Delving into the Latest Updates on Influenza virus vaccine(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Multivalent vaccine

Synonyms

Fluarix Trivalent, Fluarix-VB, Inactivated Split Influenza Vaccine

+ [6]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Influenza A virus infectionInfluenza, HumanOrthomyxoviridae Infections

Inactive Indication-

Originator Organization

GSK Plc

Active Organization

GlaxoSmithKline Biologicals SA

Inactive Organization

GSK Plc

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (01 Jan 2002),

Influenza A virus infectionInfluenza, HumanOrthomyxoviridae Infections

Regulation-

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Author: Schaefers, Kristin ; Hicks, Bryony ; Miller, Jacqueline ; Rudden, Sinead ; Ensz, David ; Ananworanich, Jintanat ; Soens, Mieke ; Avanesov, Andrei ; Park, Yoonyoung ; Essink, Brandon ; Ma, Chong ; Llapur, Conrado ; Hall, Kristi ; Zhou, Honghong ; Du, Evelyn ; Fierro, Carlos ; Kandinov, Boris ; Guo, Jia ; Zheng, Lingyi ; Vakil, Jignesh ; Huang, Wenmei ; Nachbagauer, Raffael ; Pucci, Alicia

The safety, immunogenicity, and efficacy of the original formulation of the investigational mRNA-1010 vaccine for seasonal influenza were investigated in two randomized, active-controlled, phase 3 trials in adults (NCT05415462 and NCT05566639), and the results were used to evaluate hemagglutination inhibition (HAI) titers as correlates of risk and protection against influenza-like illness. mRNA-1010 (50-µg) demonstrated an acceptable reactogenicity and safety profile among the >14,000 adult participants vaccinated in both trials. The efficacy profile of mRNA-1010 was generally reflective of immunogenicity findings, with higher immune responses against influenza A strains and lower responses against influenza B strains relative to an active comparator (licensed inactivated influenza vaccine). An analysis of HAI titers as a correlate of protection against influenza infection provided support for its use as a surrogate endpoint for mRNA-1010, similar to licensed influenza vaccines. These findings support further optimization and development of mRNA-1010 against seasonal influenza.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Effectiveness of inactivated influenza vaccine against laboratory-confirmed influenza in elderly Chinese patients with diabetes: A test-negative design case-control study

Article

Author: Yang, Tianchi ; Chen, Zhengyan

Vaccination coverage for influenza among diabetic populations remains suboptimal. Various factors contribute to this low vaccination rate, with a prominent issue being skepticism among potential vaccine recipients regarding vaccine effectiveness. We conducted a retrospective test-negative case-control study among diabetic patients aged 60 years and older in Ningbo, Zhejiang Province, China, spanning for four influenza seasons from 2018-19 to 2021-22. A total of 2,204 elderly patients were tested for influenza virus nucleic acid or antigen during the study period. After applying exclusion criteria, 199 influenza-positive cases and 199 matched influenza-negative controls were included in the final analysis. Vaccine effectiveness (VE) was estimated using an unconditional multiple logistic regression model, adjusted for age, gender, household registration and underlying health status. VE was calculated as (1-odds ratio(OR)) × 100%. Overall, the adjusted VE against laboratory-confirmed influenza from inactivated influenza vaccines over the study period was 59.4% (95%CI, 36.3% to 74.4%). VE varied across seasons, with the highest observed in the 2020-21 season and the lowest in the 2019-20 season. Importantly, repeated vaccination did not diminish vaccine effectiveness (OR = 1.2; 95% CI: 0.6 to 2.5). These findings provide a robust basis for recommending annual influenza vaccination among all elderly individuals with diabetes, absent any known contraindications.

