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Also known as Fluzone®
Influenza Virus Vaccine USP Trivalent Types A and B · 3 trials · 4 indications
The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay
The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination.
Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature).
Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.
| Arm | Type | Description |
|---|---|---|
| Fluzone Intradermal Vaccine Lot 1 | EXPERIMENTAL | Participants will receive a dose of Influenza intradermal vaccine Lot 1 |
| Fluzone Intradermal Vaccine Lot 2 | EXPERIMENTAL | Participants will receive a dose of Influenza intradermal vaccine Lot 2 |
| Fluzone Intradermal Vaccine Lot 3 | EXPERIMENTAL | Participants will receive a dose of Influenza intradermal vaccine Lot 3 |
| Fluzone Intramuscular Vaccine | ACTIVE_COMPARATOR | Participants will receive a dose of influenza intramuscular vaccine |
| Group 1: Fluzone ID After Fluzone ID | EXPERIMENTAL | Participants will receive Fluzone intradermal (ID) following Fluzone ID in Study FID31 |
| Group 2: Fluzone IM After Fluzone ID | EXPERIMENTAL | Participants will receive Fluzone intramuscular (IM) following Fluzone ID in Study FID31 |
| Group 3: Fluzone IM After Fluzone IM | EXPERIMENTAL | Participants will receive Fluzone intramuscular (IM) following Fluzone IM in Study FID31 |
| Group 4: Fluzone ID After Fluzone IM | EXPERIMENTAL | Participants will receive Fluzone intradermal (ID) following Fluzone intramuscular (IM) in Study FID31 |
| Group 1a: Fluzone ID After Fluzone ID | EXPERIMENTAL | - |
| Group 1b: Fluzone IM After Fluzone ID | EXPERIMENTAL | - |
| Group 2a: Fluzone IM After Fluzone IM | ACTIVE_COMPARATOR | - |
| Group 2b: Fluzone ID After Fluzone IM | EXPERIMENTAL | - |
| Group 3: Fluzone HD After Fluzone HD | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Influenza Virus Vaccine USP Trivalent Types A and B | BIOLOGICAL | 0.1 mL, Intradermal |
Inclusion Criteria : * Aged 18 to 64 years on the day of vaccination. * Informed consent form signed and dated. * Able to attend all scheduled visits and to comply with all trial procedures. * For women of child bearing potential, avoid becoming pregnant (use of an effective method of contraception...
Influenza Virus Vaccine USP Trivalent Types A and B is used to prevent influenza and infections caused by Orthomyxoviridae viruses. It is a trivalent vaccine covering two influenza A strains and one influenza B strain, developed by Sanofi for active immunization in adults, including the elderly.
Sanofi develops and manufactures Influenza Virus Vaccine USP Trivalent Types A and B. Sanofi trades on the New York Stock Exchange under the ticker SNY. The vaccine is part of Sanofi's influenza vaccine portfolio, which includes the Fluzone product family.
Influenza Virus Vaccine USP Trivalent Types A and B has been studied in Phase 2 and Phase 3 clinical trials. The Phase 2 studies are completed, and a Phase 3 study has also been completed. The vaccine remains in clinical development as an investigational product.
Influenza Virus Vaccine USP Trivalent Types A and B has been evaluated in completed trials including NCT01011049, a Phase 2 revaccination study in healthy adults; NCT00775450, a Phase 2 revaccination study in ambulatory elderly subjects; and NCT00772109, a Phase 3 intradermal comparison study in adults.
Yes. Influenza Virus Vaccine USP Trivalent Types A and B is also known as Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal, or simply Fluzone Intradermal. These names refer to the same Sanofi trivalent influenza vaccine product.
Across its clinical trials, Influenza Virus Vaccine USP Trivalent Types A and B enrolled a total of 4,292 participants. The trials included 1,250 healthy adults in NCT01011049, 807 ambulatory elderly subjects in NCT00775450, and 4,292 adults in the Phase 3 study NCT00772109.