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

Sponsor

Boryung Pharmaceutical Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT03654677

Collaborator

(none)

253

Enrollment

Locations

Arms

16.4

Actual Duration (Months)

21.1

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis A Vaccine	Biological: inactivated hepatitis A vaccine Biological: Havrix Inj	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

253 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 19, 2017

Actual Primary Completion Date :

Oct 12, 2018

Actual Study Completion Date :

Jan 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: inactivated hepatitis A vaccine Inactivated hepatitis A virus antigen 500U(Name of viral strain: TZ84)	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.
Active Comparator: Havrix Inj 1440 ELISA/mL_Adult Inj.(Name of Viral strain: HM175 Inj)	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.

Arm

Intervention/Treatment

Experimental: inactivated hepatitis A vaccine

Inactivated hepatitis A virus antigen 500U(Name of viral strain: TZ84)

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.

Active Comparator: Havrix Inj

1440 ELISA/mL_Adult Inj.(Name of Viral strain: HM175 Inj)

Biological: Havrix Inj

Outcome Measures

Primary Outcome Measures

Seroconversion rate [1 month after the second vaccination]
Seroconversion criteria: Anti-HAV 20 IU/L or above

Secondary Outcome Measures

Seroconversion rate [1 month after the first vaccination]
Seroconversion rate at 1 month after the first vaccination

Other Outcome Measures

Safety endpoint (Adverse events) [Approximately 12 months after a consent to the participation]
Adverse events observed within 30 minutes after vaccination, solicited adverse events/adverse drug reactions, and unsolicited adverse events/adverse drug reactions through a diary, serious adverse events/adverse drug reactions

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Males and females aged 16 years or older on the day of the first vaccination
No history of hepatitis A or having hepatitis A vaccination
Provided consent to the participation in the study voluntarily after receiving explanations about the objective, method, effect, etc. of this clinical study
Determined by the investigator to be able to be followed up during the study period

Exclusion Criteria:

A positive result (Anti-HAV 20 IU/L or above) in an hepatitis A antibody test at the time of screening
Positive hepatitis type B antigen at the time of screening
The following blood test results at the time of screening
ALT: More than 1.5 times the upper limit of normal
AST: More than 1.5 times the upper limit of normal
Total bilirubin: More than 1.5 times the upper limit of normal
Tympanic temperature of 38°C or above within 48 hours prior to the vaccination or on the day of vaccination
Moderate to severe acute or chronic infectious disease on the day of vaccination
History of sensitivity to the following drugs: neomycin, formaldehyde, gentamicin sulfate, any preventive vaccines
Congenital or acquired immunodeficient disease, or receiving immunosuppressive therapy
Received immunosuppressive dose of systemic corticosteroids therapy within 12weeks days before vaccination
uncontrolled epilepsy or neurological disorders
Administered with other vaccine within 4 weeks prior to the screening
Planned with other vaccine within 4 weeks after the vaccination date
Used immunoglobulin formulation or human plasma, or received a transfusion within 12 weeks prior to the screening
Participated in another clinical study within 12 weeks prior to the screening, or currently participating
Pregnant women or breast-feeding women
Other reasons not specified above that, in the opinion of the principal investigator, may make the subject ineligible to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Catholic University of Korea, Seoul St.Mary's Hospital	Seoul	Banpo-dong, Seocho-gu	Korea, Republic of	137-701
2	The Catholic University of Korea, Incheon St.Mary's Hospital	Incheon	Bupyeong-gu	Korea, Republic of	403-720
3	The Catholic University of Korea,Uijeongbu St.Mary's Hospital	Uijeongbu	Gyeonggi-do	Korea, Republic of	480-717
4	The Catholic University of Korea, Bucheon St.Mary's Hospital	Bucheon	Kyunggi-Do	Korea, Republic of	420-717
5	The Catholic University of Korea,Yeouido St.Mary's Hospital	Seoul	Yeongdeungpo-gu	Korea, Republic of	150-713
6	Hallym University Medical Center	Seoul	Yeongdeungpo-gu	Korea, Republic of
7	Soon chung hyang university hospita	Bucheon		Korea, Republic of
8	Inje university Ilsan Paik hospital	Ilsan		Korea, Republic of
9	Ewha Womans University Mokdong Hospital	Seoul		Korea, Republic of
10	Hanyang university medical center	Seoul		Korea, Republic of
11	Kyunghee university hospital	Seoul		Korea, Republic of
12	Soon Chun Hyang university hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Boryung Pharmaceutical Co., Ltd

Investigators

Principal Investigator: Jung Hyun Choi, Incheon St.Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boryung Pharmaceutical Co., Ltd

ClinicalTrials.gov Identifier:

NCT03654677

Other Study ID Numbers:

BR-HAV-CT-302

First Posted:

Aug 31, 2018

Last Update Posted:

Mar 23, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Boryung Pharmaceutical Co., Ltd

Hepatitis A Vaccine

Additional relevant MeSH terms:

Hepatitis A

Hepatitis

Study Results

No Results Posted as of Mar 23, 2020