Drugs / SPUNOLEUCEL
SPUNOLEUCEL
Trials 7 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05401448 | Jun → Dec 2021 | COVID-19 | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06683352 | Nov 2024 → Jul 2025 | COVID-19, influenza | BioNTech SE | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00329966 | Jun 2006 → ? | influenza | Novartis | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06178991 | Dec 2023 → Nov 2024 | COVID-19, influenza | BioNTech SE | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT00311428 | Oct 2005 → ? | influenza | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00329251 | Apr 2003 → Mar 2006 | HIV infectious disease | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02200276 | Mar 2014 → Nov 2026 expected | influenza | Johns Hopkins University | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT04933968 Comparator | Mar 2022 → Jan 2024 | influenza, parainfluenza infectious disease, respiratory syncytial virus infectious disease | AlloVir | Terminated | No outcome recorded |
Press releases naming this drug 16 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-10-20 | Sanofi | Press Release: Sanofi’s high-dose influenza vaccine demonstrates superior protection for older adults against hospitalization vs standard-dose sanofi.com ↗ |
| 2025-08-08 | BioNTech SE | BioNTech Reaches Agreement to Receive a Non-exclusive License for mRNA-based COVID-19 and/or Influenza Products and Resolve Patent Litigation with CureVac and GSK biontech.com ↗ |
| 2024-12-11 | Sanofi | Press Release: Two combination vaccine candidates for prevention of influenza and COVID-19 granted Fast Track designation in the US sanofi.com ↗ |
| 2024-08-16 | Pfizer | Pfizer and BioNTech Provide Update on mRNA-based Combination Vaccine Program Against Influenza and COVID-19 in Individuals 18-64 Years of Age pfizer.com ↗ |
| 2024-08-16 | BioNTech SE | Pfizer and BioNTech Provide Update on mRNA-based Combination Vaccine Program Against Influenza and COVID-19 in Individuals 18-64 Years of Age biontech.com ↗ |
| 2023-10-26 | Pfizer | Pfizer and BioNTech Announce Positive Topline Data for mRNA-based Combination Vaccine Program Against Influenza and COVID-19 pfizer.com ↗ |
| 2023-10-26 | BioNTech SE | Pfizer and BioNTech Announce Positive Topline Data for mRNA-based Combination Vaccine Program Against Influenza and COVID-19 biontech.com ↗ |
| 2022-12-09 | BioNTech SE | Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza biontech.com ↗ |
| 2022-11-03 | BioNTech SE | Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19 biontech.com ↗ |
| 2022-09-14 | Pfizer | Pfizer Initiates Phase 3 Study of mRNA-Based Influenza Vaccine pfizer.com ↗ |
| 2022-06-22 | Sanofi | Media Update: Survey: Physicians and pharmacists would tell CDC to recommend vaccine like Fluzone High-Dose Quadrivalent (Influenza Vaccine) for people 65 years and older sanofi.com ↗ |
| 2021-10-07 | Sanofi | Sanofi: Positive results from the first study of high-dose influenza vaccine with a COVID-19 mRNA booster support co-administration recommendations sanofi.com ↗ |
| 2021-03-31 | Sanofi | Sanofi to build new facility in Canada to increase global availability of high-dose influenza vaccine sanofi.com ↗ |
| 2018-08-16 | Pfizer | BioNTech Signs Collaboration Agreement with Pfizer to Develop mRNA-based Vaccines for Prevention of Influenza pfizer.com ↗ |
| 2018-08-16 | BioNTech SE | BioNTech Signs Collaboration Agreement with Pfizer to Develop mRNA-based Vaccines for Prevention of Influenza biontech.com ↗ |
| 2015-08-03 | Novartis Pharmaceuticals | Novartis completes divestiture of influenza vaccines business to CSL Limited for USD 275 million novartis.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SPUNOLEUCEL | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068442 ↗ |
| Known as | ALV-106 | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068442 ↗ |
| Known as | ALVR106 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04933968 ↗ |
| Known as | Fluzone High-Dose | “administer the Fluzone High-Dose TIV vaccine” NCT02200276 ↗ |
| Known as | Influenza | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05401448 ↗ |
| Known as | Influenza and COVID Combination Vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06683352 ↗ |
| Known as | Influenza and COVID-19 Combination A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06178991 ↗ |
| Known as | Influenza and COVID-19 Combination B | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06178991 ↗ |
| Known as | Surface Antigen, Inactivated, Influenza | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00329966 ↗ |
| Modality | Vaccine | “three widely used conventional influenza vaccines” NCT00311428 ↗ |
| Route | Other | “Infusion, visually identical to placebo” NCT04933968 ↗ |