Drugs / Flublok Quadrivalent

Trials 4

2015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT03658629 Sep 2018 → Apr 2019 influenza Novavax Terminated No outcome recorded
Phase 32 trials
Phase 3 NCT03460743 Mar 2018 → Oct 2019 influenza Laboratorios Liomont Completed No outcome recorded
Phase 3 NCT02290509 Oct 2014 → May 2015 influenza Protein Sciences Corporation Completed No outcome recorded
Phase 41 trial
Phase 4 NCT05518500 Aug 2022 → Dec 2026 expected premature aging syndrome The Jackson Laboratory Active not recruiting No outcome recorded
Comparator or background therapy1 trial
Phase 4 NCT05514002 Comparator Sep 2022 → Dec 2023 influenza Fatimah Dawood Terminated No outcome recorded Stop: Business

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
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.

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as Flublok Quadrivalent “Flublok Quadrivalent® (Quadrivalent Recombinant Influenza Vaccine, Seasonal Formulation)” NCT03460743 ↗
6

“Sponsor Product Identifiers Flublok® Quadrivalent of Laboratories Liomont, S.A. de C.V.” NCT03460743 ↗

“a single dose of RIV (Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain)” NCT05514002 ↗

“Participants will receive Flublok Quadrivalent in the 2024-2025 flu season.” NCT05518500 ↗

NCT02290509 ↗

NCT03658629 ↗

NCT05514002 ↗

Modality Vaccine “A new quadrivalent recombinant influenza vaccine (RIV4)” PMID 28968871 ↗ Dec 2017
Route Intramuscular “Intramuscular injection of vaccine containing 4 x 45µg (180µg total)” NCT02290509 ↗