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

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: NCT03654664
Recruitment Status : Unknown
Verified August 2018 by Boryung Pharmaceutical Co., Ltd.
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

Study Description
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Brief Summary:
The purpose of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months.

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

Detailed Description:

The objective of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose (administered twice in total at an interval of 6 months) of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months.

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 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 Korean Healthy Children Aged 12~23 Months
Actual Study Start Date : June 20, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : October 11, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: inactivated hepatitis A vaccine
A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months.
 Biological: Inactivated hepatitis A vaccine
Inactivated hepatitis A virus antigen 250 U (Name of viral strain: TZ84)
Active Comparator: Havrix Inj
A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months.
 Biological: Havrix Inj
720 ELISA/0.5 mL Junior (Inactivated hepatitis A virus antigen 160 U (Name of viral strain: HM175 Inj)


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


Secondary Outcome Measures :
  1. Antibody titer (GMT) [ Time Frame: 1 month after the second vaccination ]
    The basic statistics of the antibody titer (GMT) at 1 month after the second vaccination


Other Outcome Measures:
  1. Safety endpoints 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, physica [ 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, physical examination


Eligibility Criteria
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Ages Eligible for Study:   12 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A child whose parents or representative provided written consent
  • A Korean child aged 12-23 months on the day of the first vaccination
  • No history of hepatitis A or a having hepatitis A vaccination
  • A child who was determined by the investigator that there is no problem with the participation in the clinical study according to the medical history and physical examination results

Exclusion Criteria:

  • Tympanic temperature of 38℃ 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
  • Disorders in the immune system, or congenital or acquired immunodeficient diseases
  • Received immunosuppressive dose of systemic corticosteroids therapy within 12weeks days before vaccination
  • A child with uncontrolled epilepsy or neurological disorders
  • Planned with other vaccine within 4 weeks after the vaccination date
  • Administered with other vaccine within 4 weeks prior to the vaccination date
  • Used immunoglobulin formulation or human plasma, or received a transfusion within 12 weeks prior to the vaccination date
  • A child who has participated or is participating in another clinical trial within 12 weeks prior to the vaccination date(systemic corticosteroids administered at doses corresponding to ≤0.5 mg/kg/day of prednisolone for 14 consecutive days or less is exceptionally allowed)
  • Other reasons not specified above that, in the opinion of the investigator, may make the subject ineligible to participate in the study
Contacts and Locations
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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): NCT03654664


Locations
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Korea, Republic of
The Catholic University of Korea, Incheon St.Mary's Hospital
Incheon, Bupyeong-gu, Korea, Republic of, 403-720
The Catholic University of Korea, St.Vincent's Hospital.
Suwon-si, Gyeonggi-do, Korea, Republic of, 442-723
Korea University Ansan Hospital
Ansan, Korea, Republic of, 15355
Chanwon Fatima Hospital
Changwon, Korea, Republic of, 51394
KeiMyung University Dongsan Medical Center
Daegu, Korea, Republic of
Gachon University Gil Hospital
Incheon, Korea, Republic of
Hanil General Hospital
Seoul, Korea, Republic of, 01450
Korea cancer center Hospital
Seoul, Korea, Republic of, 01812
Nowon Eulji Medical center , Eulji University
Seoul, Korea, Republic of, 01830
Wonju Sevrance Christian Hospital
Wonju, Korea, Republic of
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
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Study Director: HJ Cho BORYUNGPHARM. CO., LTD.
More Information
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Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT03654664    
Other Study ID Numbers: BR- HAV-CT-301
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
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
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections