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...
Top 6 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 1 | PHASE3 | mRNA-1018-H5 |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | Flu/COVID-19 mRNA combination vaccine |
It is an investigational trivalent influenza vaccine developed by Sanofi that contains an alternate B strain and no preservative. It is designed to protect against influenza and was studied in a Phase 3 clinical trial. It is not described as approved and remains an investigational vaccine candidate.
Sanofi develops this investigational trivalent influenza vaccine. Sanofi trades on the New York Stock Exchange under the ticker SNY. The vaccine is part of Sanofi's influenza vaccine development work and was evaluated in a completed Phase 3 study among children.
It is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The completed study, NCT01240746, was a randomized, double-blind, active-controlled trial that enrolled 4,363 children aged 6 months and older in the United States.
It was studied in the Phase 3 trial NCT01240746, titled Study of Quadrivalent Influenza Vaccine Among Children. That trial enrolled 4,363 participants, was randomized, double-blind, and active-controlled, and has been completed. Participants were healthy volunteers aged 6 months and older in the United States.
It is being developed for the prevention of influenza. The completed Phase 3 trial enrolled 4,363 children aged 6 months and older in the United States. The vaccine candidate contains an alternate B strain and is formulated without preservative.