This is a randomized, open-label Phase 3 study including children aged \>9 months to \<17 years and 7 months who have been vaccinated with IXIARO in study IC51-323.
This is a randomized, open-label Phase 3 study including children aged \>9 months to \<17 years and 7 months who have been vaccinated with IXIARO in the previous study IC51-323.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
Research Institute for Tropical Medicine - Clinical Research Division
City of Muntinlupa, Alabang, Philippines
Research Institute for Tropical Medicine
City of Muntinlupa, Alabang, Philippines
UP-Philippine General Hospital
Manila, Manila, Philippines
SCRs (Seroconversion Rate) as Defined by Percentage of Subjects With Plaque Reduction Neutralization Test Titers of>1:10 at 1 Month After the Booster Dose
Time frame: 1 month post booster
Rate of Subjects Achieving a >4-fold Increase in JEV (Japanese Encephalitis Virus) Neutralizing Antibody Titers at 1 Month After the Booster Dose
Time frame: 1 month
GMTs (Geometric Mean Titre) for JEV Neutralizing Antibodies Measured Using a Validated PRNT (Plaque Reduction Neutralization Test) at 1 Month After the Booster Dose
Time frame: 1 month
GMTs and Rate of Subjects With a PRNT Titer of >1:10 at Months 12, 24 and 36 After First IXIARO Vaccination in IC51-323 With and Without Booster Vaccination
Time frame: 36 months
Rate of Subjects With SAEs (Serious Adverse Events) Following Immunization and Medically Attended AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and
Time frame: 36 months
Rate of Subjects With Unsolicited AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and Relationship to Vaccinations.
Time frame: 36 months
Rate of Subjects With SAEs and Medically Attended AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations.
Time frame: 1 month
Rate of Subjects With Unsolicited AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations.
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Time frame: 1 month
Rate of Subjects With Solicited AEs for up to 7 Days Following the Booster Dose. Severity and Duration.
Time frame: 7 days