Fluarix

also known as Influsplit SSW · Adjuvanted Fluarix · Alpha-Rix · Fluarix Quadrivalent · GlaxoSmithKline Biologicals' licensed influenza vaccine · TIV

Vaccine

Developed for: influenza
Investigated by: GlaxoSmithKline · National Institute of Allergy and Infectious Diseases (NIAID) · A*Star · Janssen Vaccines & Prevention B.V. · National Heart, Lung, and Blood Institute (NHLBI) · Public Health England
+6 more
· Roswell Park Cancer Institute · Royal Free and University College Medical School · Sanofi · Tan Tock Seng Hospital · University of California, San Diego · University of Melbourne

Trials 30

today NCT05479370 · Ph 3 NCT05170399 · Ph 4 NCT03339713 · Ph 2 NCT04484532 · Ph 0 NCT02707692 · not/applicable NCT01196026 · Ph 4 NCT01173211 · Ph 2 NCT01144299 · Ph 3 NCT00968890 · Ph 2 NCT00971425 · Ph 3 NCT00920374 · Ph 3 NCT00905125 · Ph 2 NCT00764790 · Ph 3 NCT00706563 · Ph 3 NCT00476307 · Ph 3 NCT00453986 · Ph 3 NCT00442975 · Ph 4 NCT00383123 · Ph 3 NCT00386113 · Ph 2 NCT00386698 · Ph 2 NCT00377611 · Ph 4 NCT00377585 · Ph 2 NCT00363870 · Ph 4 NCT00380211 · Ph 3 NCT00345904 · Ph 3 NCT00197288 · Ph 3 NCT00318149 · Ph 2 NCT00318058 · Ph 1 NCT00197223 · Ph 3 NCT00100399 · Ph 3

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT04484532	Oct 2017 → Jun 2022	acute myeloid leukemia, myelodysplastic syndrome	Roswell Park Cancer Institute	Completed	No outcome recorded
Phase 11 trial
Phase 1	NCT00318058	Oct → Nov 2005	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 28 trials · 2 met primary
Phase 2	NCT03339713	Dec 2017 → Jul 2018	—	Janssen Vaccines & Prevention B.V.	Completed	Met primary
Phase 2	NCT01173211	Sep 2010 → Nov 2011	influenza	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00968890	Sep 2009 → Sep 2010	influenza	GlaxoSmithKline	Completed	Met primary
Phase 2	NCT00905125	Jun 2009 → Mar 2010	influenza	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00386113	Oct → Nov 2006	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00386698	Oct → Dec 2006	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00377585	Sep 2006 → Jan 2007	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00318149	Oct 2005 → May 2006	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 314 trials · 2 met primary
Phase 3	NCT05479370	Sep 2022 → Apr 2023	—	Tan Tock Seng Hospital	Completed	Met primary
Phase 3	NCT01144299	Jun → Jul 2010	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00971425	Sep → Nov 2009	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00920374	Jun → Jul 2009	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00764790	Oct 2008 → Mar 2009	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00706563	Jul 2008	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00476307	Jun → Jul 2007	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00453986	Apr → Nov 2007	meningococcal infection	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00383123	Nov 2006 → Oct 2007	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00380211	Sep → Nov 2006	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00345904	Jul → Aug 2006	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00197288	Oct 2005 → May 2006	influenza	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT00197223	Sep → Oct 2005	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00100399	Dec 2004	influenza	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded

