NCT05613127

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Boryung Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 24 Months – 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis A
• Hep A

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-07-01
• Completion: 2024-11-01
• First posted: 2022-11-14
• Last updated: 2022-11-14

Locations

2 sites across 2 countries: South Korea, Thailand