Safety, Immunogenicity, and Immune Persistence Study of an Inactivated Hepatitis A Vaccine
NCT ID: NCT00534885
Last Updated: 2019-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
400 participants
INTERVENTIONAL
2006-03-31
2017-10-31
Brief Summary
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Participants who completed their primary vaccination were invited to participate in the follow-up phase. Written informed consents were obtained from them. The follow-up study was open-label. These subjects were visited in the next 11 years for blood sampling and assessment of immune persistence induced by vaccination.
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Detailed Description
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Total 400 subjects were enrolled and assigned into four groups, each receiving one of the three lots of Healive® or an established control vaccine at month 0 and 6. Anti-HAV titers were determined at month 1, 6 and 7. Anti-HAV titer over 20 mIU/ml is defined as seroprotection.
After the full immunization schedule, written informed consents were obtained from subjects who would like to participate in the follow-up study. Blood samples of these subjects were collected at month 18, 30, 42, 54, 66, 112,138 after the first injection to evaluate the seroconversion rates (SCRs) and geometric mean concentrations (GMCs) of antibody against hepatitis A virus. Serological results of the follow-up study were then used to explore suitable statistical model for predicting the persistence of hepatitis A vaccine-induced antibodies.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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1: Healive® Lot 1
Healive® Lot 1
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
2: Healive® Lot 2
Healive® Lot 2
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
3: Healive® Lot 3
Healive® Lot 3
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
4: control vaccine (Havrix)
Havrix
Inactivated hepatitis A vaccine manufactured by GlaxoSmithKline Biologicals; two-dose regimen with 6 months apart
Interventions
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Healive® Lot 1
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
Healive® Lot 2
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
Healive® Lot 3
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
Havrix
Inactivated hepatitis A vaccine manufactured by GlaxoSmithKline Biologicals; two-dose regimen with 6 months apart
Eligibility Criteria
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Inclusion Criteria
* Not participate in any other trial during the course of the trial
* Informed consent
Exclusion Criteria
* 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.
12 Months
10 Years
ALL
Yes
Sponsors
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Sinovac Biotech Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Wen-Yu Chen
Role: PRINCIPAL_INVESTIGATOR
Changzhou City Centre for Diseases Control and Prevention
Locations
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Changzhou City Center for Disease Control and Prevention
Changzhou, Jiangsu, China
Countries
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Other Identifiers
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PRO-HA-4008 (11 Y follow-up)
Identifier Type: OTHER
Identifier Source: secondary_id
PRO-HA-4006
Identifier Type: -
Identifier Source: org_study_id
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