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
1 other identifier
interventional
253
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2017
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2017
CompletedFirst Submitted
Initial submission to the registry
August 29, 2018
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedMay 22, 2025
March 1, 2020
1.1 years
August 29, 2018
May 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seroconversion rate
Seroconversion criteria: Anti-HAV 20 IU/L or above
1 month after the second vaccination
Secondary Outcomes (1)
Seroconversion rate
1 month after the first vaccination
Other Outcomes (1)
Safety endpoint (Adverse events)
Approximately 12 months after a consent to the participation
Study Arms (2)
inactivated hepatitis A vaccine
EXPERIMENTALInactivated hepatitis A virus antigen 500U(Name of viral strain: TZ84)
Havrix Inj
ACTIVE COMPARATOR1440 ELISA/mL\_Adult Inj.(Name of Viral strain: HM175 Inj)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, Banpo-dong, Seocho-gu, 137-701, South Korea
The Catholic University of Korea, Incheon St.Mary's Hospital
Incheon, Bupyeong-gu, 403-720, South Korea
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, Gyeonggi-do, 420-717, South Korea
The Catholic University of Korea,Uijeongbu St.Mary's Hospital
Uijeongbu-si, Gyeonggi-do, 480-717, South Korea
The Catholic University of Korea,Yeouido St.Mary's Hospital
Seoul, Yeongdeungpo-gu, 150-713, South Korea
Hallym University Medical Center
Seoul, Yeongdeungpo-gu, South Korea
Soon chung hyang university hospita
Bucheon-si, South Korea
Inje university Ilsan Paik hospital
Ilsan, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Hanyang university medical center
Seoul, South Korea
Kyunghee university hospital
Seoul, South Korea
Soon Chun Hyang university hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jung Hyun Choi
Incheon St.Mary's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2018
First Posted
August 31, 2018
Study Start
September 19, 2017
Primary Completion
October 12, 2018
Study Completion
January 31, 2019
Last Updated
May 22, 2025
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share