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

PHASE3CompletedINTERVENTIONAL
Enrollment

253

Participants

Timeline

Start Date

September 19, 2017

Primary Completion Date

October 12, 2018

Study Completion Date

January 31, 2019

Conditions
Hepatitis A Vaccine
Interventions
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.

Trial Locations (12)

137-701

The Catholic University of Korea, Seoul St.Mary's Hospital, Seoul

403-720

The Catholic University of Korea, Incheon St.Mary's Hospital, Incheon

420-717

The Catholic University of Korea, Bucheon St.Mary's Hospital, Bucheon-si

480-717

The Catholic University of Korea,Uijeongbu St.Mary's Hospital, Uijeongbu-si

150-713

The Catholic University of Korea,Yeouido St.Mary's Hospital, Seoul

Unknown

Hallym University Medical Center, Seoul

Soon chung hyang university hospita, Bucheon-si

Inje university Ilsan Paik hospital, Ilsan

Ewha Womans University Mokdong Hospital, Seoul

Hanyang university medical center, Seoul

Kyunghee university hospital, Seoul

Soon Chun Hyang university hospital, Seoul

All Listed Sponsors
lead

Boryung Pharmaceutical Co., Ltd

INDUSTRY