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Split, Inactivated, Trivalent Influenza Vaccine · 3 trials · 3 indications
Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.
Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer \< 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination.
Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40
| Arm | Type | Description |
|---|---|---|
| Influenza Virus Vaccine Formulation 1 | EXPERIMENTAL | Influenza Virus Vaccine Formulation 1 |
| Influenza Virus Vaccine Formulation 2 | EXPERIMENTAL | Influenza Virus Vaccine Formulation 2 |
| Fluzone® Elderly Group | ACTIVE_COMPARATOR | - |
| Fluzone® High-dose Group | ACTIVE_COMPARATOR | Participants enrolled at age ≥ 65 years |
| Fluzone® Adults Group | ACTIVE_COMPARATOR | Participants enrolled at age 18-49 years. |
| 1 | EXPERIMENTAL | Split, Inactivated, Trivalent Influenza Vaccine |
| 2 | EXPERIMENTAL | Split, Inactivated, Trivalent Influenza Vaccine |
| 3 | ACTIVE_COMPARATOR | Split, Inactivated, Trivalent Influenza Vaccine |
| 4 | ACTIVE_COMPARATOR | Split, Inactivated, Trivalent Influenza Vaccine |
| Fluzone Intradermal (ID) Vaccine Group | EXPERIMENTAL | Participants received a dose of Fluzone Intradermal (ID) Influenza Vaccine |
| Fluzone Intramuscular (IM) Vaccine Group | ACTIVE_COMPARATOR | Participants received a dose of Fluzone Intramuscular (IM) Influenza Vaccine. |
| Name | Type | Description |
|---|---|---|
| Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1) | BIOLOGICAL | 0.1 mL, Intradermal (ID) |
| Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2) | BIOLOGICAL | 0.1 mL, Intradermal (ID) |
| Split, Inactivated, Trivalent Influenza Vaccine (Standard dose) | BIOLOGICAL | 0.5 mL, Intramuscular (IM) |
| Split, Inactivated, Trivalent Influenza Vaccine (High-dose) | BIOLOGICAL | 0.5 mL, Intramuscular (IM) |
| Split, Inactivated, Trivalent Influenza Vaccine | BIOLOGICAL | Vaccine (infant dose) |
| Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) | BIOLOGICAL | Vaccine (infant dose) |
Inclusion Criteria: * Aged ≥ 65 years or aged 18 to 49 years on the day of vaccination. * Informed consent form signed. * Medically stable (Subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as their symptoms/signs are controlled...
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 |
Split, Inactivated, Trivalent Influenza Vaccine is an investigational vaccine developed by Sanofi for the prevention of influenza and Orthomyxoviridae infection. It is a split, inactivated, trivalent formulation, meaning it contains three influenza virus strains that have been chemically disrupted. It is being studied in both adult and pediatric populations.
Split, Inactivated, Trivalent Influenza Vaccine is being developed for the prevention of influenza and Orthomyxoviridae infection. It is intended to protect against three influenza virus strains. The vaccine is in Phase 2 clinical development and has been studied in adults, the elderly, and children.
Split, Inactivated, Trivalent Influenza Vaccine is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical trials evaluating this vaccine candidate.
Split, Inactivated, Trivalent Influenza Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 2 trials have been completed.
Split, Inactivated, Trivalent Influenza Vaccine has been evaluated in two completed Phase 2 trials. NCT00551031 studied the vaccine in adult and elderly subjects, and NCT00391391 studied it in infants and children. Both trials were randomized, double-blind, and active-controlled, with a combined enrollment of 2,098 participants.