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Also known as Vaxigrip®, Fluzone®
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 investigational vaccine developed by Sanofi (ticker SNY) for influenza and Orthomyxoviridae infection. It is a split-virion formulation, meaning the virus is inactivated and broken apart. It has been studied in Phase 2 clinical trials, including a high-dose version, and is not described as approved.
It is being studied for the prevention of influenza and Orthomyxoviridae infection. Clinical trials have enrolled adults and elderly subjects, renal transplant recipients, and healthy volunteers. The program includes a high-dose inactivated, split-virion influenza vaccine formulation evaluated for immune response against influenza.
Sanofi, which trades under the ticker SNY, is the developer of Inactivated, Split-Virion Influenza Virus. The company has sponsored the clinical trial program for this inactivated, split-virion influenza vaccine, including studies comparing intradermal administration with Vaxigrip and a trial describing Fluzone safety and immunogenicity.
Inactivated, Split-Virion Influenza Virus is in Phase 2 development. All four listed trials are Phase 2 studies, and all four are completed, with no active trials currently listed. The program has enrolled a total of 9,616 participants across randomized, double-blind, active-controlled studies.
Four completed Phase 2 trials are listed: NCT00776438 in adults and elderly subjects in France, NCT00703651 comparing intradermal administration with Vaxigrip in Belgium, Czechia, and Lithuania, NCT00606359 in renal transplant subjects in France, and NCT00524940 describing Fluzone safety and immunogenicity in the United States.
Inactivated, Split-Virion Influenza Virus is also known as inactivated, split-virion influenza vaccine and high-dose inactivated, split-virion influenza vaccine. Fluzone and Vaxigrip appear as comparator or study vaccines in the clinical trials, including NCT00524940 for Fluzone and NCT00703651 comparing intradermal administration with Vaxigrip.