Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01041573 | Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population | PHASE3 | COMPLETED | 1,869 | — | — | Mar 1, 2010 | Jul 1, 2011 | Jul 27, 2021 | 2 | Philippines |
Rate of subjects with these types of AEs, comparison vs respective control vaccine stratified by age group: All study participants aged \< 1 year: IC51 0.25mL vs. Prevnar; All study participants aged 1 year and above: IC51 0.25 mL or =.5 mL vs. Havrix.
| Arm | Type | Description |
|---|---|---|
| IC51 0.5 mL | EXPERIMENTAL | Japanese Encephalitis Vaccine 6mcg im. at day 0 and day 28 |
| IC51 0.25 mL | EXPERIMENTAL | Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28 |
| Havrix 720 | ACTIVE_COMPARATOR | Havrix®720 0.5 ml im. at day 0 and month 7 |
| Prevnar | ACTIVE_COMPARATOR | Prevnar 0.5 ml im. at day 0 and day 56 and month 7 or 0.5 ml im. at day 0, day 28 and day56 and month 7-13 |
| Name | Type | Description |
|---|---|---|
| IC51 Japanese Encephalitis | BIOLOGICAL | 6 mcg or 3 mcg im. at day 0 and day 28 |
| Havrix®720 | BIOLOGICAL | 0.5 ml im. at day 0 and month 7 |
| Prevnar | BIOLOGICAL | 0.5 ml im. at day 0 and day 56 and month 7 |
Inclusion Criteria: * Male or female healthy children and adolescents aged \> 2 months to \< 18 years at the time of first vaccination. * Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable. * ...