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

May 19, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
253

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boryung Pharmaceutical Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 12, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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