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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00630331 | Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects | PHASE3 | COMPLETED | 11,404 | — | — | Oct 1, 2007 | Jul 1, 2008 | May 24, 2024 | 56 | United States, Finland +1 |
| NCT00306527 | Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly | PHASE3 | COMPLETED | 2,235 | — | — | Sep 1, 2005 | Apr 1, 2006 | Aug 14, 2019 | 5 | Poland |
The vaccine efficacy of CCI and IVV vaccines was estimated relative to Placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza illness caused by each of three vaccine-like virus strains.
To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine .
| Arm | Type | Description |
|---|---|---|
| CCI | EXPERIMENTAL | Subjects received one dose of cell culture-derived influenza vaccine. |
| IVV | EXPERIMENTAL | Subjects received one dose of the trivalent egg-derived influenza vaccine. |
| Placebo | PLACEBO_COMPARATOR | Subjects received one dose of phosphate buffered solution (PBS). |
| cTIV\cTIV (adults) | ACTIVE_COMPARATOR | Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study. |
| cTIV\TIV (adults) | ACTIVE_COMPARATOR | Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
| cTIV\cTIV (elderly) | ACTIVE_COMPARATOR | Subjects (≥61 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study. |
| cTIV\TIV (elderly) | ACTIVE_COMPARATOR | Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
| TIV\TIV (adults) | ACTIVE_COMPARATOR | Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
| TIV\cTIV (adults) | ACTIVE_COMPARATOR | Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study. |
| TIV\TIV (elderly) | ACTIVE_COMPARATOR | Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
| TIV\cTIV (elderly) | ACTIVE_COMPARATOR | Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study. |
| Name | Type | Description |
|---|---|---|
| Cell culture-derived influenza vaccine | BIOLOGICAL | One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle. |
| Egg-derived influenza virus vaccine | BIOLOGICAL | One dose (0.5 mL) of the trivalent egg-derived influenza virus vaccine, administered in the deltoid muscle. |
| Placebo | BIOLOGICAL | One dose (0.5 mL) of phosphate buffered solution. |
| Cell culture derived influenza vaccine | BIOLOGICAL | as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm |
| egg-derived influenza subunit vaccine | BIOLOGICAL | as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm |
Inclusion Criteria: 1. subjects 18 to 49 years of age; 2. in good health as determined by medical history and physical examination; 3. able and willing to provide written informed consent prior to any study procedure; 4. able to comply with all study procedures, including availability and willingne...