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Also known as Influenza virus vaccine - cell based (2007-2008 Formulation)
Influenza virus vaccine- cell based · 1 trial · 3 indications
Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)
Seroconversion: For participants with a Day 0 pre-vaccination titer \< 10 (1/dil), titer ≥ 40 (1/dil) on Day 21. Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21.
| Arm | Type | Description |
|---|---|---|
| Group 1: Standard-dose Cell-based Influenza Vaccine | EXPERIMENTAL | Participants will receive a single dose of standard-dose cell-based influenza virus vaccine. |
| Group 2: High-dose Cell-based Influenza Vaccine | EXPERIMENTAL | Participants will receive a single dose of high-dose cell-based influenza virus vaccine. |
| Group 3: Licensed Fluzone® Influenza Vaccine | ACTIVE_COMPARATOR | Participants will receive a single dose of licensed Fluzone® influenza vaccine. |
| Name | Type | Description |
|---|---|---|
| Influenza virus vaccine - cell based (2007-2008 Formulation) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Influenza virus vaccine - cell-based (2007-2008 Formulation) | BIOLOGICAL | 1.0 mL, Intramuscular |
| Influenza virus vaccine (2007-2008 Formulation) | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria : * Healthy male or female subject, aged ≥ 18 to \< 50 years on the day of inclusion * Informed consent form signed * Able to attend all scheduled visits and to comply with all trial procedures * For a woman of childbearing potential: a negative urine pregnancy test and documente...