Phase 45 trials · 1 met primary
Phase 4	NCT05170399	Sep 2022 → Aug 2026 overdue	lymphoma	National Heart, Lung, and Blood Institute (NHLBI)	Recruiting	No outcome recorded
Phase 4	NCT01196026	Sep 2010 → May 2011	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00442975	Mar → Sep 2007	influenza	Public Health England	Completed	No outcome recorded
Phase 4	NCT00377611	Oct 2006 → Jun 2007	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00363870	Sep 2006 → Jun 2007	influenza	GlaxoSmithKline	Completed	Met primary
Phase not applicable1 trial · 1 missed
—	NCT02707692	Aug 2016 → Apr 2020	AIDS	University of California, San Diego	Completed	Missed primary
Comparator or background therapy33 trials
Phase 1	NCT02330003 Comparator	May → Aug 2013	—	Il-Yang Pharm. Co., Ltd.	Completed	No outcome recorded
Phase 1	NCT01096056 Background	Apr → Dec 2010	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00693706 Comparator	Jun 2008 → Mar 2009	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 1/2	NCT01248208 Comparator	Sep 2010 → Sep 2011	food allergy	Walter Reed Army Medical Center	Completed	No outcome recorded
Phase 2	NCT01195779 Comparator	Sep 2010 → Mar 2011	influenza	GlaxoSmithKline	Terminated	No outcome recorded
Phase 2	NCT00985790 Comparator	Oct 2009 → May 2010	influenza	GlaxoSmithKline	Completed	Met primary
Phase 2	NCT00538473 Comparator	Oct → Dec 2007	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00545025 Comparator	Oct → Dec 2007	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00538213 Comparator	Oct → Nov 2007	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00540592 Comparator	Oct 2007 → Jun 2008	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00540228 Comparator	Oct 2007 → May 2008	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00532298 Comparator	Sep → Nov 2007	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00502593 Comparator	Jul 2007 → Dec 2009	influenza	GlaxoSmithKline	Completed	Met primary
Phase 2	NCT00397215 Background	Nov 2006 → Sep 2009	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00374842 Comparator	Oct → Nov 2006	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00363077 Comparator	Oct → Nov 2006	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00321373 Comparator	May → Jul 2006	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00321763 Comparator	Apr → Jul 2006	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT06602024 Comparator	Sep 2024 → Aug 2025	influenza	ModernaTX, Inc.	Completed	Met primary
Phase 3	NCT01959945 Comparator	Nov 2013 → Jun 2014	influenza	Protein Sciences Corporation	Completed	No outcome recorded
Phase 3	NCT01711736 Comparator	Nov 2012 → Feb 2013	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00765076 Comparator	Oct 2008 → Dec 2009	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00772889 Comparator	Oct 2008 → Dec 2009	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00760617 Comparator	Oct 2008 → May 2009	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00753272 Comparator	Sep 2008 → Jun 2010	influenza	GlaxoSmithKline	Completed	Mixed
Phase 3	NCT00529516 Comparator	Oct → Dec 2007	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00385255 Background	Oct 2006 → Feb 2007	diphtheria, tetanus	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00319098 Comparator	May 2006 → Jan 2007	influenza	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT03722589 Comparator	Sep 2018 → Jul 2020	influenza	Centers for Disease Control and Prevention	Completed	No outcome recorded
Phase 4	NCT02640989 Comparator	Oct 2014	influenza	Center for Disease Prevention and Control of Beijing Military Region	Completed	No outcome recorded
Phase 4	NCT01730378 Comparator	Dec 2012 → Dec 2013	influenza	GlaxoSmithKline	Completed	Met primary
—	NCT00902278 Comparator	Oct 2008 → Apr 2016	—	University of Massachusetts, Worcester	Completed	No outcome recorded
—	NCT00679237 Comparator	Sep 2007 → Dec 2019	coronary artery disorder	Sorlandet Hospital HF	Completed	No outcome recorded

Press releases naming this drug 3 releases

Date	Issuer	Release
2018-03-06	GlaxoSmithKline	New clinical data demonstrate high vaccine efficacy of Fluarix Tetra (Influenza Vaccine) in children 6-35 months of age gsk.com ↗
2018-02-15	GlaxoSmithKline	GSK receives European approval for expanded indication for Fluarix Tetra (Influenza Vaccine) for ages six months and older gsk.com ↗
2009-11-09	GlaxoSmithKline	Pandemic 2009 Influenza Update: Pandemrix™ data on co-administration with annual seasonal influenza vaccine (Fluarix®) gsk.com ↗

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 64 sources stand behind the page.

Field	Value	Cited text
Known as	Fluarix	“Study subjects will be randomized 1:1:1 to receive one of the following three 2010-2011 seasonal inactivated trivalent influenza vaccines: Fluarix®, Agriflu®, or Fluzone® (60...” NCT01173211 ↗ 65 “A trivalent inactivated influenza vaccine (Fluarix (™) , GlaxoSmithKline Biologicals) was licensed under US accelerated approval regulations.” PMID 21285532 ↗ Jan 2011 “Study Regimen/Intervention: This is a double blind RCT of two vaccines (Pneumovax®23 and Fluarix®) plus placebo (sterile saline injection).” NCT02707692 ↗ “Compared With Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years Old and Above” NCT00321373 ↗ “GSK Biologicals' Influenza Vaccine (Fluarix™) Administered Intramuscularly in Adults.” NCT00197223 ↗ “received 1 dose of Fluarix® vaccine at Day 0” NCT00693706 ↗ “vaccine (FLuarix, Influvac etc)” NCT00679237 ↗ “Fluarix (age 3y and older)” NCT01248208 ↗ “Fluarix” NCT04484532 ↗ NCT00905125 ↗ NCT00706563 ↗ Show 55 more sources
Known as	Adjuvanted Fluarix	“influenza vaccine Fluarix, Adjuvanted Fluarix” NCT00318058 ↗
Known as	Alpha-Rix	“Fluarix™ (Known as Alpha-Rix™ in Belgium)” NCT00318149 ↗
Known as	Fluarix Quadrivalent	“one of two standard dose egg-based vaccines (Fluzone® Quadrivalent by Sanofi Pasteur, 15µg of HA per strain and Fluarix® Quadrivalent by GlaxoSmithKlein, 15µg of HA per strain)” NCT03722589 ↗
Known as	GlaxoSmithKline Biologicals' licensed influenza vaccine	“GlaxoSmithKline Biologicals' licensed influenza vaccine” NCT00318149 ↗
Known as	Influsplit SSW	“the Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2010-2011 season” NCT01144299 ↗ 3 “Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People 18 Years Old or Above” NCT00476307 ↗ “Fluarix™ (Influsplit SSW®) 2006/2007” NCT00345904 ↗ “Fluarix™/Influsplit SSW®” NCT00920374 ↗
Known as	TIV	“In this study we describe the immunogenicity results from a subset of older people (N = 5187) who participated in a Phase 3 randomized, observer-blinded trial of AS03-TIV...” PMID 27690762 ↗ Dec 2016
Modality	Vaccine	“Fluarix vaccine” NCT00100399 ↗
Route	Intramuscular	“Fluarix) administered intramuscularly” NCT00100399 ↗