Hepatitis APhase 3NCT05613127
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24mons-15yrs
A Phase 3 study testing Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL and HAVRIX 720 Junior 0.5 mL in people with Hepatitis A and Hep A, run by Boryung Biopharma Co., Ltd. at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval). Read more about this study
- Who is it for?
- Ages 24 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A, Hep A
- What is being tested?
- Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL and HAVRIX 720 Junior 0.5 mL
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2022to Nov 2024
- 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 24 months to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male or female children ≥ 24 months and ≤ 15 years old on the day of first vaccination
- Subjects with no history of hepatitis A and no previous vaccination against hepatitis A
- Written informed consent obtained from the subject's legal representative (parents or representative)
- Children who no health issues based on medical history and physical examination as judged by the investigator
Who cannot join
- Tympanic temperature of 38.0℃ or above within 48 hours prior to vaccination or on the day of vaccination
- Uncontrolled epilepsy or neurological disorder
- History of thrombocytopenia or has a risk of bleeding
- History of hypersensitivity to the following: neomycin, formaldehyde, gentamicin sulfate, any vaccine
- Severe acute or chronic infectious disease on the day of vaccination
- Congenital / acquired immunodeficiency or receiving immunosuppressive therapy
Show all 12Show fewer
- Received immunosuppressive dose of systemic corticosteroids within 12 weeks prior to the first vaccination with the IP (Investigational Product) (equivalent potency of ≥ prednisolone 20 mg/day or equivalent potency of ≥ prednisolone 2.0 mg/kg/day in < 10kg of body weight for ≥ 14 consecutive days)
- Administration of any other vaccine within 4 weeks prior to Screening
- Planned administration of any other vaccine within 4 weeks after the last vaccination of the investigational product
- Administration of immunoglobulins or blood products or received blood transfusion within 12 weeks prior to Screening
- Currently participating in another clinical trial or administered / applied other investigational product / medical device within 6 months prior to Screening
- Ineligibility for participate in the study for other reasons as determined by the investigator
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Korea1 site
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, 16247
Jong-Hyun Kim, MD
Thailand1 site
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
Tavitiya Sudjaritruk, M.D.
About this study
Official title: A Randomized, Double-blind, Multicenter, Multinational, Active-controlled, Parallel-designed Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24months to 15yrs
The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).
Read the detailed description
The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).
This study is a two-group comparative study using a marketed inactivated hepatitis A vaccine (HAVRIX®, manufactured by GSK) as a control. The study will demonstrate non-inferiority of the test vaccine compared to the control vaccine.
- Conditions
- Hepatitis A, Hep A
- Being tested
- Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL, HAVRIX 720 Junior 0.5 mL
- Keywords
- Hepatitis A, Hepatitis A vaccine, Vaccine, Hep A, HAV
- Medical subject headings
- Hepatitis A, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mLBiological
Dosage and administration: pre-iflled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.
HAVRIX 720 Junior 0.5 mLBiological
Dosage and administration: pre-filled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Inactivated Hepatitis A vaccine Receives: Biological: Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL |
| Control group | Active comparator | Inactivated Hepatitis A vaccine Receives: Biological: HAVRIX 720 Junior 0.5 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HAV seroconversion rate at 4 weeks after the second vaccination
Seroconversion: anti-HAV ≥ 20 mIU/mL after the second vaccination in subjects with anti-HAV < 20 mIU/mL at baseline
Measured: At Visit 6 (7 months after Day 1: first vaccination)
Secondary outcomes (2)
GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination
GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination
Measured: At Visit 6 (7 months after Day 1: first vaccination)
GMR (Geometric Mean Ratio, GMC Visit 6/GMC Visit 1) measured with anti-HAV antibody titers at 4 weeks after the second vaccination compared to those before the first vaccination
GMR (Geometric Mean Ratio, GMC Visit 6/GMC Visit 1) measured with anti-HAV antibody titers at 4 weeks after the second vaccination compared to those before the first vaccination
Measured: At Visit 6 (7 months after Day 1: first vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study startDec 2022 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis AStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boryung Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613127
- Sponsor's protocol ID
- BR-HAV-CT-303
- Status last verified
- Nov 2022
- First submitted
- 4 Nov 2022
- Last updated
- 14 Nov 2022
- Results posted
- 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 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Multinational, Active-controlled, Parallel-designed Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24months to 15yrs
- ClinicalTrials.gov ID
- NCT05613127
- Acronym / sponsor ID
- BR-HAV-CT-303
- Conditions
- Hepatitis A, Hep A
- Keywords
- Hepatitis A, Hepatitis A vaccine, Vaccine, Hep A, HAV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Boryung Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2022 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 14 Nov 2022 (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 immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).
Detailed description
The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).
This study is a two-group comparative study using a marketed inactivated hepatitis A vaccine (HAVRIX®, manufactured by GSK) as a control. The study will demonstrate non-inferiority of the test vaccine compared to the control vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Biological: Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mLInactivated Hepatitis A vaccine |
| Control group | Active comparator | Biological: HAVRIX 720 Junior 0.5 mLInactivated Hepatitis A vaccine |
Who may qualify
- Ages
- 24 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy male or female children ≥ 24 months and ≤ 15 years old on the day of first vaccination
- Subjects with no history of hepatitis A and no previous vaccination against hepatitis A
- Written informed consent obtained from the subject's legal representative (parents or representative)
- Children who no health issues based on medical history and physical examination as judged by the investigator
Key exclusion criteria (12 listed)
- Tympanic temperature of 38.0℃ or above within 48 hours prior to vaccination or on the day of vaccination
- Uncontrolled epilepsy or neurological disorder
- History of thrombocytopenia or has a risk of bleeding
- History of hypersensitivity to the following: neomycin, formaldehyde, gentamicin sulfate, any vaccine
- 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 |
|---|---|---|
| Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mLDosage and administration: pre-iflled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval. | Biological | Test group |
| HAVRIX 720 Junior 0.5 mLDosage and administration: pre-filled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval. | Biological | Control group |
Primary outcome
Anti-HAV seroconversion rate at 4 weeks after the second vaccination
Time frame: At Visit 6 (7 months after Day 1: first vaccination)
Seroconversion: anti-HAV ≥ 20 mIU/mL after the second vaccination in subjects with anti-HAV < 20 mIU/mL at baseline
2 secondary outcomes
GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination
Time frame: At Visit 6 (7 months after Day 1: first vaccination)
GMR (Geometric Mean Ratio, GMC Visit 6/GMC Visit 1) measured with anti-HAV antibody titers at 4 weeks after the second vaccination compared to those before the first vaccination
Time frame: At Visit 6 (7 months after Day 1: first vaccination)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL and HAVRIX 720 Junior 0.5 mL in people with Hepatitis A and Hep A, run by Boryung Biopharma Co., Ltd. at 2 sites in 2 countries.
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 12 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: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea, Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seoyeon Hong, BS (+82-2-740-4087, brbio_co@boryungbio.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-HAV seroconversion rate at 4 weeks after the second vaccination (time frame: At Visit 6 (7 months after Day 1: first 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 14 Nov 2022.