01 Apr 2025·Clinical Gastroenterology and Hepatology

AGA Clinical Practice Update on Noncolorectal Cancer Screening and Vaccinations in Patients With Inflammatory Bowel Disease: Expert Review

Review

Author: Kane, Sunanda ; Hashash, Jana G ; Long, Millie ; Caldera, Freddy

DESCRIPTIONThe aim of this American Gastroenterological Association (AGA) Clinical Practice Update (CPU) is to provide Best Practice Advice statements for gastroenterologists and other healthcare providers who provide care to patients with inflammatory bowel disease (IBD). The focus is on IBD-specific screenings (excluding colorectal cancer screening, which is discussed separately) and vaccinations. We provide guidance to ensure that patients are up to date with the disease-specific cancer screenings and vaccinations, as well as advice for mental health and general well-being.METHODSThis expert review was commissioned and approved by the AGA CPU Committee and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPU Committee and external peer review through standard procedures of Clinical Gastroenterology and Hepatology. The Best Practice Advice statements were drawn from reviewing existing literature combined with expert opinion to provide practical advice on the screening for noncolorectal cancers and vaccinations in patients with IBD. Because this was not a systematic review, formal rating of the quality of evidence or strength of the presented considerations was not performed. Best Practice Advice Statements BEST PRACTICE ADVICE 1: All adult patients with IBD should receive age-appropriate cancer screening. BEST PRACTICE ADVICE 2: Adult women with IBD should follow age-appropriate screening for cervical dysplasia. Data are insufficient to determine whether patients receiving combined immunosuppression or thiopurines require more frequent screening. Shared decision making and individual risk stratification are encouraged. BEST PRACTICE ADVICE 3: All adult patients with IBD should follow skin cancer primary prevention practices by avoiding excessive exposure to the sun's ultraviolet radiation. Patients on immunomodulators, anti-tumor necrosis factor biologic agents, or small molecules should undergo yearly total body skin exam. Patients with any history of thiopurine use should continue with yearly total body skin exam even after thiopurine cessation. BEST PRACTICE ADVICE 4: At every colonoscopy, a thorough perianal and anal examination should be performed. Special attention should be made to inspection of the anal canal of patients with perianal Crohn's disease, with anal stricture, with human papillomavirus, with human immunodeficiency virus, and who engage in anoreceptive intercourse. BEST PRACTICE ADVICE 5: Gastroenterology clinicians should discuss age-appropriate vaccines with adult patients who have IBD and share responsibility with primary care providers for administering these vaccines. Patients with IBD should follow the adult immunization schedule advised by the Centers for Disease Control and Prevention (CDC) for all vaccines with the exception of live vaccines; Patients receiving immune-modifying agents should be counseled against receiving live vaccines; Immunization history to the 2 live pediatric vaccines, varicella and measles, mumps, and rubella vaccine series, is presumptive evidence of immunity. All adults 18 to 26 years of age should receive human papillomavirus vaccine series, and those between 27 and 45 of age years should be vaccinated if they are likely to have a new sexual partner. BEST PRACTICE ADVICE 6: Inactivated vaccines are safe in patients with IBD, and their administration is not associated with exacerbation of IBD activity. We suggest that patients receive vaccines at the earliest opportunity and preferably be off corticosteroids or at the lowest tolerable corticosteroid dose. BEST PRACTICE ADVICE 7: All adult patients with IBD should be evaluated for latent hepatitis B infection. Patients who have previously completed a full hepatitis B vaccine series but are not seroprotected (hepatitis B surface antibody [anti-HBs] <10 mIU/mL) should receive a single challenge dose of hepatitis B vaccine; Four to 8 weeks after this challenge dose, their anti-HBs levels should be measured to evaluate for an amnestic response. An amnestic response, indicated by an anti-HBs level ≥10 mIU/mL (seroprotection), suggests immunologic memory, and no further doses are needed. If no amnestic response is observed, the patient should complete a second full 2- or 3-dose series of hepatitis B vaccination. BEST PRACTICE ADVICE 8: All adult patients with IBD should receive an annual inactivated influenza vaccine. Patients receiving anti-tumor necrosis factor monotherapy or who have undergone a solid organ transplant recipients can benefit from a high-dose influenza vaccine. Adults 65 years of age and older should receive a high-dose, recombinant, or adjuvanted influenza vaccine. Live attenuated intranasal vaccines should be avoided. BEST PRACTICE ADVICE 9: All adult patients with IBD 19 to 64 years of age should receive an initial pneumococcal vaccine, with an subsequent second pneumococcal vaccine administered at 65 years of age and older. BEST PRACTICE ADVICE 10: All adult patients with IBD who are 60 years of age and older should receive a respiratory syncytial virus vaccine. There is no preference for any of the available respiratory syncytial virus vaccines. BEST PRACTICE ADVICE 11: All adult patients 19 years of age and older receiving immune-modifying therapies, or with plans to initiate immune-modifying therapies, should receive a recombinant herpes zoster vaccine series, regardless of their prior varicella vaccination status. BEST PRACTICE ADVICE 12: Bone densitometry should be considered in patients with IBD, regardless of age, when risk factors for osteopenia and osteoporosis are present. These risk factors include low body mass index (<20 kg/m²), >3 months of cumulative corticosteroid exposure, current smoking, postmenopausal status, or hypogonadism. In the absence of other factors, bone densitometry should be considered for postmenopausal women and men 65 years or older. BEST PRACTICE ADVICE 13: All adult patients with IBD should be screened for depression and anxiety annually. Patients who screen positive for depression or anxiety should be referred to the appropriate specialist, be it their primary care physician or a mental health specialist.

