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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014