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Also known as Inactivated, split-virion influenza vaccine, Inactivated, split-virion, influenza vaccine, High-Dose Inactivated, Split-Virion Influenza Vaccine
Inactivated, Split-Virion Influenza Virus · 8 trials · 5 indications
Antibodies against each of three Influenza antigens (virus) in Fluzone® High-Dose and Standard Fluzone® vaccines (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) were determined by the Hemagglutination inhibition assay method.
Seroconversion was defined as a Hemagglutination Inhibition Antibody Titers of Titer ≥40 (1/dil) on Day 28 if pre-vaccination (Day 0) titer \<10 (1/dil); or a four-fold increase of titer on Day 28, if pre-vaccination (Day 0) titer is ≥10 (1/dil) for each of the three Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia).
Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.
GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation.
| Arm | Type | Description |
|---|---|---|
| Study Group 1 | EXPERIMENTAL | Participants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 |
| Study Group 2 | EXPERIMENTAL | Participants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 |
| Study Group 3 | EXPERIMENTAL | Participants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 |
| Group 4 | ACTIVE_COMPARATOR | Participants will receive the Standard Fluzone® vaccine |
| Study Group 4 | EXPERIMENTAL | Elderly, age 60 to 85 years |
| Study Group | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| 3 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| High-Dose Inactivated, Split-Virion Influenza Vaccine | BIOLOGICAL | 0.5 mL, IM |
| Inactivated, Split-Virion Influenza Vaccine | BIOLOGICAL | 0.5 mL, IM |
| Inactivated, split-virion influenza virus | BIOLOGICAL | 0.1 mL, Intradermal. 2 vaccinations 12 months apart |
| Inactivated, split-virion, influenza vaccine | BIOLOGICAL | 0.1 mL, Intradermal |
| Inactivated, split-virion, influenza virus | BIOLOGICAL | 0.5 mL single annual dose |
Inclusion Criteria: * Aged ≥ 65 years on the day of vaccination. * Informed consent form signed. * Medically stable. (Subjects may have underlying chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, as long as their symptoms/signs are controlled. If they ar...
Inactivated, Split-Virion Influenza Virus is an injectable influenza vaccine candidate developed by Sanofi. It is designed to stimulate immune response against influenza and related Orthomyxoviridae infections. The vaccine is in Phase 2 clinical development and has been studied in adults, elderly subjects, and renal transplant recipients.
Sanofi, which trades under the ticker SNY, develops Inactivated, Split-Virion Influenza Virus. Sanofi has sponsored four completed Phase 2 trials of the vaccine, including studies conducted in France, Belgium, Czechia, Lithuania, and the United States.
Inactivated, Split-Virion Influenza Virus is in Phase 2 clinical development. All four of its recorded trials are Phase 2 studies and all four are completed, with no active trials currently listed. The vaccine is investigational and has not been approved by the FDA.
Four completed Phase 2 trials have evaluated Inactivated, Split-Virion Influenza Virus: NCT00776438 in adults and elderly subjects, NCT00703651 comparing intradermal administration with Vaxigrip in adults, NCT00606359 in renal transplant subjects, and NCT00524940 describing safety and immunogenicity of Fluzone. Together these trials enrolled 8,638 participants.
Inactivated, Split-Virion Influenza Virus is also known as inactivated, split-virion influenza vaccine and high-dose inactivated, split-virion influenza vaccine. Its clinical program includes a trial of Fluzone and a trial comparing intradermal administration against Vaxigrip, both of which are influenza vaccine products.
The Phase 2 trials of Inactivated, Split-Virion Influenza Virus were randomized, double-blind, and active-controlled, with no biomarker-based patient selection. They enrolled adults aged 18 years and older of all sexes, including healthy volunteers, and evaluated immune response, safety, and immunogenicity across a combined 8,638 participants.