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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00554333 | Comparative Study of Immunogenicity and Safety of Flu-ID Vaccine Versus Flu-IM Vaccine | PHASE3 | COMPLETED | 795 | — | — | Oct 1, 2007 | Dec 1, 2007 | Mar 16, 2018 | 8 | Belgium, France |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Inactivated Split-Virion Influenza Vaccine for Intradermal Route |
| 2 | ACTIVE_COMPARATOR | Inactivated adjuvanted Influenza Vaccine for Intramuscular Route |
| Name | Type | Description |
|---|---|---|
| Flu-ID 15μg | BIOLOGICAL | Inactivated Split-Virion Influenza Vaccine for Intradermal Route |
| Inactivated adjuvanted Influenza Vaccine | BIOLOGICAL | Inactivated adjuvanted Influenza Vaccine for Intramuscular Route |
Inclusion Criteria: * Aged 65 years or older on the day of inclusion Exclusion Criteria: * Febrile illness (oral temperature ≥37.5°C) on the day of inclusion * Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination * Unstable chronic illness * Congenital or acquired immu...