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

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ClinicalTrials.gov Identifier: NCT02532569
Recruitment Status : Completed
First Posted : August 26, 2015
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Biological: Japanese encephalitis vaccine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Prevention
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 Start Date : August 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis

Arm Intervention/treatment
Japanese encephalitis vaccine
After reconstitution with 0.7 mL of the provided diluent, 0.5-mL dose,SC
Biological: 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.
Other Name: Boryung Cell-Culture Japanese Encephalitis Vaccine




Primary Outcome Measures :
  1. To assess the seroconversion rates before and after the fourth dose of JEV [ Time Frame: Day 28 (28 days after booster dose)] ]

Secondary Outcome Measures :
  1. To assess the seropositive rates before and after the fourth dose of JEV [ Time Frame: Day 28 (28 days after booster dose)] ]
  2. To assess the geometric mean titer (GMT) before and after the fourth dose of JEV [ Time Frame: Day 28 (28 days after booster dose)] ]
  3. To assess the percentage of subjects who develop neutralizing antibody titers [ Time Frame: Day 28 (28 days after booster dose) ]
  4. To assess the percentage of subjects in their neutralizing anti-body titers [ Time Frame: Day 28 (28 days after booster dose) ]


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Ages Eligible for Study:   6 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02532569


Locations
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Korea, Republic of
Wonju Sevrance Christian Hospital
Wonju, Gangwon-do, Korea, Republic of
Inje University Ilsan Paik Hospital
Goyang, GyeongGi-Do, Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
Korea Cancer Center Hospital
Seoul, Korea, Republic of
KyungHee University Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
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Study Director: HJ Jung, MD Boryung Pharmaceutical Company

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT02532569     History of Changes
Other Study ID Numbers: BR-KD-287-CT-401
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Encephalitis, Japanese
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs