Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mRNA-1018-H5 · 1 trial · 1 indication
HAI Titer \>=1:40.
Seroconversion is defined as a Day 43 titer ≥1:40 if baseline is \<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in HAI titer measured by HAI assay.
| Arm | Type | Description |
|---|---|---|
| mRNA-1018-H5 Vaccine | EXPERIMENTAL | Participants will receive mRNA-1018-H5 vaccine by intramuscular (IM) injection on Day 1 and Day 22. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to mRNA-1018-H5 vaccine by IM injection on Day 1 and Day 22. |
| Name | Type | Description |
|---|---|---|
| mRNA-1018-H5 | BIOLOGICAL | Sterile liquid for injection. |
| Placebo | BIOLOGICAL | Sterile liquid for injection. |
Key Inclusion Criteria: * Healthy as determined by medical evaluation including medical history; and physical examination. Participants with clinically stable chronic medical conditions are permitted. * Participants who are assigned female at birth or could become pregnant are eligible to participa...
mRNA-1018-H5 is an investigational vaccine being developed for influenza, specifically as a pandemic influenza vaccine. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
mRNA-1018-H5 is being developed by Moderna, Inc., a biotechnology company publicly traded under the ticker symbol MRNA on the NASDAQ stock exchange.
mRNA-1018-H5 is currently in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA or other regulatory agencies. The ongoing Phase 3 trial is active but not recruiting participants.
mRNA-1018-H5 is being studied in a Phase 3 clinical trial with the identifier NCT07496450. This randomized, double-blind, placebo-controlled study is evaluating the vaccine in healthy adults aged 18 years and older, with an enrollment of 4,050 participants across the United States and United Kingdom.
Yes, mRNA-1018-H5 is being developed as a pandemic influenza vaccine. The ongoing Phase 3 trial is specifically titled 'A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults,' indicating its intended use for pandemic influenza preparedness.