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To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine (VITHA-A)

Primary Purpose

Hepatitis A Vaccine

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
inactivated hepatitis A vaccine
Havrix Inj
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis A Vaccine focused on measuring Hepatitis A Vaccine

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Males and females aged 16 years or older on the day of the first vaccination
  • No history of hepatitis A or having hepatitis A vaccination
  • Provided consent to the participation in the study voluntarily after receiving explanations about the objective, method, effect, etc. of this clinical study
  • Determined by the investigator to be able to be followed up during the study period

Exclusion Criteria:

  • A positive result (Anti-HAV 20 IU/L or above) in an hepatitis A antibody test at the time of screening
  • Positive hepatitis type B antigen at the time of screening

  • The following blood test results at the time of screening

    • ALT: More than 1.5 times the upper limit of normal
    • AST: More than 1.5 times the upper limit of normal
    • Total bilirubin: More than 1.5 times the upper limit of normal
  • Tympanic temperature of 38°C or above within 48 hours prior to the vaccination or on the day of vaccination
  • Moderate to severe acute or chronic infectious disease on the day of vaccination
  • History of sensitivity to the following drugs: neomycin, formaldehyde, gentamicin sulfate, any preventive vaccines
  • Congenital or acquired immunodeficient disease, or receiving immunosuppressive therapy
  • Received immunosuppressive dose of systemic corticosteroids therapy within 12weeks days before vaccination
  • uncontrolled epilepsy or neurological disorders
  • Administered with other vaccine within 4 weeks prior to the screening
  • Planned with other vaccine within 4 weeks after the vaccination date
  • Used immunoglobulin formulation or human plasma, or received a transfusion within 12 weeks prior to the screening
  • Participated in another clinical study within 12 weeks prior to the screening, or currently participating
  • Pregnant women or breast-feeding women
  • Other reasons not specified above that, in the opinion of the principal investigator, may make the subject ineligible to participate in the study

Sites / Locations

  • The Catholic University of Korea, Seoul St.Mary's Hospital
  • The Catholic University of Korea, Incheon St.Mary's Hospital
  • The Catholic University of Korea,Uijeongbu St.Mary's Hospital
  • The Catholic University of Korea, Bucheon St.Mary's Hospital
  • The Catholic University of Korea,Yeouido St.Mary's Hospital
  • Hallym University Medical Center
  • Soon chung hyang university hospita
  • Inje university Ilsan Paik hospital
  • Ewha Womans University Mokdong Hospital
  • Hanyang university medical center
  • Kyunghee university hospital
  • Soon Chun Hyang university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

inactivated hepatitis A vaccine

Havrix Inj

Arm Description

Inactivated hepatitis A virus antigen 500U(Name of viral strain: TZ84)

