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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00606359 | Immunogenicity of the Inactivated Split-Virion Influenza Vaccine in Renal Transplant Subjects | PHASE2 | COMPLETED | 62 | — | — | Nov 1, 2007 | Jun 1, 2008 | Jan 14, 2014 | 1 | France |
| NCT00776438 | Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines | PHASE2 | COMPLETED | 160 | — | — | Sep 1, 2007 | Apr 1, 2009 | Jun 17, 2015 | 1 | France |
| NCT00524940 | Trial to Describe the Safety and Immunogenicity of Fluzone® | PHASE2 | COMPLETED | 124 | — | — | Aug 1, 2007 | Dec 1, 2007 | Apr 14, 2016 | 1 | United States |
| NCT00703651 | Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults | PHASE2 | COMPLETED | 1,150 | — | — | Sep 1, 2003 | Jul 1, 2006 | Jan 13, 2014 | 8 | Belgium, Czechia +1 |
Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.
GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation.
| Arm | Type | Description |
|---|---|---|
| Study Group 1 | EXPERIMENTAL | - |
| Study Group 2 | ACTIVE_COMPARATOR | - |
| Study Group 3 | EXPERIMENTAL | Elderly, age 60 to 85 years |
| Study Group 4 | EXPERIMENTAL | Elderly, age 60 to 85 years |
| Study Group | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Inactivated, split-virion influenza virus | BIOLOGICAL | 0.1 mL, Intradermal. 2 vaccinations 12 months apart |
| Inactivated, split-virion, influenza vaccine | BIOLOGICAL | 0.1 mL, Intradermal |
| Inactivated, split-virion influenza vaccine | BIOLOGICAL | 0.1 mL, Intradermal |
Inclusion Criteria: * Able to attend all scheduled visits and to comply with all trial procedures. * Subject with renal transplant for at least 6 months. * Subject with stable renal function, i.e. with a variation of creatinin value \< 20% and with a creatinin clearance estimated according to Cockr...