100 Deals associated with Influenza virus vaccine(GlaxoSmithKline Plc)

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External Link

KEGG	Wiki	ATC	Drug Bank
D04536	-	J07BB01	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Influenza A virus infection	China	GlaxoSmithKline Biologicals SA	01 Jan 2002
Influenza, Human	China	GlaxoSmithKline Biologicals SA	01 Jan 2002
Orthomyxoviridae Infections	China	GlaxoSmithKline Biologicals SA	01 Jan 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Discovery	Germany	GSK Plc	01 Jul 2005

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00372255 (CTgov)	Phase 4	Influenza, Human	240	Influsplit SSW 2005/2006 vaccine (Influsplit SSW 2005/2006 6-9 Years Group)	rqeuxkzsxl(dgtljhhbay) = ritohvyqjj khshohasua (zrjqhqnbxk, satxdlzmit - evnlhkuchc) View more	-	06 May 2019
				Influsplit SSW 2005/2006 vaccine (Influsplit SSW 2005/2006 10-13 Years Group)	xejrylfuei(slatxhrmsb) = auwqowyofe osqfaddawf (fhqzlizare, cexzcnbawb - zscbrycoff) View more
NCT00377611 (CTgov)	Phase 4	Influenza, Human	3,054	Fluarix™ (Fluarix 50-64 Years Group)	ubcpojamjm(fjpizwgmxk) = vyahhpqxih rcsvoegkad (ugxovnuzmx, nmqbcxsnwx - zjvixfluwe) View more	-	09 Oct 2018
				Fluarix™ (Fluarix 65+ Years Group)	ubcpojamjm(fjpizwgmxk) = qupoureftq rcsvoegkad (ugxovnuzmx, ionngdvazx - iygqhrtdkl) View more
NCT01884519 (CTgov)	Phase 3	Influenza, Human	120	Fluarix/Influsplit SSW® (2013-2014 season) (Fluarix/Influsplit 18-60 Years Group)	senuxbgevq(wevdutkxch) = gqqgbypxva ivfmpcrutt (fxqwepplbm, nvxzurevxz - lacvgsgtjo) View more	-	01 Dec 2014
				Fluarix/Influsplit SSW® (2013-2014 season) (Fluarix/Influsplit > 60 Years Group)	senuxbgevq(wevdutkxch) = suabtbcevu ivfmpcrutt (fxqwepplbm, ivkbqrywbr - fhlwmdheno) View more
NCT01607112 (CTgov)	Phase 3	Influenza, Human	119	Fluarix/Influsplit SSW 2012-2013 (Fluarix/Influsplit 18-60 Years Group)	mnrucovifk(pjbiidueup) = spqnzmmpaa queyrqmics (fnxezjrvut, cfpsubzmhp - tkmgydfqri) View more	-	06 Dec 2013
				Fluarix/Influsplit SSW 2012-2013 (Fluarix/Influsplit > 60 Years Group)	mnrucovifk(pjbiidueup) = qqqmrtcufz queyrqmics (fnxezjrvut, qrzdbufdts - svlglypdyi) View more
