Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative · 1 trial · 1 indication
Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
| Arm | Type | Description |
|---|---|---|
| Group 1: Investigational Quadrivalent Influenza Vaccine | EXPERIMENTAL | Participants will receive a dose of Investigational Quadrivalent Inactivated Influenza Vaccine |
| Group 2: Investigational Trivalent Influenza Vaccine | EXPERIMENTAL | Participants will receive a dose of Investigational Trivalent Inactivated Influenza Vaccine |
| Group 3: Licensed 2010-2011 Trivalent Influenza Vaccine | ACTIVE_COMPARATOR | Participants will receive a dose of Licensed 2010-2011 Trivalent Inactivated Influenza Vaccine |
| Group 4: Licensed 2010-2011 Trivalent Influenza Vaccine | ACTIVE_COMPARATOR | Participants will receive a dose of Licensed 2010-2011 Trivalent Inactivated Influenza Vaccine |
| Name | Type | Description |
|---|---|---|
| Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative | BIOLOGICAL | 0.5 mL, Intramuscular |
| Investigational Trivalent Inactivated Influenza Vaccine, No Preservative | BIOLOGICAL | 0.5 mL, Intramuscular |
| Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion criteria: * Subject is 18 years of age or older on the day of inclusion. * Informed consent form (ICF) has been signed and dated. * Able to attend all scheduled visits and to comply with all trial procedures. * For a woman of childbearing potential, use of an effective method of contracep...