Hepatitis A VaccinePhase 3NCT03654677
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine (VITHA-A)
A Phase 3 study testing inactivated hepatitis A vaccine and Havrix Inj in people with Hepatitis A Vaccine, run by Boryung Pharmaceutical Co., Ltd at 12 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A Vaccine
- What is being tested?
- inactivated hepatitis A vaccine and Havrix Inj
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 19 Sep 2017to 31 Jan 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, Gyeonggi-do, 420-717
Soon chung hyang university hospita
Bucheon-si
Inje university Ilsan Paik hospital
Ilsan
The Catholic University of Korea, Incheon St.Mary's Hospital
Incheon, Bupyeong-gu, 403-720
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, Banpo-dong, Seocho-gu, 137-701
The Catholic University of Korea,Yeouido St.Mary's Hospital
Seoul, Yeongdeungpo-gu, 150-713
Hallym University Medical Center
Seoul, Yeongdeungpo-gu
Ewha Womans University Mokdong Hospital
Seoul
Hanyang university medical center
Seoul
Kyunghee university hospital
Seoul
Soon Chun Hyang university hospital
Seoul
The Catholic University of Korea,Uijeongbu St.Mary's Hospital
Uijeongbu-si, Gyeonggi-do, 480-717
About this study
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
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.
Read the 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.
- Conditions
- Hepatitis A Vaccine
- Being tested
- inactivated hepatitis A vaccine, Havrix Inj
- Keywords
- Hepatitis A Vaccine
- Medical subject headings
- Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inactivated hepatitis A vaccineBiological
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 InjBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| inactivated hepatitis A vaccine | Experimental | Inactivated hepatitis A virus antigen 500U(Name of viral strain: TZ84) Receives: Biological: inactivated hepatitis A vaccine |
| Havrix Inj | Active comparator | 1440 ELISA/mL_Adult Inj.(Name of Viral strain: HM175 Inj) Receives: Biological: Havrix Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate
Seroconversion criteria: Anti-HAV 20 IU/L or above
Measured: 1 month after the second vaccination
Secondary outcomes (1)
Seroconversion rate
Seroconversion rate at 1 month after the first vaccination
Measured: 1 month after the first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start19 Sep 2017
- Primary completion12 Oct 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis A VaccineStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jung Hyun Choi, Principal investigator, Incheon St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654677
- Sponsor's protocol ID
- BR-HAV-CT-302
- Status last verified
- Mar 2020
- First submitted
- 29 Aug 2018
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03654677
- Acronym / sponsor ID
- BR-HAV-CT-302
- Conditions
- Hepatitis A Vaccine
- Keywords
- Hepatitis A Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 12 Oct 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inactivated hepatitis A vaccine | Experimental | Biological: inactivated hepatitis A vaccineInactivated hepatitis A virus antigen 500U(Name of viral strain: TZ84) |
| Havrix Inj | Active comparator | Biological: Havrix Inj1440 ELISA/mL_Adult Inj.(Name of Viral strain: HM175 Inj) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inactivated hepatitis A vaccineA 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 | inactivated hepatitis A vaccine |
| Havrix InjA 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 |
Primary outcome
Seroconversion rate
Time frame: 1 month after the second vaccination
Seroconversion criteria: Anti-HAV 20 IU/L or above
1 secondary outcome
Seroconversion rate
Time frame: 1 month after the first vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Hyun Choi principal investigator
Incheon St.Mary's Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing inactivated hepatitis A vaccine and Havrix Inj in people with Hepatitis A Vaccine, run by Boryung Pharmaceutical Co., Ltd at 12 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate (time frame: 1 month after the second vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.