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Long-term Immunogenicity and Safety of Fourth Administration of Boryung Cell-Culture Japanese Encephalitis Vaccineinj (BR-JELITE)

Primary Purpose

Japanese Encephalitis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Japanese encephalitis vaccine
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Japanese Encephalitis

Eligibility Criteria

6 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Wonju Sevrance Christian Hospital
  • Inje University Ilsan Paik Hospital
  • Gachon University Gil Medical Center
  • Inha University Hospital
  • Ewha Womans University Mokdong Hospital
  • Korea Cancer Center Hospital
  • KyungHee University Hospital
  • Samsung Medical Center
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Japanese encephalitis vaccine

Arm Description

After reconstitution with 0.7 mL of the provided diluent, 0.5-mL dose,SC

Outcomes

Primary Outcome Measures

To assess the seroconversion rates before and after the fourth dose of JEV

Secondary Outcome Measures

To assess the seropositive rates before and after the fourth dose of JEV
To assess the geometric mean titer (GMT) before and after the fourth dose of JEV
To assess the percentage of subjects who develop neutralizing antibody titers
To assess the percentage of subjects in their neutralizing anti-body titers

Full Information

First Posted
August 21, 2015
Last Updated
February 3, 2017
Sponsor
Boryung Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02532569
Brief Title
Long-term Immunogenicity and Safety of Fourth Administration of Boryung Cell-Culture Japanese Encephalitis Vaccineinj
Acronym
BR-JELITE
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Encephalitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Japanese encephalitis vaccine
Arm Type
Other
Arm Description
After reconstitution with 0.7 mL of the provided diluent, 0.5-mL dose,SC
Intervention Type
Biological
Intervention Name(s)
Japanese encephalitis vaccine
Other Intervention Name(s)
Boryung Cell-Culture Japanese Encephalitis Vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the seroconversion rates before and after the fourth dose of JEV
Time Frame
Day 28 (28 days after booster dose)]
Secondary Outcome Measure Information:
Title
To assess the seropositive rates before and after the fourth dose of JEV
Time Frame
Day 28 (28 days after booster dose)]
Title
To assess the geometric mean titer (GMT) before and after the fourth dose of JEV
Time Frame
Day 28 (28 days after booster dose)]
Title
To assess the percentage of subjects who develop neutralizing antibody titers
Time Frame
Day 28 (28 days after booster dose)
Title
To assess the percentage of subjects in their neutralizing anti-body titers
Time Frame
Day 28 (28 days after booster dose)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HJ Jung, MD
Organizational Affiliation
Boryung Pharmaceutical Company
Official's Role
Study Director
Facility Information:
Facility Name
Wonju Sevrance Christian Hospital
City
Wonju
State/Province
Gangwon-do
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Goyang
State/Province
GyeongGi-Do
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea Cancer Center Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
KyungHee University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29429815
Citation
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.
Results Reference
derived

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Long-term Immunogenicity and Safety of Fourth Administration of Boryung Cell-Culture Japanese Encephalitis Vaccineinj

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