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To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24mons-15yrs

Primary Purpose

Hepatitis A, Hep A

Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL
HAVRIX 720 Junior 0.5 mL
Sponsored by
Boryung Biopharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis A focused on measuring Hepatitis A, Hepatitis A vaccine, Vaccine, Hep A, HAV

Eligibility Criteria

24 Months - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy male or female children ≥ 24 months and ≤ 15 years old on the day of first vaccination Subjects with no history of hepatitis A and no previous vaccination against hepatitis A Written informed consent obtained from the subject's legal representative (parents or representative) Children who no health issues based on medical history and physical examination as judged by the investigator Exclusion Criteria Tympanic temperature of 38.0℃ or above within 48 hours prior to vaccination or on the day of vaccination Uncontrolled epilepsy or neurological disorder History of thrombocytopenia or has a risk of bleeding History of hypersensitivity to the following: neomycin, formaldehyde, gentamicin sulfate, any vaccine Severe acute or chronic infectious disease on the day of vaccination Congenital / acquired immunodeficiency or receiving immunosuppressive therapy Received immunosuppressive dose of systemic corticosteroids within 12 weeks prior to the first vaccination with the IP (Investigational Product) (equivalent potency of ≥ prednisolone 20 mg/day or equivalent potency of ≥ prednisolone 2.0 mg/kg/day in < 10kg of body weight for ≥ 14 consecutive days) Administration of any other vaccine within 4 weeks prior to Screening Planned administration of any other vaccine within 4 weeks after the last vaccination of the investigational product Administration of immunoglobulins or blood products or received blood transfusion within 12 weeks prior to Screening Currently participating in another clinical trial or administered / applied other investigational product / medical device within 6 months prior to Screening Ineligibility for participate in the study for other reasons as determined by the investigator

Sites / Locations

  • The Catholic University of Korea, ST. Vincent's Hospital
  • Maharaj Nakorn Chiang Mai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test group

Control group

Arm Description

Inactivated Hepatitis A vaccine

Inactivated Hepatitis A vaccine

Outcomes

Primary Outcome Measures

Anti-HAV seroconversion rate at 4 weeks after the second vaccination
Seroconversion: anti-HAV ≥ 20 mIU/mL after the second vaccination in subjects with anti-HAV < 20 mIU/mL at baseline

Secondary Outcome Measures

GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination
GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination
GMR (Geometric Mean Ratio, GMC Visit 6/GMC Visit 1) measured with anti-HAV antibody titers at 4 weeks after the second vaccination compared to those before the first vaccination
GMR (Geometric Mean Ratio, GMC Visit 6/GMC Visit 1) measured with anti-HAV antibody titers at 4 weeks after the second vaccination compared to those before the first vaccination

Full Information

First Posted
November 4, 2022
Last Updated
November 4, 2022
Sponsor
Boryung Biopharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05613127
Brief Title
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24mons-15yrs
Official Title
A Randomized, Double-blind, Multicenter, Multinational, Active-controlled, Parallel-designed Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24months to 15yrs
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Biopharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).
Detailed Description
The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval). This study is a two-group comparative study using a marketed inactivated hepatitis A vaccine (HAVRIX®, manufactured by GSK) as a control. The study will demonstrate non-inferiority of the test vaccine compared to the control vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis A, Hep A
Keywords
Hepatitis A, Hepatitis A vaccine, Vaccine, Hep A, HAV

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Description
Inactivated Hepatitis A vaccine
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Inactivated Hepatitis A vaccine
Intervention Type
Biological
Intervention Name(s)
Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL
Intervention Description
Dosage and administration: pre-iflled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.
Intervention Type
Biological
Intervention Name(s)
HAVRIX 720 Junior 0.5 mL
Intervention Description
Dosage and administration: pre-filled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.
Primary Outcome Measure Information:
Title
Anti-HAV seroconversion rate at 4 weeks after the second vaccination
Description
Seroconversion: anti-HAV ≥ 20 mIU/mL after the second vaccination in subjects with anti-HAV < 20 mIU/mL at baseline
Time Frame
At Visit 6 (7 months after Day 1: first vaccination)
Secondary Outcome Measure Information:
Title
GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination
Description
GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination
Time Frame
At Visit 6 (7 months after Day 1: first vaccination)
Title
GMR (Geometric Mean Ratio, GMC Visit 6/GMC Visit 1) measured with anti-HAV antibody titers at 4 weeks after the second vaccination compared to those before the first vaccination
Description
GMR (Geometric Mean Ratio, GMC Visit 6/GMC Visit 1) measured with anti-HAV antibody titers at 4 weeks after the second vaccination compared to those before the first vaccination
Time Frame
At Visit 6 (7 months after Day 1: first vaccination)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male or female children ≥ 24 months and ≤ 15 years old on the day of first vaccination Subjects with no history of hepatitis A and no previous vaccination against hepatitis A Written informed consent obtained from the subject's legal representative (parents or representative) Children who no health issues based on medical history and physical examination as judged by the investigator Exclusion Criteria Tympanic temperature of 38.0℃ or above within 48 hours prior to vaccination or on the day of vaccination Uncontrolled epilepsy or neurological disorder History of thrombocytopenia or has a risk of bleeding History of hypersensitivity to the following: neomycin, formaldehyde, gentamicin sulfate, any vaccine Severe acute or chronic infectious disease on the day of vaccination Congenital / acquired immunodeficiency or receiving immunosuppressive therapy Received immunosuppressive dose of systemic corticosteroids within 12 weeks prior to the first vaccination with the IP (Investigational Product) (equivalent potency of ≥ prednisolone 20 mg/day or equivalent potency of ≥ prednisolone 2.0 mg/kg/day in < 10kg of body weight for ≥ 14 consecutive days) Administration of any other vaccine within 4 weeks prior to Screening Planned administration of any other vaccine within 4 weeks after the last vaccination of the investigational product Administration of immunoglobulins or blood products or received blood transfusion within 12 weeks prior to Screening Currently participating in another clinical trial or administered / applied other investigational product / medical device within 6 months prior to Screening Ineligibility for participate in the study for other reasons as determined by the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seoyeon Hong, BS
Phone
+82-2-740-4087
Email
brbio_co@boryungbio.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hari Jeon, PharmD
Phone
+82-2-740-4228
Email
hrjeon@boryungbio.co.kr
Facility Information:
Facility Name
The Catholic University of Korea, ST. Vincent's Hospital
City
Suwon
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong-Hyun Kim, MD
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tavitiya Sudjaritruk, M.D.

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 in Healthy Children Aged From 24mons-15yrs

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