NCT03654677

To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine (VITHA-A)

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 Healthy Youths Above 16 Years or Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the safety and immunogenicity after one primary dose and one additional dose (administered twice at an interval of 6 months) of inactivated hepatitis A vaccine are administered in adolescents (16 years of age or older) or adults.

Detailed description

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	A single dose of the test vaccine or the control vaccine in the form of pre-filled syringe is injected intramuscularly into the deltoid muscle (not to be injected into the gluteal region), and additional vaccination is performed using the same vaccine and the same method at 6 months after the first vaccination.
BIOLOGICAL	Havrix Inj	A single dose of the test vaccine or the control vaccine in the form of pre-filled syringe is injected intramuscularly into the deltoid muscle (not to be injected into the gluteal region), and additional vaccination is performed using the same vaccine and the same method at 6 months after the first vaccination.

Timeline

• Start date: 2017-09-19
• Primary completion: 2018-10-12
• Completion: 2019-01-31
• First posted: 2018-08-31
• Last updated: 2025-05-22

Locations

12 sites across 1 country: South Korea