Clinical trial NCT03654677: To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine (VITHA-A)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis A Vaccine
Keywords: Hepatitis A Vaccine
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2018-08-31
Enrollment: 253
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Seroconversion rate
timeFrame: 1 month after the second vaccination
Secondary outcomes:
measure: Seroconversion rate
timeFrame: 1 month after the first vaccination
Other outcomes:
measure: Safety endpoint (Adverse events)
timeFrame: Approximately 12 months after a consent to the participation
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St.Mary's Hospital
state: Banpo-dong, Seocho-gu
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St.Mary's Hospital
state: Bupyeong-gu
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea,Uijeongbu St.Mary's Hospital
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon St.Mary's Hospital
state: Kyunggi-Do
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea,Yeouido St.Mary's Hospital
state: Yeongdeungpo-gu
city: Seoul
country: Korea, Republic of
facility: Hallym University Medical Center
state: Yeongdeungpo-gu
city: Bucheon
country: Korea, Republic of
facility: Soon chung hyang university hospita
city: Ilsan
country: Korea, Republic of
facility: Inje university Ilsan Paik hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang university medical center
city: Seoul
country: Korea, Republic of
facility: Kyunghee university hospital
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang university hospital
Study officials:
affiliation: Incheon St.Mary's Hospital
name: Jung Hyun Choi
role: PRINCIPAL_INVESTIGATOR
References: