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

Hepatitis A Vaccine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03654677
• Other study ID #: BR-HAV-CT-302
• Status: Completed
• Phase: Phase 3
• Start date: September 19, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: March 2020
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: January 31, 2019
• Est. primary completion date: October 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis A Vaccine

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Soon chung hyang university hospita	Bucheon
Korea, Republic of	The Catholic University of Korea, Bucheon St.Mary's Hospital	Bucheon	Kyunggi-Do
Korea, Republic of	Inje university Ilsan Paik hospital	Ilsan
Korea, Republic of	The Catholic University of Korea, Incheon St.Mary's Hospital	Incheon	Bupyeong-gu
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Hallym University Medical Center	Seoul	Yeongdeungpo-gu
Korea, Republic of	Hanyang university medical center	Seoul
Korea, Republic of	Kyunghee university hospital	Seoul
Korea, Republic of	Soon Chun Hyang university hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St.Mary's Hospital	Seoul	Banpo-dong, Seocho-gu
Korea, Republic of	The Catholic University of Korea,Yeouido St.Mary's Hospital	Seoul	Yeongdeungpo-gu
Korea, Republic of	The Catholic University of Korea,Uijeongbu St.Mary's Hospital	Uijeongbu	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety endpoint (Adverse events)	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	Approximately 12 months after a consent to the participation
Primary	Seroconversion rate	Seroconversion criteria: Anti-HAV 20 IU/L or above	1 month after the second vaccination
Secondary	Seroconversion rate	Seroconversion rate at 1 month after the first vaccination	1 month after the first vaccination