Delving into the Latest Updates on Pandemic influenza vaccine (H1N1)(GlaxoSmithKline Biologicals SA) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

Arepanrix H1N1, H1N1 pandemic influenza virus vaccine (GSK), Influenza A H1N1 split virion vaccine (GSK)

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Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Influenza, Human

Originator Organization

GlaxoSmithKline Biologicals SA

Active Organization-

Inactive Organization

GlaxoSmithKline Biologicals SA

GSK Plc

Drug Highest PhaseWithdrawn

First Approval Date

European Union (23 Mar 2010),

Influenza, Human

Regulation-

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The goal of the study is to assess the risk of occurrence of narcolepsy following the administration of inactivated (AS03) adjuvanted A/H1N1 pandemic influenza vaccine in the province of Quebec, Canada, using different case definitions and time intervals to disease onset, while controlling for potential confounding variables such as age, gender, season and, when possible, A/H1N1 pandemic influenza infection. Another aim is to describe the epidemiology and clinical features of narcolepsy cases with onset during the period January 1st, 2009 to December 31, 2010 in the population of Quebec.

Start Date01 Jun 2011

Sponsor / Collaborator

Hopital du Sacré-Coeur de Montréal

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NCT01161160

/ CompletedPhase 2

An Observer-blind Safety and Immunogenicity Study of GSK Biologicals' A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340272A in Children 3 to Less Than 10 Years Old

This study is designed to characterize the safety and immunogenicity of pandemic influenza (H1N1) candidate vaccines GSK2340274A and GSK234072A in children 3 to less than 10 years old.

Start Date01 Jul 2010

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Pandemic influenza vaccine (H1N1)(GlaxoSmithKline Biologicals SA)

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100 Translational Medicine associated with Pandemic influenza vaccine (H1N1)(GlaxoSmithKline Biologicals SA)

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100 Patents (Medical) associated with Pandemic influenza vaccine (H1N1)(GlaxoSmithKline Biologicals SA)

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64

Literatures (Medical) associated with Pandemic influenza vaccine (H1N1)(GlaxoSmithKline Biologicals SA)

01 Aug 2019·Pediatric Infectious Disease JournalQ4 · MEDICINE

What We Need to Know to be Ready for the Next Pandemic

Q4 · MEDICINE

Review

Author: Lambert, Paul-Henri ; Black, Steven ; Edwards, Kathryn

After the initial identification of the H1N1 pandemic influenza strain in Mexico in April 2009 and its subsequent global spread, several monovalent influenza vaccines were developed as part of the pandemic response. Three of these vaccines, Pandemrix, Arepanrix and Focetria were adjuvanted. One of these, the AS03-adjuvanted Pandemrix vaccine, was primarily used in Europe. Following widespread Pandemrix vaccine administration in Scandinavia, an increased risk of narcolepsy was noted in observational studies. Subsequently, this increased risk was also reported in other European countries as well. In contrast, studies from Canada of a similar AS03-adjuvanted vaccine, Arepanrix, did not demonstrate a similar increased risk of narcolepsy. No studies have identified an increased risk of narcolepsy following the MF59-adjuvanted Focetria vaccine. For many potential pandemic influenza strains, adjuvants might be required to solicit a protective immune response. Thus, it is critical that we understand the nature of the association between adjuvanted vaccine receipt and narcolepsy. Here, we present a potential hypothesis for narcolepsy seen during the 2009 H1N1 pandemic in AS03-adjuvanted influenza vaccine recipients.

01 May 2019·VaccineQ3 · MEDICINE

Safety of AS03-adjuvanted influenza vaccines: A review of the evidence

Q3 · MEDICINE

Review

Author: Doherty, T Mark ; Cohet, Catherine ; Bekkat-Berkani, Rafik ; Bauchau, Vincent ; Innis, Bruce L ; van der Most, Robbert ; Rappuoli, Rino ; Garçon, Nathalie ; Schuind, Anne ; Tavares Da Silva, Fernanda

