Japanese EncephalitisPhase 4BR-JELITENCT02532569
Long-term Immunogenicity and Safety of Fourth Administration of Boryung Cell-Culture Japanese Encephalitis Vaccineinj
A Phase 4 study testing Japanese encephalitis vaccine in people with Japanese Encephalitis, run by Boryung Pharmaceutical Co., Ltd at 9 sites in South Korea.
Trial summary
A multi-center, open, phase 4 clinical trial to assess the long-term immunogenicity and safety of fourth administration of Boryung Cell-Culture Japanese Encephalitis Vaccine inj. Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis
- What is being tested?
- Japanese encephalitis vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Aug 2015to Oct 2016
- Phase
- Phase 4
- 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 6 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent/guardian (legally authorized representative) has given voluntary written consent to the subject's participation after being fully informed of the purpose, methods, risks, and benefits of the study.
- Male and female children who have completed the primary 3 doses of JEV in the KD287-BR-CT-301study.
- Male and female children reaching at least 6 years of age on the day of booster dosing of JEV.
- Male and female children who are identified to be healthy based on physical examination and medical history.
Who cannot join
- Children who have acute febrile illness with tympanic temperature of ≥38.0 ℃ on the day of booster dosing of JEV.
- Children who have moderate or severe acute disease (regardless of fever).
- Children who have history of encephalitis, encephalopathy, cerebromeningitis, or convulsion.
- Children who have received JEV (including live JEV) other than the investigational products administered in the KD287-BR-CT-301study.
- Children who have had fever (≥ 40 °C) or systemic allergy within 48 hours after vaccination.
- Children who have shown anaphylactic reaction to the investigational products administered in the KD287-BR-CT-301study or who are likely to be allergic to the ingredients of the investigational product.
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- Children who have been diagnosed with immunodeficiency such as acquired immune deficiency or who have family history of immunodeficiency.
- Children who have received other vaccines within 28 days before booster dosing of JEV (vaccines to be administered according to the national vaccination program.
- Children who have received immunosuppressive thera-py within 28 days before booster dosing of JEV.
- There is a possibility that immune globulin preparations has not been excreted enough on the day of booster dosing of JEV if children have received such a product.
- Children who are currently participating or planning to participate in other clinical stud-ies during the study period.
- Other ineligible conditions judged at the discretion of principal investigators or subinvestigators.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do
Gachon University Gil Medical Center
Incheon
Inha University Hospital
Incheon
Ewha Womans University Mokdong Hospital
Seoul
Korea Cancer Center Hospital
Seoul
KyungHee University Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Wonju Sevrance Christian Hospital
Wŏnju, Gangwon-do
About this study
Official title: A Multi-center, Open, phase4 Study to Assess the Long-term Immunogenicity and Safety of Fourth Administration of BR JEV and to Investigate on Vaccine Interchangeability in Children Aged 6 Years Who Received 3 Doses With ENCEVAC or JEV-GCC
A multi-center, open, phase 4 clinical trial to assess the long-term immunogenicity and safety of fourth administration of Boryung Cell-Culture Japanese Encephalitis Vaccine inj. and to conduct an exploratory investigation on vaccine interchangeability in Korean children aged 6 years who received primary 3 doses with ENCEVAC® or Japanese Encephalitis Vaccine-GCC® inj.
Read the detailed description
This is a follow-up study of KD287-BR-CT-301 (ClinicalTrials.gov identifier: NCT01150942), a phase 3 study to investigate the efficacy and safety of a cell-culture Japanese encephalitis vaccine (ENCEVAC®) compared with that of a mouse brain-derived Japanese encephalitis vaccine (Japanese Encephalitis vaccine-GCC® inj). Subjects participated in KD287-BR-CT-301 study were to receive 3 doses of Japanese encephalitis vaccine (JEV) assigned by randomization from the age of 12 months and those subjects who completed the 3 doses of JEV are the target population in this study. The purpose of this study is to investigate the long-term immunogenicity and safety of the booster (fourth) dose of JEV, which will be given as Boryung Cell-Culture Japanese Encephalitis Vaccine inj, proven to be same with ENCEVAC® but manufactured by a different manufacturer.
- Conditions
- Japanese Encephalitis
- Being tested
- Japanese encephalitis vaccine
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Japanese encephalitis vaccineBiological
Also called Boryung Cell-Culture Japanese Encephalitis Vaccine
Dosage and administration: After reconstitution with 0.7 mL of the provided diluent, 0.5-mL dose is administered subcutaneously in the lateral aspect of the upper arm.
| Study group | Role | What they receive |
|---|---|---|
| Japanese encephalitis vaccine | Other | After reconstitution with 0.7 mL of the provided diluent, 0.5-mL dose,SC Receives: Biological: Japanese encephalitis vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the seroconversion rates before and after the fourth dose of JEV
Measured: Day 28 (28 days after booster dose)]
Secondary outcomes (4)
To assess the seropositive rates before and after the fourth dose of JEV
Measured: Day 28 (28 days after booster dose)]
To assess the geometric mean titer (GMT) before and after the fourth dose of JEV
Measured: Day 28 (28 days after booster dose)]
To assess the percentage of subjects who develop neutralizing antibody titers
Measured: Day 28 (28 days after booster dose)
To assess the percentage of subjects in their neutralizing anti-body titers
Measured: Day 28 (28 days after booster dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Japanese EncephalitisStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- HJ Jung, MD, Study director, Boryung Pharmaceutical Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532569
- Sponsor's protocol ID
- BR-KD-287-CT-401
- Acronym
- BR-JELITE
- Status last verified
- Feb 2017
- First submitted
- 21 Aug 2015
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yun KW, Lee HJ, Park JY, Cho HK, Kim YJ, Kim KH, Kim NH, Hong YJ, Kim DH, Kim HM, Cha SH. Long-term immunogenicity of an initial booster dose of an inactivated, Vero cell culture-derived Japanese encephalitis vaccine (JE-VC) and the safety and immunogenicity of a second JE-VC booster dose in children previously vaccinated with an inactivated, mouse brain-derived Japanese encephalitis vaccine. Vaccine. 2018 Mar 7;36(11):1398-1404. doi: 10.1016/j.vaccine.2018.01.075.
PubMed 29429815
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open, phase4 Study to Assess the Long-term Immunogenicity and Safety of Fourth Administration of BR JEV and to Investigate on Vaccine Interchangeability in Children Aged 6 Years Who Received 3 Doses With ENCEVAC or JEV-GCC
- ClinicalTrials.gov ID
- NCT02532569
- Acronym / sponsor ID
- BR-JELITE / BR-KD-287-CT-401
- Conditions
- Japanese Encephalitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Aug 2015 (estimated)
- 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.
A multi-center, open, phase 4 clinical trial to assess the long-term immunogenicity and safety of fourth administration of Boryung Cell-Culture Japanese Encephalitis Vaccine inj. and to conduct an exploratory investigation on vaccine interchangeability in Korean children aged 6 years who received primary 3 doses with ENCEVAC® or Japanese Encephalitis Vaccine-GCC® inj.
Detailed description
This is a follow-up study of KD287-BR-CT-301 (ClinicalTrials.gov identifier: NCT01150942), a phase 3 study to investigate the efficacy and safety of a cell-culture Japanese encephalitis vaccine (ENCEVAC®) compared with that of a mouse brain-derived Japanese encephalitis vaccine (Japanese Encephalitis vaccine-GCC® inj). Subjects participated in KD287-BR-CT-301 study were to receive 3 doses of Japanese encephalitis vaccine (JEV) assigned by randomization from the age of 12 months and those subjects who completed the 3 doses of JEV are the target population in this study. The purpose of this study is to investigate the long-term immunogenicity and safety of the booster (fourth) dose of JEV, which will be given as Boryung Cell-Culture Japanese Encephalitis Vaccine inj, proven to be same with ENCEVAC® but manufactured by a different manufacturer.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Japanese encephalitis vaccine | Other | Biological: Japanese encephalitis vaccineAfter reconstitution with 0.7 mL of the provided diluent, 0.5-mL dose,SC |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parent/guardian (legally authorized representative) has given voluntary written consent to the subject's participation after being fully informed of the purpose, methods, risks, and benefits of the study.
- Male and female children who have completed the primary 3 doses of JEV in the KD287-BR-CT-301study.
- Male and female children reaching at least 6 years of age on the day of booster dosing of JEV.
- Male and female children who are identified to be healthy based on physical examination and medical history.
Key exclusion criteria (12 listed)
- Children who have acute febrile illness with tympanic temperature of ≥38.0 ℃ on the day of booster dosing of JEV.
- Children who have moderate or severe acute disease (regardless of fever).
- Children who have history of encephalitis, encephalopathy, cerebromeningitis, or convulsion.
- Children who have received JEV (including live JEV) other than the investigational products administered in the KD287-BR-CT-301study.
- Children who have had fever (≥ 40 °C) or systemic allergy within 48 hours after 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 |
|---|---|---|
| Japanese encephalitis vaccineAlso: Boryung Cell-Culture Japanese Encephalitis VaccineDosage and administration: After reconstitution with 0.7 mL of the provided diluent, 0.5-mL dose is administered subcutaneously in the lateral aspect of the upper arm. | Biological | Japanese encephalitis vaccine |
Primary outcome
To assess the seroconversion rates before and after the fourth dose of JEV
Time frame: Day 28 (28 days after booster dose)]
4 secondary outcomes
To assess the seropositive rates before and after the fourth dose of JEV
Time frame: Day 28 (28 days after booster dose)]
To assess the geometric mean titer (GMT) before and after the fourth dose of JEV
Time frame: Day 28 (28 days after booster dose)]
To assess the percentage of subjects who develop neutralizing antibody titers
Time frame: Day 28 (28 days after booster dose)
To assess the percentage of subjects in their neutralizing anti-body titers
Time frame: Day 28 (28 days after booster dose)
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 6 Feb 2017.
- Derived from this study: PubMed 29429815Yun KW, Lee HJ, Park JY, Cho HK, Kim YJ, Kim KH, Kim NH, Hong YJ, Kim DH, Kim HM, Cha SH. Long-term immunogenicity of an initial booster dose of an inactivated, Vero cell culture-derived Japanese encephalitis vaccine (JE-VC) and the safety and immunogenicity of a second JE-VC booster dose in children previously vaccinated with an inactivated, mouse brain-derived Japanese encephalitis vaccine. Vaccine. 2018 Mar 7;36(11):1398-1404. doi: 10.1016/j.vaccine.2018.01.075.
- Individual participant dataSharing planned: No
Related trials for Japanese Encephalitis
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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 Jung, MD study director
Boryung Pharmaceutical Company
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Japanese encephalitis vaccine in people with Japanese Encephalitis, run by Boryung Pharmaceutical Co., Ltd at 9 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 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: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To assess the seroconversion rates before and after the fourth dose of JEV (time frame: Day 28 (28 days after booster dose)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02532569, which also lists 1 linked publication.
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 6 Feb 2017.