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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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ClinicalTrials.gov Identifier: NCT02002065
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hepatitis A Biological: Inactivated HAV vaccine Biological: Attenuated alive HAV vaccine

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.

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Study Type : Observational
Actual Enrollment : 332 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : October 2008
Actual Primary Completion Date : November 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. The geometric mean concentration (GMC) of anti-hepatitis A virus (HAV) antibodies in serum 60 months after vaccination [ Time Frame: 60 months after vaccination ]
    to evaluate the immune persistence of anti-HAV antibodies in serum


Biospecimen Retention:   Samples Without DNA
Serum samples were taken from subjects.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Chinese children aged 18 to 35 months old
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002065


Locations
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China
Tianjin center for disease prevention and control
Tianjin, China, 300000
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
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Principal Investigator: Zhi-Lun Zhang Tianjin Center for Diseases Control and Prevention
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT02002065    
Other Study ID Numbers: PRO-HA-4013 version 2.0
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: April 2016
Keywords provided by Sinovac Biotech Co., Ltd:
hepatitis A
inactivated hepatitis A vaccine
attenuated alive hepatitis A vaccine
immune persistence
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs