NCT03654664

To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Hepatitis A Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated hepatitis A vaccine	Inactivated hepatitis A virus antigen 250 U (Name of viral strain: TZ84)
BIOLOGICAL	Havrix Inj	720 ELISA/0.5 mL Junior (Inactivated hepatitis A virus antigen 160 U (Name of viral strain: HM175 Inj)

Timeline

• Start date: 2017-06-20
• Primary completion: 2019-06-24
• Completion: 2019-06-24
• First posted: 2018-08-31
• Last updated: 2023-07-07

Locations

10 sites across 1 country: South Korea