Clinical trial NCT02532569: Long-term Immunogenicity and Safety of Fourth Administration of Boryung Cell-Culture Japanese Encephalitis Vaccineinj
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Japanese Encephalitis
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2015-08-26
Enrollment: 94
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: To assess the seroconversion rates before and after the fourth dose of JEV
timeFrame: Day 28 (28 days after booster dose)]
Secondary outcomes:
measure: To assess the seropositive rates before and after the fourth dose of JEV
timeFrame: Day 28 (28 days after booster dose)]
measure: To assess the geometric mean titer (GMT) before and after the fourth dose of JEV
timeFrame: Day 28 (28 days after booster dose)]
measure: To assess the percentage of subjects who develop neutralizing antibody titers
timeFrame: Day 28 (28 days after booster dose)
measure: To assess the percentage of subjects in their neutralizing anti-body titers
timeFrame: Day 28 (28 days after booster dose)
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Sevrance Christian Hospital
state: Gangwon-do
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: GyeongGi-Do
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Boryung Pharmaceutical Company
name: HJ Jung, MD
role: STUDY_DIRECTOR
References:
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.