepatitis A virus (HAV) antibodies in serum 60 months after vaccination	to evaluate the immune persistence of anti-HAV antibodies in serum	60 months after vaccination	No