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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis A Vaccine
• Intervention / Treatment: Biological: Inactivated hepatitis A vaccine; Biological: Havrix Inj

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 Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of, 15355
    • Korea University Ansan Hospital
  • Changwon, Korea, Republic of, 51394
    • Chanwon Fatima Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Incheon, Korea, Republic of
    • Gachon University Gil Hospital
  • Seoul, Korea, Republic of, 01450
    • Hanil General Hospital
  • Seoul, Korea, Republic of, 01812
    • Korea Cancer Center Hospital
  • Seoul, Korea, Republic of, 01830
    • Nowon Eulji Medical center , Eulji University
  • Wonju, Korea, Republic of
    • Wonju Sevrance Christian Hospital
  • Bupyeong-gu
    • Incheon, Bupyeong-gu, Korea, Republic of, 403-720
      • The Catholic University of Korea, Incheon St.Mary's Hospital
  • Gyeonggi-do
    • Suwon-si, Gyeonggi-do, Korea, Republic of, 442-723
      • The Catholic University of Korea, St.Vincent's Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody titer (GMT)	The basic statistics of the antibody titer (GMT) at 1 month after the second vaccination	1 month after the second vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Approximately 12 months after a consent to the participation

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Investigators: Study Director: HJ Cho, BORYUNGPHARM. CO., LTD.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2017
• Primary Completion (Actual): June 24, 2019
• Study Completion (Actual): June 24, 2019

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Hepatitis A vaccine
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A
• Other Study ID Numbers: BR-HAV-CT-301

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