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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
94
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.
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
To assess the seroconversion rates before and after the fourth dose of JEV
Time frame: Day 28 (28 days after booster dose)]
To assess the seropositive rates before and after the fourth dose of JEV
Time frame: Day 28 (28 days after booster dose)]
To assess the geometric mean titer (GMT) before and after the fourth dose of JEV
Time frame: Day 28 (28 days after booster dose)]
To assess the percentage of subjects who develop neutralizing antibody titers
Time frame: Day 28 (28 days after booster dose)
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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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