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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03654677
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Hepatitis A Vaccine Biological: inactivated hepatitis A vaccine Biological: Havrix Inj Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : September 19, 2017
Actual Primary Completion Date : October 12, 2018
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Seroconversion rate [ Time Frame: 1 month after the second vaccination ]
    Seroconversion criteria: Anti-HAV 20 IU/L or above


Secondary Outcome Measures :
  1. Seroconversion rate [ Time Frame: 1 month after the first vaccination ]
    Seroconversion rate at 1 month after the first vaccination


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654677


Locations
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Korea, Republic of
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, Banpo-dong, Seocho-gu, Korea, Republic of, 137-701
The Catholic University of Korea, Incheon St.Mary's Hospital
Incheon, Bupyeong-gu, Korea, Republic of, 403-720
The Catholic University of Korea,Uijeongbu St.Mary's Hospital
Uijeongbu, Gyeonggi-do, Korea, Republic of, 480-717
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon, Kyunggi-Do, Korea, Republic of, 420-717
The Catholic University of Korea,Yeouido St.Mary's Hospital
Seoul, Yeongdeungpo-gu, Korea, Republic of, 150-713
Hallym University Medical Center
Seoul, Yeongdeungpo-gu, Korea, Republic of
Soon chung hyang university hospita
Bucheon, Korea, Republic of
Inje university Ilsan Paik hospital
Ilsan, 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
Seoul, Korea, Republic of
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
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Principal Investigator: Jung Hyun Choi Incheon St.Mary's Hospital
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Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT03654677    
Other Study ID Numbers: BR-HAV-CT-302
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boryung Pharmaceutical Co., Ltd:
Hepatitis A Vaccine
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections