Drugs / mRNA-1273.815
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT04927065 | May 2021 → Nov 2023 | COVID-19 | ModernaTX, Inc. | Completed | Met primary |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT06354998 | Apr → May 2024 | Orthocoronavirinae infectious disease | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05815498 | Mar 2023 → Apr 2025 | COVID-19 | ModernaTX, Inc. | Completed | Met primary |
| Phase 3 | NCT05436834 | Jun 2022 → Oct 2025 | COVID-19 | ModernaTX, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-09-06 | ModernaTX, Inc. | Results Moderna Clinical Trial Data Confirm Its Updated Covid-19 Vaccine Generates Strong Immune Response in Humans Against BA.2.86 q4web.com ↗
These results demonstrate that our updated COVID-19 vaccine generates a strong human immune response against the highly mutated BA.2.86 variant. |
| 2023-08-17 | ModernaTX, Inc. | Results Moderna Clinical Trial Data Confirm Its Updated COVID-19 Vaccine Generates Robust Immune Response in Humans Against Widely Circulating Variants q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced that preliminary clinical trial data confirm its updated COVID-19 vaccine for the fall 2023 vaccination season showed a significant boost in neutralizing antibodies against EG.5 and FL.1.5.1 variants. |
| 2023-07-03 | ModernaTX, Inc. | Regulatory Moderna Submits Regulatory Application to the European Medicines Agency for Its Updated COVID-19 Vaccine q4web.com ↗
today announced that it has submitted a regulatory application to the European Medicines Agency (EMA) for its updated COVID-19 vaccine encoding the spike protein for the XBB.1.5 sublineage of SARS-CoV-2. |
| 2023-06-22 | ModernaTX, Inc. | Regulatory Moderna Files for FDA Authorization of Its Updated COVID-19 Vaccine q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has completed submission of a regulatory application to the U.S. Food and Drug Administration for its updated COVID-19 vaccine containing spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 (mRNA-1273.815). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-09-06 | ModernaTX, Inc. | Moderna Clinical Trial Data Confirm Its Updated Covid-19 Vaccine Generates Strong Immune Response in Humans Against BA.2.86 q4web.com ↗ |
| 2023-08-17 | ModernaTX, Inc. | Moderna Clinical Trial Data Confirm Its Updated COVID-19 Vaccine Generates Robust Immune Response in Humans Against Widely Circulating Variants q4web.com ↗ |
| 2023-07-03 | ModernaTX, Inc. | Moderna Submits Regulatory Application to the European Medicines Agency for Its Updated COVID-19 Vaccine q4web.com ↗ |
| 2023-06-22 | ModernaTX, Inc. | Moderna Files for FDA Authorization of Its Updated COVID-19 Vaccine q4web.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mRNA-1273.815 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05436834 ↗ |
| Modality | Messenger RNA (mRNA) | “mRNA-1273.815 vaccine” NCT05436834 ↗ |
| Route | Intramuscular | “Participants will receive 1 intramuscular booster dose of 50 μg of mRNA-1273.815 or 50 ug of mRNA-1273.231 on Day 1.” NCT04927065 ↗ |