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

March 19, 2020 updated by: Boryung Pharmaceutical Co., Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

253

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Soon chung hyang university hospita
      • Ilsan, Korea, Republic of
        • Inje University Ilsan Paik Hospital
      • Seoul, Korea, Republic of
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of
        • Hanyang University Medical Center
      • Seoul, Korea, Republic of
        • KyungHee University Hospital
      • Seoul, Korea, Republic of
        • Soon Chun Hyang University Hospital
    • Banpo-dong, Seocho-gu
      • Seoul, Banpo-dong, Seocho-gu, Korea, Republic of, 137-701
        • The Catholic University of Korea, Seoul St.Mary's Hospital
    • Bupyeong-gu
      • Incheon, Bupyeong-gu, Korea, Republic of, 403-720
        • The Catholic University of Korea, Incheon St.Mary's Hospital
    • Gyeonggi-do
      • Uijeongbu, Gyeonggi-do, Korea, Republic of, 480-717
        • The Catholic University of Korea,Uijeongbu St.Mary's Hospital
    • Kyunggi-Do
      • Bucheon, Kyunggi-Do, Korea, Republic of, 420-717
        • The Catholic University of Korea, Bucheon St.Mary's Hospital
    • Yeongdeungpo-gu
      • Seoul, Yeongdeungpo-gu, Korea, Republic of, 150-713
        • The Catholic University of Korea,Yeouido St.Mary's Hospital
      • Seoul, Yeongdeungpo-gu, Korea, Republic of
        • Hallym University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: inactivated hepatitis A vaccine
Inactivated hepatitis A virus antigen 500U(Name of viral strain: TZ84)
Biological: inactivated hepatitis A vaccine
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.
ACTIVE_COMPARATOR: Havrix Inj
1440 ELISA/mL_Adult Inj.(Name of Viral strain: HM175 Inj)
Biological: Havrix Inj
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion rate
Time Frame: 1 month after the second vaccination
Seroconversion criteria: Anti-HAV 20 IU/L or above
1 month after the second vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion rate
Time Frame: 1 month after the first vaccination
Seroconversion rate at 1 month after the first vaccination
1 month after the first vaccination

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety endpoint (Adverse events)
Time Frame: Approximately 12 months after a consent to the participation
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
Approximately 12 months after a consent to the participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Investigators

  • Principal Investigator: Jung Hyun Choi, Incheon St.Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 19, 2017

Primary Completion (ACTUAL)

October 12, 2018

Study Completion (ACTUAL)

January 31, 2019

Study Registration Dates

First Submitted

August 29, 2018

First Submitted That Met QC Criteria

August 30, 2018

First Posted (ACTUAL)

August 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-HAV-CT-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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