BR-JELITE: Long-term Immunogenicity and Safety of Fourth Administration of Boryung Cell-Culture Japanese Encephalitis Vaccineinj
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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 Names:
|
Outcome Measures
Primary Outcome Measures
- To assess the seroconversion rates before and after the fourth dose of JEV [Day 28 (28 days after booster dose)]]
Secondary Outcome Measures
- 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)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Male and female children who have completed the primary 3 doses of JEV in the KD287-BR-CT-301study.
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Male and female children reaching at least 6 years of age on the day of booster dosing of JEV.
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Male and female children who are identified to be healthy based on physical examination and medical history.
Exclusion Criteria:
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Children who have acute febrile illness with tympanic temperature of ≥38.0 ℃ on the day of booster dosing of JEV.
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Children who have moderate or severe acute disease (regardless of fever).
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Children who have history of encephalitis, encephalopathy, cerebromeningitis, or convulsion.
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Children who have received JEV (including live JEV) other than the investigational products administered in the KD287-BR-CT-301study.
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Children who have had fever (≥ 40 °C) or systemic allergy within 48 hours after vaccination.
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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.
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Children who have received other vaccines within 28 days before booster dosing of JEV (vaccines to be administered according to the national vaccination program.
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Children who have received immunosuppressive thera-py within 28 days before booster dosing of JEV.
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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.
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Children who are currently participating or planning to participate in other clinical stud-ies during the study period.
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Other ineligible conditions judged at the discretion of principal investigators or subinvestigators.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wonju Sevrance Christian Hospital | Wonju | Gangwon-do | Korea, Republic of | |
| 2 | Inje University Ilsan Paik Hospital | Goyang | GyeongGi-Do | Korea, Republic of | |
| 3 | Gachon University Gil Medical Center | Incheon | Korea, Republic of | ||
| 4 | Inha University Hospital | Incheon | Korea, Republic of | ||
| 5 | Ewha Womans University Mokdong Hospital | Seoul | Korea, Republic of | ||
| 6 | Korea Cancer Center Hospital | Seoul | Korea, Republic of | ||
| 7 | KyungHee University Hospital | Seoul | Korea, Republic of | ||
| 8 | Samsung Medical Center | Seoul | Korea, Republic of | ||
| 9 | Seoul National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Boryung Pharmaceutical Co., Ltd
Investigators
- Study Director: HJ Jung, MD, Boryung Pharmaceutical Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BR-KD-287-CT-401