Long-term Immunogenicity and Safety of Fourth Administration of Boryung Cell-Culture Japanese Encephalitis Vaccineinj
BR-JELITE
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
1 other identifier
interventional
94
1 country
9
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2015
9 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
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 21, 2015
CompletedFirst Posted
Study publicly available on registry
August 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFebruary 6, 2017
February 1, 2017
1.2 years
August 21, 2015
February 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the seroconversion rates before and after the fourth dose of JEV
Day 28 (28 days after booster dose)]
Secondary Outcomes (4)
To assess the seropositive rates before and after the fourth dose of JEV
Day 28 (28 days after booster dose)]
To assess the geometric mean titer (GMT) before and after the fourth dose of JEV
Day 28 (28 days after booster dose)]
To assess the percentage of subjects who develop neutralizing antibody titers
Day 28 (28 days after booster dose)
To assess the percentage of subjects in their neutralizing anti-body titers
Day 28 (28 days after booster dose)
Study Arms (1)
Japanese encephalitis vaccine
OTHERAfter reconstitution with 0.7 mL of the provided diluent, 0.5-mL dose,SC
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Wonju Sevrance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Korea Cancer Center Hospital
Seoul, South Korea
KyungHee University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 29429815DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
HJ Jung, MD
Boryung Pharmaceutical Company
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open Label
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2015
First Posted
August 26, 2015
Study Start
August 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
February 6, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share