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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatitis A; Hep A
• Intervention / Treatment: Biological: Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL; Biological: HAVRIX 720 Junior 0.5 mL

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.

• Study Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Seoyeon Hong, BS; Phone Number: +82-2-740-4087; Email: brbio_co@boryungbio.co.kr
• Study Contact Backup: Name: Hari Jeon, PharmD; Phone Number: +82-2-740-4228; Email: hrjeon@boryungbio.co.kr

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of, 16247
    • The Catholic University of Korea, St. Vincent's Hospital
    • Contact: Jong-Hyun Kim, MD
• Thailand
  • Chiang Mai, Thailand
    • Maharaj Nakorn Chiang Mai Hospital
    • Contact: Tavitiya Sudjaritruk, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male or female children ≥ 24 months and ≤ 15 years old on the day of first vaccination
2. Subjects with no history of hepatitis A and no previous vaccination against hepatitis A
3. Written informed consent obtained from the subject's legal representative (parents or representative)
4. Children who no health issues based on medical history and physical examination as judged by the investigator

Exclusion Criteria

1. Tympanic temperature of 38.0℃ or above within 48 hours prior to vaccination or on the day of vaccination
2. Uncontrolled epilepsy or neurological disorder
3. History of thrombocytopenia or has a risk of bleeding
4. History of hypersensitivity to the following: neomycin, formaldehyde, gentamicin sulfate, any vaccine
5. Severe acute or chronic infectious disease on the day of vaccination
6. Congenital / acquired immunodeficiency or receiving immunosuppressive therapy
7. 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)
8. Administration of any other vaccine within 4 weeks prior to Screening
9. Planned administration of any other vaccine within 4 weeks after the last vaccination of the investigational product
10. Administration of immunoglobulins or blood products or received blood transfusion within 12 weeks prior to Screening
11. Currently participating in another clinical trial or administered / applied other investigational product / medical device within 6 months prior to Screening
12. Ineligibility for participate in the study for other reasons as determined by the investigator

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; Inactivated Hepatitis A vaccine	Biological: Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL; Dosage and administration: pre-iflled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.
Active Comparator: Control group; Inactivated Hepatitis A vaccine	Biological: HAVRIX 720 Junior 0.5 mL; Dosage and administration: pre-filled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At Visit 6 (7 months after Day 1: first vaccination)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At Visit 6 (7 months after Day 1: 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	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	At Visit 6 (7 months after Day 1: first vaccination)

Collaborators and Investigators

• Sponsor: Boryung Biopharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Vaccine; Hepatitis A; Hepatitis A vaccine; Hep A; HAV
• 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-303

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