Clinical and post-licensure data have demonstrated that AS03-adjuvanted inactivated split virion vaccines, many with reduced antigen content, are effective against influenza infection. The objective of this review is to provide a comprehensive assessment of the safety of trivalent seasonal, monovalent pre-pandemic and pandemic AS03-adjuvanted influenza vaccines, based on non-clinical, clinical and post-licensure data in various populations. Non-clinical studies on local tolerance, toxicology and safety pharmacology did not raise any safety concerns with AS03 administered alone or combined with various influenza antigens. Data from clinical trials with over 55,000 vaccinated subjects showed that AS03-adjuvanted influenza vaccines were generally well tolerated and displayed an acceptable safety profile, although the power to detect rare events was limited. Approximately 90 million doses of A/H1N1pdm09 pandemic influenza vaccines (Pandemrix and Arepanrix H1N1) were administered worldwide, which contributed post-licensure data to the collective safety data for AS03-adjuvanted influenza vaccines. An association between Pandemrix and narcolepsy was observed during the A/H1N1pdm09 pandemic, for which a role of a CD4 T cell mimicry sequence in the haemagglutinin protein of A/H1N1pdm09 cannot be excluded. Provided that future AS03-adjuvanted influenza vaccines do not contain this putative mimicry sequence, this extensive safety experience supports the further development and use of AS03-adjuvanted inactivated split virion candidate vaccines against seasonal and pandemic influenza infections.

01 Jul 2018·Emerging Infectious DiseasesQ2 · MEDICINE

Registry Cohort Study to Determine Risk for Multiple Sclerosis after Vaccination for Pandemic Influenza A(H1N1) with Arepanrix, Manitoba, Canada

Q2 · MEDICINE

ArticleOA

Author: Bozat-Emre, Songul ; Marrie, Ruth Ann ; Mahmud, Salaheddin M. ; Mostaço-Guidolin, Luiz C.

To investigate a potential risk for multiple sclerosis (MS) after vaccination with Arepanrix, the GlaxoSmithKline AS03-adjuvanted influenza A(H1N1)pdm09 vaccine, we used the provincewide immunization registry for Manitoba, Canada, to match 341,347 persons vaccinated during the 2009 pandemic to 485,941 unvaccinated persons on age, sex, address, and a propensity score measuring the probability of vaccination. We used a previously validated algorithm to identify MS cases from provincial hospital, physician, and prescription drug claims databases. After 12 months of follow-up, the age-adjusted incidence rate of MS was 17.7 cases per 100,000 person-years in the Arepanrix cohort and 24.2 per 100,000 in the unvaccinated cohort. The corresponding adjusted hazard ratio was 0.9. We observed similar patterns when we measured incidence over the entire follow-up period. The AS03 adjuvant, a candidate for inclusion in future pandemic vaccines, does not appear to increase the short-term risk for MS when included in influenza vaccines.

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News (Medical) associated with Pandemic influenza vaccine (H1N1)(GlaxoSmithKline Biologicals SA)

18 Jul 2022

·endpts.com

GSK nets a deal with Canadian government for flu vaccine manufacturing

While Covid-19 and monkeypox manufacturers are getting more ontracts, the Canadian government is still concerned with the flu, especially as its season will soon be upon North America in a few months. Last Friday, GSK announced an agreement with the Canadian government to manufacture pandemic and seasonal influenza vaccines. The four-year agreement, which extends through March 2026, includes GSK supplying as many as 80 million doses of Arepanrix, an adjuvanted pandemic flu vaccine, in case there is an influenza pandemic. The deal will also have GSK produce a minimum of 4 million doses per year of the seasonal flu vaccine Flulaval Tetra. Both vaccines will be manufactured at its 230,000-square-foot facility in Sainte-Foy, Quebec.

