Safety and Immunogenicity Study of an Inactivated Hepatitis A Vaccine - Full Text View

Sponsored by:	Sinovac Biotech Co., Ltd
Information provided by:	Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:	NCT00534885

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 IV

MedlinePlus related topics: Hepatitis Hepatitis A

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Phase Ⅳ Clinical Trial for Three Consecutive Lots of an Inactivated Hepatitis A Vaccine

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
1: Lot 1: Experimental	Biological: inactivated hepatitis A vaccine Healive® two-dose regimen with 6 months apart
2: Lot 2: Experimental	Biological: inactivated hepatitis A vaccine Healive® two-dose regimen with 6 months apart
3: Lot 3: Experimental	Biological: inactivated hepatitis A vaccine Healive® two-dose regimen with 6 months apart
4: control vaccine: Active Comparator	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

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

Keywords provided by Sinovac Biotech Co., Ltd:

vaccine

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Picornaviridae Infections
Hepatitis, Viral, Human
Hepatitis A
Enterovirus Infections

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases
Digestive System Diseases

Picornaviridae Infections
Hepatitis, Viral, Human
Hepatitis A
Enterovirus Infections

ClinicalTrials.gov processed this record on May 07, 2009