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

NCT ID: NCT02532569

Last Updated: 2017-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-10-31

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.

Conditions

Japanese Encephalitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Japanese encephalitis vaccine

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

Group Type: OTHER

Japanese encephalitis vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Boryung Cell-Culture Japanese Encephalitis Vaccine

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

HJ Jung, MD

Role: STUDY_DIRECTOR

Boryung Pharmaceutical Company

Locations

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

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 29429815 (View on PubMed)

Other Identifiers

BR-KD-287-CT-401

Identifier Type: -

Identifier Source: org_study_id