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

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

12 Months - 23 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Catholic University of Korea, Incheon St.Mary's Hospital
  • The Catholic University of Korea, St.Vincent's Hospital.
  • Korea University Ansan Hospital
  • Chanwon Fatima Hospital
  • KeiMyung University Dongsan Medical Center
  • Gachon University Gil Hospital
  • Hanil General Hospital
  • Korea cancer center Hospital
  • Nowon Eulji Medical center , Eulji University
  • Wonju Sevrance Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

inactivated hepatitis A vaccine

Havrix Inj

Arm Description

A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months.

A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Antibody titer (GMT)
The basic statistics of the antibody titer (GMT) at 1 month after the second vaccination

Full Information

First Posted
August 29, 2018
Last Updated
July 5, 2023
Sponsor
Boryung Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03654664
Brief Title
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine
Acronym
VITHA-C
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
June 24, 2019 (Actual)
Study Completion Date
June 24, 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 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.
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.

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
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inactivated hepatitis A vaccine
Arm Type
Experimental
Arm Description
A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months.
Arm Title
Havrix Inj
Arm Type
Active Comparator
Arm Description
A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months.
Intervention Type
Biological
Intervention Name(s)
Inactivated hepatitis A vaccine
Intervention Description
Inactivated hepatitis A virus antigen 250 U (Name of viral strain: TZ84)
Intervention Type
Biological
Intervention Name(s)
Havrix Inj
Intervention Description
720 ELISA/0.5 mL Junior (Inactivated hepatitis A virus antigen 160 U (Name of viral strain: HM175 Inj)
Primary Outcome Measure Information:
Title
Seroconversion rate
Description
Seroconversion criteria: Anti-HAV 20 IU/L or above
Time Frame
1 month after the second administration of the investigational product
Secondary Outcome Measure Information:
Title
Antibody titer (GMT)
Description
The basic statistics of the antibody titer (GMT) at 1 month after the second vaccination
Time Frame
1 month after the second vaccination
Other Pre-specified Outcome Measures:
Title
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
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, physical examination
Time Frame
Approximately 12 months after a consent to the participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HJ Cho
Organizational Affiliation
BORYUNGPHARM. CO., LTD.
Official's Role
Study Director
Facility Information:
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, St.Vincent's Hospital.
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Ansan
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Chanwon Fatima Hospital
City
Changwon
ZIP/Postal Code
51394
Country
Korea, Republic of
Facility Name
KeiMyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Hanil General Hospital
City
Seoul
ZIP/Postal Code
01450
Country
Korea, Republic of
Facility Name
Korea cancer center Hospital
City
Seoul
ZIP/Postal Code
01812
Country
Korea, Republic of
Facility Name
Nowon Eulji Medical center , Eulji University
City
Seoul
ZIP/Postal Code
01830
Country
Korea, Republic of
Facility Name
Wonju Sevrance Christian Hospital
City
Wonju
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine

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