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Safety, Immunogenicity, and Immune Persistence Study of an Inactivated Hepatitis A Vaccine

Primary Purpose

Hepatitis A

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Healive® Lot 1
Healive® Lot 2
Healive® Lot 3
Havrix
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis A focused on measuring inactivated hepatitis A vaccine, Healive, safety, immunogenicity, immune persistence

Eligibility Criteria

12 Months - 10 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Changzhou City Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

1: Healive® Lot 1

2: Healive® Lot 2

3: Healive® Lot 3

4: control vaccine (Havrix)

Arm Description

Outcomes

Primary Outcome Measures

Anti-HAV titer
To evaluate the immune responses to the inactivated hepatitis A vaccine by detecting the anti-HAV titer using microparticle enzyme immunoassay (MEIA) assay.

Secondary Outcome Measures

Solicited adverse reactions (AE): local reactions and systematic reactions
Solicited AEs were recorded until 72 hours after each injection
Unsolicited adverse reactions (AE)
Unsolicited AEs were recorded until month 7
Change of anti-HAV titer: geometry mean titer(GMT) and seroconversion rate
Blood samples were collected at day 0, month 1, 6, 7, 18, 30, 42, 54, 66,112, 138 after the first dose to assess the change of long-term immune response. Anti-HAV antibodies were assessed by microparticle enzyme immunoassay (MEIA) assay (cut off: 20 mIU/ml)

Full Information

First Posted
September 24, 2007
Last Updated
August 29, 2019
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00534885
Brief Title
Safety, Immunogenicity, and Immune Persistence Study of an Inactivated Hepatitis A Vaccine
Official Title
The Phase Ⅳ Clinical Trial to Evaluate the Safety, Immunogenicity, and Immune Persistence of Three Consecutive Lots of an Inactivated Hepatitis A Vaccine in Healthy Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A double-blind, randomized and controlled clinical trial was conducted in healthy children 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®). 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis A
Keywords
inactivated hepatitis A vaccine, Healive, safety, immunogenicity, immune persistence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Healive® Lot 1
Arm Type
Experimental
Arm Title
2: Healive® Lot 2
Arm Type
Experimental
Arm Title
3: Healive® Lot 3
Arm Type
Experimental
Arm Title
4: control vaccine (Havrix)
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Healive® Lot 1
Intervention Description
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
Intervention Type
Biological
Intervention Name(s)
Healive® Lot 2
Intervention Description
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
Intervention Type
Biological
Intervention Name(s)
Healive® Lot 3
Intervention Description
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
Intervention Type
Biological
Intervention Name(s)
Havrix
Intervention Description
Inactivated hepatitis A vaccine manufactured by GlaxoSmithKline Biologicals; two-dose regimen with 6 months apart
Primary Outcome Measure Information:
Title
Anti-HAV titer
Description
To evaluate the immune responses to the inactivated hepatitis A vaccine by detecting the anti-HAV titer using microparticle enzyme immunoassay (MEIA) assay.
Time Frame
7 months after the first dose
Secondary Outcome Measure Information:
Title
Solicited adverse reactions (AE): local reactions and systematic reactions
Description
Solicited AEs were recorded until 72 hours after each injection
Time Frame
72 hours after each injection
Title
Unsolicited adverse reactions (AE)
Description
Unsolicited AEs were recorded until month 7
Time Frame
7 months after the first dose
Title
Change of anti-HAV titer: geometry mean titer(GMT) and seroconversion rate
Description
Blood samples were collected at day 0, month 1, 6, 7, 18, 30, 42, 54, 66,112, 138 after the first dose to assess the change of long-term immune response. Anti-HAV antibodies were assessed by microparticle enzyme immunoassay (MEIA) assay (cut off: 20 mIU/ml)
Time Frame
baseline (day 0), month 1, 6, 7, 18, 30, 42, 54, 66,112,138 after the first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Yu Chen
Organizational Affiliation
Changzhou City Centre for Diseases Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changzhou City Center for Disease Control and Prevention
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China

12. IPD Sharing Statement

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Safety, Immunogenicity, and Immune Persistence Study of an Inactivated Hepatitis A Vaccine

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