Hepatitis A VaccinePhase 3VITHA-CNCT03654664
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine
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 10 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months. Read more about this study
- Who is it for?
- Ages 12 to 23 monthsHealthy 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 20 Jun 2017to 24 Jun 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 12 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A child whose parents or representative provided written consent
- A Korean child aged 12-23 months on the day of the first vaccination
- No history of hepatitis A or a having hepatitis A vaccination
- A child who was determined by the investigator that there is no problem with the participation in the clinical study according to the medical history and physical examination results
Who cannot join
- Tympanic temperature of 38℃ 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
- Disorders in the immune system, or congenital or acquired immunodeficient diseases
- Received immunosuppressive dose of systemic corticosteroids therapy within 12weeks days before vaccination
- A child with uncontrolled epilepsy or neurological disorders
Show all 11Show fewer
- Planned with other vaccine within 4 weeks after the vaccination date
- Administered with other vaccine within 4 weeks prior to the vaccination date
- Used immunoglobulin formulation or human plasma, or received a transfusion within 12 weeks prior to the vaccination date
- A child who has participated or is participating in another clinical trial within 12 weeks prior to the vaccination date(systemic corticosteroids administered at doses corresponding to ≤0.5 mg/kg/day of prednisolone for 14 consecutive days or less is exceptionally allowed)
- Other reasons not specified above that, in the opinion of the investigator, may make the subject ineligible to participate in the study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Korea University Ansan Hospital
Ansan, 15355
Chanwon Fatima Hospital
Changwon, 51394
KeiMyung University Dongsan Medical Center
Daegu
The Catholic University of Korea, Incheon St.Mary's Hospital
Incheon, Bupyeong-gu, 403-720
Gachon University Gil Hospital
Incheon
Hanil General Hospital
Seoul, 01450
Korea cancer center Hospital
Seoul, 01812
Nowon Eulji Medical center , Eulji University
Seoul, 01830
The Catholic University of Korea, St.Vincent's Hospital.
Suwon, Gyeonggi-do, 442-723
Wonju Sevrance Christian Hospital
Wŏnju
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 Korean Healthy Children Aged 12~23 Months
The purpose of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months.
Read the detailed description
The objective of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose (administered twice in total at an interval of 6 months) of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months.
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
Inactivated hepatitis A virus antigen 250 U (Name of viral strain: TZ84)
Havrix InjBiological
720 ELISA/0.5 mL Junior (Inactivated hepatitis A virus antigen 160 U (Name of viral strain: HM175 Inj)
| Study group | Role | What they receive |
|---|---|---|
| inactivated hepatitis A vaccine | Experimental | A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months. Receives: Biological: Inactivated hepatitis A vaccine |
| Havrix Inj | Active comparator | A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months. 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 administration of the investigational product
Secondary outcomes (1)
Antibody titer (GMT)
The basic statistics of the antibody titer (GMT) at 1 month after the second vaccination
Measured: 1 month after the second 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 start20 Jun 2017
- Primary completion24 Jun 2019
- Study completion24 Jun 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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- HJ Cho, Study director, BORYUNGPHARM. CO., LTD.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654664
- Sponsor's protocol ID
- BR-HAV-CT-301
- Acronym
- VITHA-C
- Status last verified
- Jul 2023
- First submitted
- 29 Aug 2018
- Last updated
- 7 Jul 2023
- 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 7 Jul 2023. 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 Korean Healthy Children Aged 12~23 Months
- ClinicalTrials.gov ID
- NCT03654664
- Acronym / sponsor ID
- VITHA-C / BR-HAV-CT-301
- Conditions
- Hepatitis A Vaccine
- Keywords
- Hepatitis A vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 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 purpose of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months.
Detailed description
The objective of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose (administered twice in total at an interval of 6 months) of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months.
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 vaccineA 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months. |
| Havrix Inj | Active comparator | Biological: Havrix InjA 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months. |
Who may qualify
- Ages
- 12 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- A child whose parents or representative provided written consent
- A Korean child aged 12-23 months on the day of the first vaccination
- No history of hepatitis A or a having hepatitis A vaccination
- A child who was determined by the investigator that there is no problem with the participation in the clinical study according to the medical history and physical examination results
Key exclusion criteria (11 listed)
- Tympanic temperature of 38℃ 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
- Disorders in the immune system, or congenital or acquired immunodeficient diseases
- Received immunosuppressive dose of systemic corticosteroids therapy within 12weeks days before 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 vaccineInactivated hepatitis A virus antigen 250 U (Name of viral strain: TZ84) | Biological | inactivated hepatitis A vaccine |
| Havrix Inj720 ELISA/0.5 mL Junior (Inactivated hepatitis A virus antigen 160 U (Name of viral strain: HM175 Inj) | Biological | Havrix Inj |
Primary outcome
Seroconversion rate
Time frame: 1 month after the second administration of the investigational product
Seroconversion criteria: Anti-HAV 20 IU/L or above
1 secondary outcome
Antibody titer (GMT)
Time frame: 1 month after the second 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 7 Jul 2023.
- 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.
HJ Cho study director
BORYUNGPHARM. CO., LTD.
10 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 10 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 11 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 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 administration of the investigational product). 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 7 Jul 2023.