Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
V512 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | V512 |
| 2 | PLACEBO_COMPARATOR | Placebo to V512 |
| Name | Type | Description |
|---|---|---|
| V512 | BIOLOGICAL | Subjects received 1 of 8 formulations of the BIPCV/IMX vaccine (V512) in a 3-dose regimen of 0.5 mL injections at Day 1, Month 2, and Month 6: 1\) 0.5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 2) 0.5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 3) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 4) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 5) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 100 mcg IMX; 6) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 7) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 8) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 100 mcg IMX; |
| Comparator: Placebo to V512 | BIOLOGICAL | Subjects received placebo to the BIPCV/IMX vaccine (V512) in a 3-dose regimen of 0.5 mL injections at Day 1, Month 2, and Month 6. |
Inclusion Criteria: * Subject is in good physical health * Subject is not in the category of individuals recommended by the CDC to receive influenza vaccine for the upcoming 2 influenza seasons * Subject agrees not to seek vaccination with licensed influenza vaccines during the study * Female subje...
V512 is an investigational monoclonal antibody being developed for influenza, a viral infection of the respiratory tract. It is currently in Phase 1 clinical development, meaning it is being studied in early-stage trials to evaluate its safety and tolerability in healthy adults. V512 is not yet approved by regulatory authorities.
V512 is being developed by Merck & Company, Inc., a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical research on V512 as part of its infectious disease portfolio.
V512 is in Phase 1 clinical development for influenza. It has completed one Phase 1 trial, which was a randomized, double-blind, placebo-controlled study in healthy adults. The drug remains investigational and has not been approved for any use.
V512 has been studied in one clinical trial, identified as NCT00851266, titled 'A Study of a Bivalent Influenza Peptide Conjugate Vaccine in Healthy Adults.' This Phase 1 trial enrolled 187 participants and has been completed. The trial was randomized, double-blind, and placebo-controlled.
No, V512 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for influenza. The completed Phase 1 trial evaluated the drug in healthy adults, but further studies are needed to establish safety and efficacy before any regulatory approval could be considered.