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Also known as Fluzone® High-Dose (HD) influenza vaccine
Fluzone High-Dose influenza vaccine · 1 trial · 1 indication
Geometric mean of HAI titers at 2-weeks and 4-weeks post-trial intervention against the influenza virus strains contained in the vaccine among participants receiving concomitant Fluzone® HD influenza vaccine and MK-1406 compared to participants who receive Fluzone® HD and placebo will be determined. HAI testing will be performed using validated methods in accordance with applicable Good Clinical Laboratory Practice (GCLP) and laboratory Standard Operating Procedures (SOPs). Geometric Mean Titers (GMTs) will be summarized by treatment group and influenza strain.
Seroconversion is defined as a 4-fold increase in influenza titer as measured by HAI assay at each visit compared to baseline. Seroconversion rates at 2-weeks and 4-weeks post-trial intervention against the influenza virus strains contained in the vaccine among participants receiving concomitant Fluzone® HD influenza vaccine and MK-1406 compared to participants who receive Fluzone® HD and placebo will be determined. Seroconversion rates will be summarized by treatment group and influenza strain.
| Arm | Type | Description |
|---|---|---|
| Fluzone® High-Dose (HD) plus MK-1406 | EXPERIMENTAL | Participants will receive open-label Fluzone® HD influenza vaccine by intramuscular (IM) injection plus MK-1406 by subcutaneous (SC) injection on Day 1. |
| Fluzone® HD plus Placebo | PLACEBO_COMPARATOR | Participants will receive open-label Fluzone® HD influenza vaccine by IM injection plus placebo by SC injection on Day 1. |
| Name | Type | Description |
|---|---|---|
| Fluzone® High-Dose (HD) influenza vaccine | BIOLOGICAL | Fluzone® HD injectable suspension administered by intramuscular (IM) injection |
| MK-1406 Injection | COMBINATION_PRODUCT | MK-1406 liquid for injection administered subcutaneously |
| Placebo | COMBINATION_PRODUCT | MK-1406 matched liquid for SC injection |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Be ≥18 to ≤49 years of age * Be deemed healthy by the Investigator * Have not received any seasonal influenza vaccine and have not had a diagnosed or suspected influenza infection within 12 months prior...
Fluzone High-Dose influenza vaccine is an investigational vaccine being studied in healthy participants. It is being evaluated in a Phase 1 clinical trial to assess its immunogenicity when given with CD388/MK1406. The vaccine is intended for use in healthy adults aged 18 years and older.
Fluzone High-Dose influenza vaccine is being developed by Cidara Therapeutics, Inc., which trades under the ticker CDTX. The company is conducting a Phase 1 clinical trial to evaluate the vaccine's effect on immunogenicity when combined with CD388/MK1406 in healthy participants.
Fluzone High-Dose influenza vaccine is in Phase 1 clinical development. It is currently being studied in an active, not recruiting trial with 710 participants. The vaccine is investigational and has not been approved by regulatory authorities.
Fluzone High-Dose influenza vaccine is being studied in one Phase 1 clinical trial with the identifier NCT07300085. The trial is titled 'A Trial to Evaluate the Effect of CD388/MK1406 on the Immunogenicity of Fluzone® HD Vaccine' and is being conducted in the United States with 710 healthy participants.
Yes, Fluzone High-Dose influenza vaccine is also known as Fluzone® High-Dose (HD) influenza vaccine. Both names refer to the same investigational vaccine being developed by Cidara Therapeutics, Inc. for use in healthy participants.