Drugs / RIV4
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05513053 | Oct 2022 → Oct 2023 | — | Sanofi Pasteur, a Sanofi Company | Completed | Met primary |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT06850051 Comparator | Mar → Dec 2025 | parainfluenza infectious disease, respiratory syncytial virus infectious disease | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT05829356 Comparator | Apr 2023 → Mar 2024 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 1/2 | NCT05624606 Comparator | Nov 2022 → Mar 2024 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 2 | NCT04576702 Comparator | Oct 2020 → Mar 2021 | influenza | Seqirus | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-11-18 | Sanofi | Regulatory European Commission approves Supemtek® (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older sanofi.com ↗
The European Commission has granted a marketing authorization for Supemtek ® , a quadrivalent (four-strain) recombinant influenza vaccine, for the prevention of influenza in adults aged 18 years and older. |
| 2020-09-22 | Sanofi | Regulatory CHMP recommends approval of Supemtek® (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older sanofi.com ↗
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Supemtek® (recombinant influenza vaccine) for active immunization for the prevention of influenza in adults. |
All press releases naming this drug 2 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RIV4 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04576702 ↗ |
| Known as | QIVr | “Eligible participants aged ≥50 years were randomised 1: 1:1:1 to receive aQIVc (n = 116), a non-adjuvanted quadrivalent cell-based influenza vaccine (QIVc; n = 119), an...” PMID 39946829 ↗ Feb 2025 |
| Known as | Supemtek | “RIV4 (Supemtek®)” NCT06850051 ↗ |
| Modality | Vaccine | “Licensed, Recombinant Quadrivalent Influenza Vaccine” NCT04576702 ↗ |
| Route | Intramuscular | “RIV4 will be administered as a single dose intramuscularly on Day 1” NCT04576702 ↗ |