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Safety and Immunogenicity Study of an Inactivated Hepatitis A Vaccine

This study has been completed.
Sponsor:
Information provided by:
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT00534885
First received: September 24, 2007
Last updated: November 1, 2007
Last verified: September 2007
History of Changes
  Purpose

A double-blind, randomized and controlled clinical trial was conducted in healthy volunteers aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of a preservative-free inactivated hepatitis A vaccine (Healive®).


Condition Intervention Phase
Hepatitis A
 Biological: inactivated hepatitis A vaccine Healive®
Biological: inactivated hepatitis A vaccine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Phase Ⅳ Clinical Trial for Three Consecutive Lots of an Inactivated Hepatitis A Vaccine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sinovac Biotech Co., Ltd:

Primary Outcome Measures:
  • Anti-HAV titer: geometry mean titer(GMT) and seroconversion rate [ Time Frame: baseline, 1 month, 6 months and 7 months after the first dose ]

Secondary Outcome Measures:
  • Adverse reactions: local reactions and systematic reactions [ Time Frame: 1 month, 6 months and 7 months after the first dose ]

Enrollment: 400
Study Start Date: March 2006
Study Completion Date: October 2006
Arms Assigned Interventions
Experimental: 1: Lot 1 Biological: inactivated hepatitis A vaccine Healive®
two-dose regimen with 6 months apart
Experimental: 2: Lot 2 Biological: inactivated hepatitis A vaccine Healive®
two-dose regimen with 6 months apart
Experimental: 3: Lot 3 Biological: inactivated hepatitis A vaccine Healive®
two-dose regimen with 6 months apart
Active Comparator: 4: control vaccine Biological: inactivated hepatitis A vaccine
two-dose regimen with 6 months apart

Detailed Description:

The investigated vaccine is an inactivated, adjuvanted and preservative-free hepatitis A vaccine. Each dose contained 250 U HAV antigen in 0.5 milliliter.

Total 400 subjects were enrolled and assigned into four groups, each receiving one of the three lots of Healive® or an established control vaccine on the 0 and 6th month. Anti-HAV titers were determined on the 1st, 6th and 7th month. Anti-HAV titer over 20 mIU/ml is defined as seroprotection.

  Eligibility

Ages Eligible for Study:   12 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Health children from 1 to 10 years
  • Not participate in any other trial during the course of the trial
  • Informed consent

Exclusion Criteria:

  • Any history of allergic reactions or convulsions following vaccination
  • Other known or planned vaccination within 1 month prior to the study and during the study period
  • Any chronic illness/disease including virus hepatitis, tuberculosis and epilepsy
  • Presence of any congenital abnormality, upgrowth obstacle
  • Any history/suspicion/presence of neurology and Lunacy
  • Any current or foreseeable use of immunosuppressors (i.e. corticosteroids , immunoglobulins) within 1 month prior to the vaccination and during the period of the study
  • Contraindication to intramuscularly injection due to thrombocytopenia or other bleeding disorders
  • Abnormal ALT
  • Positive markers for anti-HAV and HBV（HBsAg）infection
  • Presence of fever at the time of vaccination, i.e. body temperature (by mouth) > 37.0 centigrade.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534885

Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
Principal Investigator: Wei-Ping Jiang Changzhou City Centre for Diseases Control and Prevention
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00534885     History of Changes
Other Study ID Numbers: PRO-HA-4006
Study First Received: September 24, 2007
Last Updated: November 1, 2007
Health Authority: China: Food and Drug Administration

Keywords provided by Sinovac Biotech Co., Ltd:
vaccine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on May 21, 2013