Drugs / SPUNOLEUCEL
SPUNOLEUCEL
Trials 7
| 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 |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT04933968 Comparator | Mar 2022 → Jan 2024 | influenza, parainfluenza infectious disease, respiratory syncytial virus infectious disease | AlloVir | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2024-08-16 | Pfizer | Results 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 ↗
The trial did not meet one of its primary immunogenicity objectives of non-inferiority against the influenza B strain despite obtaining higher influenza A responses and comparable COVID-19 responses versus the comparator vaccines |
| 2024-08-16 | BioNTech SE | Results 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 ↗
The trial did not meet one of its primary immunogenicity objectives of non-inferiority against the influenza B strain despite obtaining higher influenza A responses and comparable COVID-19 responses versus the comparator vaccines |
| 2023-10-26 | Pfizer | Results Pfizer and BioNTech Announce Positive Topline Data for mRNA-based Combination Vaccine Program Against Influenza and COVID-19 pfizer.com ↗
The data from the trial showed that the companies' lead formulations demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains. |
| 2023-10-26 | BioNTech SE | Results Pfizer and BioNTech Announce Positive Topline Data for mRNA-based Combination Vaccine Program Against Influenza and COVID-19 biontech.com ↗
The data from the trial showed that the companies' lead formulations demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains. |
| 2023-10-05 | Pfizer | Results Pfizer Presents New Data at IDWeek 2023 Highlighting Advances in Prevention and Treatment of Certain Respiratory Illnesses and Other Infectious Diseases pfizer.com ↗
Eight abstracts have been selected for oral presentation, including data on the successful coadministration of ABRYSVO with an influenza vaccine in older adults and results from the Phase 3 REVISIT study of Pfizer’s investigational antibiotic combination aztreonam-avibactam (ATM-AVI) candidate. |
| 2023-05-09 | Novavax | Results Positive Phase 2 Topline Results Show Novavax's COVID-Influenza Combination, Stand-alone Influenza and High-dose COVID Vaccine Candidates Demonstrate Robust Immune Responses novavax.com ↗
The stand-alone influenza vaccine candidate achieved statistically significant hemagglutination inhibition (HAI) antibody responses 31 to 56% higher for all four strains compared to Fluad. |
| 2022-12-09 | BioNTech SE | Regulatory Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza biontech.com ↗
NEW YORK and MAINZ, GERMANY, DECEMBER 9, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the companies have received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and COVID-19, which aims to help prevent two respiratory diseases with a single injection. |
| 2021-09-29 | Pfizer | Results Positive Top-line Results of Pfizer’s Phase 3 Study Exploring Coadministration of Prevnar 20™ With Seasonal Flu Vaccine in Older Adults Released pfizer.com ↗
Responses elicited by PREVNAR 20 for all 20 serotypes and by seasonal influenza vaccine when given together were noninferior (the study’s primary immunogenicity objectives) to those elicited by the vaccines when administered one month apart. |
All press releases naming this drug 20 releases
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 NCT00311428 ↗ |
| 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 ↗ |