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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...