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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00579345 | Second Extension Study to Evaluate Safety and Tolerability of Influenza Vaccines in Adults and Elderly, and to Evaluate Immunogenicity and Concomitant Vaccination With Pneumococcal Vaccine in a Subgroup | PHASE3 | COMPLETED | 1,522 | — | — | Oct 1, 2007 | Jun 1, 2008 | Jan 27, 2017 | 5 | Poland |
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site.
Non-inferiority of the influenza vaccine FLU (cell-culture derived seasonal trivalent influenza vaccine (cTIV); and influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a)) when administered alone versus administered concomitantly with pneumococcal vaccine (FLU + PV) is met if lower limit of the 2-sided 95% confidence interval (CI) of postvaccination (Day 22) Geometric Mean Titer ratio (FLU+PV/FLU) is greater than 0.5.
| Arm | Type | Description |
|---|---|---|
| cTIV | EXPERIMENTAL | Cell culture derived seasonal trivalent influenza vaccine (cTIV) |
| eTIV_a | ACTIVE_COMPARATOR | Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) |
| FLU (cTIV or eTIV_a) | EXPERIMENTAL | Cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a). |
| FLU (cTIV or eTIV_a) + PV | ACTIVE_COMPARATOR | 23-valent Pneumococcal vaccine (PV) concomitantly administered with cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a). |
| Name | Type | Description |
|---|---|---|
| Cell culture derived seasonal trivalent influenza vaccine (cTIV) | BIOLOGICAL | cell cultured trivalent influenza vaccine (cTIV) vaccine administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm. |
| Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a). | BIOLOGICAL | egg based trivalent influenza vaccine (eTIV\_a) administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm. |
| cTIV or eTIV_a | BIOLOGICAL | 0.5 mL, Single dose of either cell cultured trivalent influenza vaccine (cTIV) or egg based trivalent influenza vaccine eTIV\_a administered. |
| cTIV+PV OR eTIV_a+PV | BIOLOGICAL | 0.5 mL, Single dose of either cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) administered concomitantly with 23-valent pneumococcal polysaccharide vaccine (PV). |
Inclusion Criteria: * participation in the V58P4 study * mentally competent to understand the nature, the scope and the consequences of the study * able and willing to give written informed consent prior to study entry * available for all the visits scheduled in the study Exclusion Criteria: * re...