1440 ELISA/mL_Adult Inj.(Name of Viral strain: HM175 Inj)

Outcomes

Primary Outcome Measures

Seroconversion rate
Seroconversion criteria: Anti-HAV 20 IU/L or above

Secondary Outcome Measures

Seroconversion rate
Seroconversion rate at 1 month after the first vaccination

Full Information

First Posted
August 29, 2018
Last Updated
March 19, 2020
Sponsor
Boryung Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03654677
Brief Title
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine (VITHA-A)
Official Title
A Randomized, Double-blind, Multi-center, Active Controlled, Parallel-designed, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Youths Above 16 Years or Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 19, 2017 (Actual)
Primary Completion Date
October 12, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate the safety and immunogenicity after one primary dose and one additional dose (administered twice at an interval of 6 months) of inactivated hepatitis A vaccine are administered in adolescents (16 years of age or older) or adults.
Detailed Description
For this, a two-group comparison study will be conducted using a previously approved inactivated hepatitis A vaccine (Havrix Inj., manufactured by GSK) as the control vaccine to prove that the immunogenicity of the test vaccine treatment group is not inferior to the control vaccine treatment group and to statistically confirm that there is no difference in safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis A Vaccine
Keywords
Hepatitis A Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inactivated hepatitis A vaccine
Arm Type
Experimental
Arm Description
Inactivated hepatitis A virus antigen 500U(Name of viral strain: TZ84)
Arm Title
Havrix Inj
Arm Type
Active Comparator
Arm Description
1440 ELISA/mL_Adult Inj.(Name of Viral strain: HM175 Inj)
Intervention Type
Biological
Intervention Name(s)
inactivated hepatitis A vaccine
Intervention Description
A single dose of the test vaccine or the control vaccine in the form of pre-filled syringe is injected intramuscularly into the deltoid muscle (not to be injected into the gluteal region), and additional vaccination is performed using the same vaccine and the same method at 6 months after the first vaccination.
Intervention Type
Biological
Intervention Name(s)
Havrix Inj
Intervention Description
A single dose of the test vaccine or the control vaccine in the form of pre-filled syringe is injected intramuscularly into the deltoid muscle (not to be injected into the gluteal region), and additional vaccination is performed using the same vaccine and the same method at 6 months after the first vaccination.
Primary Outcome Measure Information:
Title
Seroconversion rate
Description
Seroconversion criteria: Anti-HAV 20 IU/L or above
Time Frame
1 month after the second vaccination
Secondary Outcome Measure Information:
Title
Seroconversion rate
Description
Seroconversion rate at 1 month after the first vaccination
Time Frame
1 month after the first vaccination
Other Pre-specified Outcome Measures:
Title
Safety endpoint (Adverse events)
Description
Adverse events observed within 30 minutes after vaccination, solicited adverse events/adverse drug reactions, and unsolicited adverse events/adverse drug reactions through a diary, serious adverse events/adverse drug reactions
Time Frame
Approximately 12 months after a consent to the participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females aged 16 years or older on the day of the first vaccination No history of hepatitis A or having hepatitis A vaccination Provided consent to the participation in the study voluntarily after receiving explanations about the objective, method, effect, etc. of this clinical study Determined by the investigator to be able to be followed up during the study period Exclusion Criteria: A positive result (Anti-HAV 20 IU/L or above) in an hepatitis A antibody test at the time of screening Positive hepatitis type B antigen at the time of screening The following blood test results at the time of screening ALT: More than 1.5 times the upper limit of normal AST: More than 1.5 times the upper limit of normal Total bilirubin: More than 1.5 times the upper limit of normal Tympanic temperature of 38°C or above within 48 hours prior to the vaccination or on the day of vaccination Moderate to severe acute or chronic infectious disease on the day of vaccination History of sensitivity to the following drugs: neomycin, formaldehyde, gentamicin sulfate, any preventive vaccines Congenital or acquired immunodeficient disease, or receiving immunosuppressive therapy Received immunosuppressive dose of systemic corticosteroids therapy within 12weeks days before vaccination uncontrolled epilepsy or neurological disorders Administered with other vaccine within 4 weeks prior to the screening Planned with other vaccine within 4 weeks after the vaccination date Used immunoglobulin formulation or human plasma, or received a transfusion within 12 weeks prior to the screening Participated in another clinical study within 12 weeks prior to the screening, or currently participating Pregnant women or breast-feeding women Other reasons not specified above that, in the opinion of the principal investigator, may make the subject ineligible to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Hyun Choi
Organizational Affiliation
Incheon St.Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Catholic University of Korea, Seoul St.Mary's Hospital
City
Seoul
State/Province
Banpo-dong, Seocho-gu
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Incheon St.Mary's Hospital
City
Incheon
State/Province
Bupyeong-gu
ZIP/Postal Code
403-720
Country
Korea, Republic of
Facility Name
The Catholic University of Korea,Uijeongbu St.Mary's Hospital
City
Uijeongbu
State/Province
Gyeonggi-do
ZIP/Postal Code
480-717
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Bucheon St.Mary's Hospital
City
Bucheon
State/Province
Kyunggi-Do
ZIP/Postal Code
420-717
Country
Korea, Republic of
Facility Name
The Catholic University of Korea,Yeouido St.Mary's Hospital
City
Seoul
State/Province
Yeongdeungpo-gu
ZIP/Postal Code
150-713
Country
Korea, Republic of
Facility Name
Hallym University Medical Center
City
Seoul
State/Province
Yeongdeungpo-gu
Country
Korea, Republic of
Facility Name
Soon chung hyang university hospita
City
Bucheon
Country
Korea, Republic of
Facility Name
Inje university Ilsan Paik hospital
City
Ilsan
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hanyang university medical center
City
Seoul
Country
Korea, Republic of
Facility Name
Kyunghee university hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Soon Chun Hyang university hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine (VITHA-A)

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