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Also known as High-Dose trivalent influenza vaccine, Fluzone
Standard Trivalent Influenza Vaccine · 2 trials · 3 indications
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage.
Anti-influenza antibodies will be measured using HAI assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage. Seroconversion status 28 days after vaccination (ie, preinjection Ab titer \< 10 \[1/dil\] at Day 1 and post-injection Ab titer≥ 40 \[1/dil\] at Day 29 or preinjection Ab titer ≥ 10 \[1/dil\] at Day 1 and a ≥ 4-fold increase in titer \[1/dil\] at Day 29).
Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.
| Arm | Type | Description |
|---|---|---|
| IIV-HD | EXPERIMENTAL | Participants will receive a single intramuscular (IM) injection of IIV-HD at Day 1 |
| IIV-SD | ACTIVE_COMPARATOR | Participants will receive a single intramuscular (IM) injection of IIV-SD at Day 1 |
| High-Dose Influenza Vaccine | EXPERIMENTAL | - |
| Standard Trivalent Influenza Vaccine | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| High-Dose trivalent influenza vaccine (Split virion, Inactivated) | BIOLOGICAL | Liquid suspension for intramuscular injection |
| Standard-dose trivalent influenza vaccine (Split virion, Inactivated) | BIOLOGICAL | Liquid suspension for intramuscular injection |
| Standard Trivalent Influenza Vaccine | BIOLOGICAL | Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient. |
| High-Dose Influenza Vaccine | BIOLOGICAL | Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient. |
Inclusion Criteria: * Aged 50 to 64 years on the day of inclusion. * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * Is of non-childbearing potential. To be considered of non-childbearing potential, a female m...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE2 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4117, AZD5315 |
| 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 |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE1 | Cell-based Trivalent Split Influenza Virus Vaccine, Egg-based Trivalent Split Influenza Virus Vaccine |
High-Dose trivalent influenza vaccine is an inactivated, split virion influenza vaccine developed by Sanofi. It is studied for prevention of influenza, including in adults aged 50 through 64 years and in cancer patients receiving chemotherapy. It is also known as Standard Trivalent Influenza Vaccine and High-Dose trivalent influenza vaccine (Split virion, Inactivated).
High-Dose trivalent influenza vaccine has been studied in cancer patients younger than 65 years who are receiving chemotherapy, to assess influenza vaccination in that population. A completed Phase 2 trial, NCT01666782, compared the high-dose vaccine with a standard vaccine in 105 participants with cancer and influenza viral infections.
High-Dose trivalent influenza vaccine is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor associated with the clinical development program for this inactivated, split virion trivalent influenza vaccine.
High-Dose trivalent influenza vaccine is in clinical development, with completed Phase 2 and Phase 3 studies. It is investigational. A Phase 3 trial, NCT06641180, evaluated immunogenicity and safety in adults 50 through 64 years of age and has been completed.
Two completed trials are registered for High-Dose trivalent influenza vaccine. NCT06641180 was a Phase 3 immunogenicity and safety study in adults 50 through 64 years of age in the United States, enrolling 1,180 participants. NCT01666782 was a Phase 2 comparison with standard vaccine in cancer patients under 65 receiving chemotherapy, enrolling 105.
High-Dose trivalent influenza vaccine is also known as Standard Trivalent Influenza Vaccine and as High-Dose trivalent influenza vaccine (Split virion, Inactivated). These names refer to the same Sanofi trivalent influenza vaccine asset described in its clinical development program.