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Also known as mRNA-1018 for H5 Only
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...
Top 6 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 1 | PHASE3 | mRNA-1018-H5 |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | Flu/COVID-19 mRNA combination vaccine |
mRNA-1018-H5 is an investigational pandemic influenza vaccine developed by Moderna, Inc. It is designed for use in healthy adults and is being studied in a Phase 3 clinical trial. It is an mRNA-based vaccine candidate rather than an approved product.
mRNA-1018-H5 is being developed for the prevention of influenza, specifically pandemic H5 influenza. Its only registered study enrolls healthy adults aged 18 years and older in the United States and the United Kingdom. The vaccine remains investigational and has not been approved for use.
mRNA-1018-H5 is developed by Moderna, Inc., which trades on the Nasdaq under the ticker MRNA. Moderna is the sponsor of the vaccine's clinical program, including its Phase 3 trial in pandemic influenza.
mRNA-1018-H5 is in Phase 3 clinical development. Its single registered trial, NCT07496450, is a Phase 3 study that is currently active but no longer recruiting participants. The vaccine is investigational and has not been approved by the FDA.
mRNA-1018-H5 is being studied in one clinical trial, NCT07496450, titled A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults. The Phase 3 trial has an enrollment of 4,050 participants, is randomized, double-blind, and placebo-controlled, and is being conducted in the United States and the United Kingdom.
Yes, mRNA-1018-H5 is also known as mRNA-1018 for H5 Only. Both names refer to the same Moderna pandemic influenza vaccine candidate, which targets H5 influenza and is currently in Phase 3 testing.