Japanese Encephalitis
Conditions
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.
Interventions
BIOLOGICALJapanese 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.
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
6 Years to 7 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the seroconversion rates before and after the fourth dose of JEV | Day 28 (28 days after booster dose)] |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
Countries
South Korea
Outcome results
None listed