Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Investigational Trivalent Influenza Vaccine with alternate B strain, 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.
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: Licensed 2010-2011 TIV | ACTIVE_COMPARATOR | Participants will receive the Licensed 2010-2011 Trivalent Influenza Vaccine containing the primary B strain. |
| Group 2: Investigational TIV | EXPERIMENTAL | Participants will receive the Investigational Trivalent Influenza Vaccine containing the alternate B strain |
| Group 3: Investigational QIV | EXPERIMENTAL | Participants will receive the investigational Quadrivalent Influenza Vaccine |
| Name | Type | Description |
|---|---|---|
| Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative | BIOLOGICAL | 0.25 mL (6 to 35 months) or 0.5 mL (3 to \<9 years), Intramuscular |
| Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative | BIOLOGICAL | 0.25 mL (6 to 35 months) or 0.5 mL (3 to \<9 years), Intramuscular |
| Quadrivalent Influenza Vaccine, No Preservative | BIOLOGICAL | 0.25 mL (6 to 35 months), or 0.5 mL(3 to \<9 years), Intramuscular |
Inclusion Criteria: * Subject is 6 months to \< 9 years of age on the day of inclusion. * Parent/guardian is willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study. * Subject is in reasonably good health as assessed by the Investi...