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

Sponsor

Boryung Biopharma Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05613127

Collaborator

(none)

106

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hepatitis A Hep A	Biological: Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL Biological: HAVRIX 720 Junior 0.5 mL	Phase 3

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Anti-HAV seroconversion rate at 4 weeks after the second vaccination [At Visit 6 (7 months after Day 1: first 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 [At Visit 6 (7 months after Day 1: first 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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Months to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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