Delving into the Latest Updates on GSK-576389A with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

FluAS25 adjuvanted influenza vaccine, FluAS25 adjuvanted inluenza vaccine, Seasonal influenza virus vaccine

+ [3]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Influenza, Human

Originator Organization

GSK Plc

Active Organization-

Inactive Organization

GSK Plc

License Organization-

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this study, the subjects previously enrolled in study 107973 will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 107973 (NCT00386113) are eligible for participation in this study.

Start Date23 Oct 2007

Sponsor / Collaborator

GSK Plc

NCT00529516

/ CompletedPhase 3

Observer Blind Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals Influenza Vaccine GSK576389A Administered to Adults Over 65 Years Previously Vaccinated With the Same Vaccine, Compared to Fluarix™

Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for participation in this study.

Start Date15 Oct 2007

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with GSK-576389A

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100 Translational Medicine associated with GSK-576389A

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100 Patents (Medical) associated with GSK-576389A

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33

Literatures (Medical) associated with GSK-576389A

07 Jul 2025·Journal of Experimental Medicine

Vaccination against influenza viruses annually: Renewing or narrowing the protective shield?

Review

Author: Matz, Hanover C. ; Ellebedy, Ali H.

Annual vaccines are recommended for the seasonal influenza virus. While yearly updates to the vaccine are necessary due to the constant evolution of influenza viruses, some studies have suggested repeat vaccination may result in a reduction in vaccine effectiveness in subsequent years. This review examines the available evidence that repeated annual influenza virus vaccination may have effects on future vaccine responses, and it synthesizes the available data with studies that may indicate potential immunological mechanisms underlying these effects. The goal is to examine the available literature to determine whether these mechanisms can be subverted to improve seasonal influenza virus vaccine efficacy.

01 Apr 2025·Vaccine

Next-generation seasonal influenza virus vaccines need a neuraminidase component

Article

Author: Krammer, Florian

01 May 2024·Science Translational Medicine

Vaccination with antigenically complex hemagglutinin mixtures confers broad protection from influenza disease

Article

Author: Macintyre, Andrew N. ; Heaton, Nicholas S. ; Berry, Madison ; Spreng, Rachel L. ; Stover, Erica L. ; Luo, Zhaochen ; Soderblom, Erik J. ; Waitt, Greg ; Miranda, Hector A. ; Spurrier, M. Ariel ; Wiehe, Kevin ; Burke, Kaitlyn N.

Current seasonal influenza virus vaccines induce responses primarily against immunodominant but highly plastic epitopes in the globular head of the hemagglutinin (HA) glycoprotein. Because of viral antigenic drift at these sites, vaccines need to be updated and readministered annually. To increase the breadth of influenza vaccine–mediated protection, we developed an antigenically complex mixture of recombinant HAs designed to redirect immune responses to more conserved domains of the protein. Vaccine-induced antibodies were disproportionally redistributed to the more conserved stalk of the HA without hindering, and in some cases improving, antibody responses against the head domain. These improved responses led to increased protection against homologous and heterologous viral challenges in both mice and ferrets compared with conventional vaccine approaches. Thus, antigenically complex protein mixtures can at least partially overcome HA head domain antigenic immunodominance and may represent a step toward a more universal influenza vaccine.

100 Deals associated with GSK-576389A

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 3	Norway	GSK Plc	15 Oct 2007
Influenza, Human	Phase 3	United States	GSK Plc	15 Oct 2007
Influenza, Human	Phase 3	Germany	GSK Plc	15 Oct 2007
Influenza, Human	Phase 3	Belgium	GSK Plc	15 Oct 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00538213 (CTgov)	Phase 2	Influenza, Human	133	GSK Bio's Influenza Vaccine GSK576389A (Adjuvanted Influenza Vaccine GSK576389A Group)	dfsnkdciui(pdcdlxegim) = dbepozdily omeprctitu (qhnjghgkjm, kmxhyltkhx - uptnkjbbnl) View more	-	05 Sep 2012
				Fluarix™ (Fluarix Elderly Group)	dfsnkdciui(pdcdlxegim) = zzkciyidei omeprctitu (qhnjghgkjm, wcrqscaihs - qhpeiecqmi) View more
NCT00538473 (CTgov)	Phase 2	Influenza, Human	68	GSK Biologicals' influenza vaccine GSK576389A (FluAS25 (GSK576389A) Group)	(qxrnbqbmix) = kgnyfpfwia skjmjctxeh (cjdgcykknc, lygetqjlcd - lvwjkzzngb) View more	-	27 Jul 2012
				Fluarix™ (Fluarix Group)	(qxrnbqbmix) = cncmowtgqy skjmjctxeh (cjdgcykknc, qbcwqkdrzz - yirpclabks) View more
NCT00529516 (CTgov)	Phase 3	Influenza, Human	1,252	GSK Biologicals Influenza Vaccine GSK576389A (FluAS25 Group)	(frnmrzqmfb) = injctjjqtd qycvqhqupz (flbunafbdd, faowqrvqlc - wprzceltyn) View more	-	30 May 2012
				Fluarix (Fluarix ≥ 65 Years Age Group)	(frnmrzqmfb) = loyzhvbxhc qycvqhqupz (flbunafbdd, upvgguosiw - rjexpwxkad) View more
NCT00633074 (CTgov)	Phase 2	Influenza, Human	720	Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A) (Thiomersal-free FluAS25 Adjuvanted Vaccine Group)	vijhkwvfkx(yetktnxydq) = gbdkvdmljq wofzwmddhr (lqszytrzly, ztknfkovrs - sbvkkoakmv) View more	-	28 May 2012
				Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A) (Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group)	vijhkwvfkx(yetktnxydq) = adepnhvstj wofzwmddhr (lqszytrzly, rrykaliyny - rkladvrovv) View more
NCT00532298 (CTgov)	Phase 2	Influenza, Human	1,596	GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season] (GSK576389A- 2006/2007 Season - 1 Container Group)	psktfrowpj(pflwaxcbcq) = jmnmzcdxcx bzdhpyccwi (eiagcgvtpr, eukrosphbj - wltplbmcps) View more	-	22 May 2012
				GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season] (GSK576389A - 2006/2007 Season - 2 Containers Group)	psktfrowpj(pflwaxcbcq) = riptputhkw bzdhpyccwi (eiagcgvtpr, lgjsxtdmfl - kajdxcslnd) View more