VaccineCollaborate

100 Deals associated with Pandemic influenza vaccine (H1N1)(GlaxoSmithKline Biologicals SA)

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External Link

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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	Discovery	European Union	GlaxoSmithKline Biologicals SA	23 Mar 2010
Influenza, Human	Discovery	Norway	GlaxoSmithKline Biologicals SA	23 Mar 2010
Influenza, Human	Discovery	Iceland	GlaxoSmithKline Biologicals SA	23 Mar 2010
Influenza, Human	Discovery	Liechtenstein	GlaxoSmithKline Biologicals SA	23 Mar 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01003418 (CTgov)	Phase 2	Influenza, Human	8	GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine+Prevenar+Infanrix™-IPV/Hib (GSK2340272A Group 1)	(linrwzniov) = rheuedoqff elpbqceldt (moyqhpttln, ufhnnuvtxv - angoelvpsb) View more	-	15 Feb 2019
				GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine+Prevenar+Infanrix™-IPV/Hib (GSK2340272A Group 2)	(linrwzniov) = vbusdndpqv elpbqceldt (moyqhpttln, ubqxtmuaef - skizeltcoj) View more
NCT00992511 (CTgov)	Phase 3	Influenza, Human	300	GSK investigational vaccine GSK2340272A (GSK2340272A New 1D Group)	hvtclzxtor(rtrbhlxkpz) = dhtqrwnilg ssxttxnivg (lgcqhojmrw, hvdvwjuwlh - vewlrzofvc) View more	-	31 Jan 2019
				GSK investigational vaccine GSK2340272A (GSK2340272A New 2D Group)	hvtclzxtor(rtrbhlxkpz) = yybkskstlq ssxttxnivg (lgcqhojmrw, guqucyawtp - rhtiyusihr) View more
NCT00975884 (CTgov)	Phase 3	Influenza, Human	312	GSK investigational vaccine GSK2340272A (GSK2340272A (D21) GROUP)	iuinvzdyql(fdkvfqnojv) = zcfwwhvkgx okxvrxolmb (mlaszhmhun, ljswdnstcr - fcpxovgewj) View more	-	28 Jan 2019
				GSK investigational vaccine GSK2340272A (GSK2340272A (M6) GROUP)	iuinvzdyql(fdkvfqnojv) = aytuingiiy okxvrxolmb (mlaszhmhun, vpegqxtaxi - ylppatqjpm) View more
NCT00989612 (CTgov)	Phase 2	Influenza, Human	100	Influenza investigational vaccine GSK2340274A	ohzzdvmztf(cvotbqbnqq) = psmqtsreud zlpgdgoaph (tmxmsfemke, uimvhvrhcw - dibmermsof) View more	-	16 Jan 2019
NCT00951041 (CTgov)	Phase 2	Influenza, Human	130	GSK investigational vaccine GSK2340272A (GSK2340272A Group)	yomstdozem(jckynvkvco) = flbxvyqswh ywwujsidig (dzrkgbqbsn, afbtihqjef - hsqarwlifj) View more	-	26 Nov 2018
				GSK investigational vaccine GSK2340269A (GSK2340269A Group)	yomstdozem(jckynvkvco) = dpzklolxht ywwujsidig (dzrkgbqbsn, tmiwapyueb - ndtgdoppeb) View more
NCT00968526 (CTgov)	Phase 3	Influenza, Human	240	GSK investigational vaccine GSK2340272A (GSK2340272A 1D Group)	oueisnawby(lxfuxxpcbs) = qlyufvxtlo gzybyvpybd (lqqpvfpvxa, arvhrmnqpo - ciynobmafx) View more	-	18 Sep 2018
				GSK investigational vaccine GSK2340272A (GSK2340272A 2D Group)	oueisnawby(lxfuxxpcbs) = xojdfhpbeb gzybyvpybd (lqqpvfpvxa, znijvlreci - izfelbakwv) View more
NCT00979407 (CTgov)	Phase 3	Influenza, Human	336	Influenza vaccine GSK2340272A (GSK2340272A GROUP)	oxrfixnbjc(mjaovekuyf) = uahtlnmtxp gmfzratsmn (lgvomkobcs, tstdwvxqao - ipdfvzwsul) View more	-	06 Aug 2018
				Influenza vaccine GSK2340274A (GSK2340274A GROUP)	oxrfixnbjc(mjaovekuyf) = tfzdhatrti gmfzratsmn (lgvomkobcs, limociiffq - zmhkgfhagm) View more
NCT00989287 (CTgov)	Phase 3	Influenza, Human	131	GSK2340272A (GSK2340272A Group)	kavzqmjjrr(ajywvruigk) = xswtzneqks nqmteptnxd (dlaskktvvo, kskxujizfi - cuqvqwvlhu) View more	-	05 Mar 2018
				GSK2340269A (GSK2340269A Group)	kavzqmjjrr(ajywvruigk) = wxvvmothvt nqmteptnxd (dlaskktvvo, bafdozosrr - wngvrdaifb) View more
NCT00964158 (CTgov)	Phase 3	Influenza, Human	210	GSK2340272A vaccine (GSK2340272A Group)	byuwlkkiqu(yucofokiag) = zaxqawgpuf ybiscwxdze (yeavfmmtez, smcituaflf - qxtrnvhfbp) View more	-	19 Feb 2018
				GSK2340272A (3-5Y) (GSK2340272A (3-5Y) Group)	iiqckmbnbs(uzdowzwiez) = feluovrmjv uktlykfmsr (qxfyvfayrz, lugbdcedvl - jrrlfzobho) View more
NCT00968539 (CTgov)	Phase 3	Influenza, Human	130	GSK investigational vaccine GSK2340272A (GSK2340272A Group)	jtmalornjw(olcqioyvbm) = nuboxbgivx vkvwufhkgg (iqnmtgjiek, vtfthkispe - dqxcecdekl) View more	-	18 Dec 2017
				GSK investigational vaccine GSK2340269A (GSK2340269A Group)	dwosqsdykk(nfalcgkouu) = gwevbmwpji siznbznqbq (jkvflpyrix, nqentpkjis - bmcbbzrrax) View more