NCT00693706 (CTgov)	Phase 1	Influenza, Human	200	Trivalent influenza vaccine GSK 138842A (GSK 1388442A Group)	(hyaxgujfog) = egorcusaug bmszvntuhi (jxvepfajbp, sjazgfsdad - mmxflqiijx) View more	-	12 Mar 2013
				Fluarix (Fluarix Group)	(hyaxgujfog) = kxthrklpbl bmszvntuhi (jxvepfajbp, ikivhnrrws - axoakoflbs) View more
NCT01190215 (CTgov)	Phase 4	Influenza, Human	77	FluarixTM (Fluarix Group)	bfgxjfvmdr(tbscifszay) = xzvczydvwp ynwtjimzon (ckmbmzamuc, fbzwflntgb - brmhwfldah) View more	-	13 Jul 2012
				HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old) (Havrix Group)	bfgxjfvmdr(tbscifszay) = iecvpyellp ynwtjimzon (ckmbmzamuc, mpkjqtfqzx - jfatcdgmzy) View more
NCT01196026 (CTgov)	Phase 4	Influenza, Human	162	Fluarix™ (Fluarix 6-11 Months Group)	anztnuaaca(sxgxthmqvg) = aivuighheq mfsgdfrkxm (qneegazwun, vznrocmtiq - uajsfvswys) View more	-	28 Jun 2012
				Fluarix™ (Fluarix 12-35 Months Group)	anztnuaaca(sxgxthmqvg) = vrgpvzvmft mfsgdfrkxm (qneegazwun, aqlvldhxzr - stwerkmuex) View more
NCT00453986 (CTgov)	Phase 3	Meningococcal Infections	1,352	Meningococcal vaccine GSK134612 (Nimenrix A Group)	mstrqbwopz(ystjfbixjx) = maisesziih ikhevvafio (bcmldunyvq, srlxdzdnnd - hggydhjqhk) View more	-	22 May 2012
				Meningococcal vaccine GSK134612 (Nimenrix B Group)	mstrqbwopz(ystjfbixjx) = oounjckqvv ikhevvafio (bcmldunyvq, jxaxdxekto - jsebfbelab) View more
NCT00985673 (CTgov)	Phase 2	Influenza, Human	611	Saline placebo+TIV+GSK2340273A+Seasonal trivalent influenza vaccine (Flulaval/Placebo/Unadjuvanted Arepanrix Group)	pdoabnjdzb(wuesuarnwq) = nmpenwkoyd fipaptvawg (psrceedppu, ankknqvtwb - snulegzpfm) View more	-	30 Jan 2012
				Saline placebo+TIV+GSK2340274A+Seasonal trivalent influenza vaccine (Flulaval/Placebo/Arepanrix Group)	pdoabnjdzb(wuesuarnwq) = xzyigyfpmp fipaptvawg (psrceedppu, uswvkorojw - fueptbanwh) View more
NCT00968890 (CTgov)	Phase 2	Influenza, Human	168	Placebo+Pandemrix (Influenza vaccine GSK2340272A)+Fluarix™ (Pandemrix+Fluarix and Pandemrix+Placebo)	jnookgtccf(ooyewxeueq) = eqexeftjcu dwfxmbbehw (dkiucifpup, dunshrajvf - peauiherfm) View more	-	16 Mar 2011
				Placebo+Pandemrix (Influenza vaccine GSK2340272A)+Fluarix™ (Pandemrix+Placebo and Pandemrix+Fluarix)	jnookgtccf(ooyewxeueq) = dmkdffpypd dwfxmbbehw (dkiucifpup, ozppjidftl - bkecixcgdr) View more