Prevention of Japanese encephalitis
Conditions
Interventions
Primary vaccination series: Subcutaneously or intramuscularly inject KD6-287 0.5 mL twice at an interval of 7-28 days (for children below 3 years of age, 0.25 mL per dose)
Booster dose: Subcutaneously
Sponsors
Horita Akira
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy infants and children who can receive investigational products three times from 6 to <90 months of age (2) Written informed consent by a legally acceptable representative
Exclusion criteria
Exclusion criteria: (1) Has a history of Japanese encephalitis (2) Has a history of immunization against Japanese encephalitis (3) Has a known history of anaphylaxis caused by ingredients of the investigational products (4) Presence of fibrodysplasia ossificans progressiva (5) Has participated in a clinical study and received other investigational products within 4 months (120 days) before the first dose or plans to participate in other clinical study during this study (6) Has received blood transfusion or gamma globulin preparation within 3 months (90 days) before the first dose or massive-dose gamma globulin therapy (>= 200 mg/kg) within 6 months (180 days) before the first dose (7) Has received treatment that may affect the immune function* within 6 months (180 days) before the first dose *Radiotherapy, immunosuppressive drugs (external use is allowed), immunosuppressive therapy, antirheumatic drugs, adrenocorticotropic hormone, corticosteroids (>= 2 mg/kg/day of prednisolone equivalent for 14 days or longer, external use is allowed) (8) Is ineligible for other reasons in the investigator (sub-investigator)'s opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion rate of neutralizing antibodies after the third dose | — |
Secondary
| Measure | Time frame |
|---|---|
| -Mean neutralizing antibody titer (log10) after the third dose -Seroconversion rate of neutralizing antibodies after the second dose -Mean neutralizing antibody titer (log10) after the second dose | — |
Contacts
Public ContactMasatoshi Yamashita
KM Biologics Co., Ltd.
Outcome results
None listed