Delving into the Latest Updates on Quadrivalent influenza virus vaccine(SK Chemicals Co. Ltd.) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

NBP 607-quadrivalent, Quadrivalent inactivated cell culture derived influenza vaccine, SKYCellflu quadrivalent

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Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Influenza, Human

Inactive Indication-

Originator Organization

SK Chemicals Co. Ltd.

Active Organization

SK Chemicals Co. Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

KR (26 Dec 2015),

Influenza, Human

Regulation-

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This study assesses immunogenicity and safety of NBP607-QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease. Total of 675 subjects or above (450 subjects for NBP607-QIV arm and 225 subjects for Agrippal arm) of 6 to 35 months of age are enrolled, and each subject is administered with single or two doses of vaccines depending on previous vaccination history.

Start Date25 Oct 2018

Sponsor / Collaborator

SK bioscience Co., Ltd.

NCT03020628 / CompletedPhase 3

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of 'NBP607-QIV(Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine)' in Children Aged 6~35 Months

This study is a multi-center, randomized, double-blind Phase III Clinical trial. The purpose of this study is to assess the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compare to the trivalent cell culture-derived influenza vaccine in children aged 6
35 months.

Start Date01 Oct 2016

Sponsor / Collaborator

SK Chemicals Co. Ltd.

NCT02806804 / Unknown statusPhase 3IIT

Safety and Immunogenicity Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged Years 3-60

This study evaluates the safety and immunogenicity of the quadrivalent influenza virus vaccine in healthy people aged years 3-60.Subjects will be randomly divided into 3 groups,receiving the test vaccine, commercially available trivalent influenza vaccine and trivalent influenza vaccine containing new influenza B component respectively. Each group has 800 subjects,2400 in total.

Start Date01 May 2016

Sponsor / Collaborator-

100 Clinical Results associated with Quadrivalent influenza virus vaccine(SK Chemicals Co. Ltd.)

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100 Translational Medicine associated with Quadrivalent influenza virus vaccine(SK Chemicals Co. Ltd.)

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100 Patents (Medical) associated with Quadrivalent influenza virus vaccine(SK Chemicals Co. Ltd.)

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13

Literatures (Medical) associated with Quadrivalent influenza virus vaccine(SK Chemicals Co. Ltd.)

01 Jan 2023·Vaccine

Factors associated with humoral immune response in older adults who received egg-free influenza vaccine

Article

Author: Moehling Geffel, Krissy ; Kim, Sara S ; Zimmerman, Richard K ; Susick, Michael ; Levine, Min Z ; Flannery, Brendan ; Williams, Katherine V ; Patricia Nowalk, Mary ; Alcorn, John F

BACKGROUNDImmune responses to influenza vaccination tend to be lower among older, frequently vaccinated adults. Use of egg-free influenza vaccines is increasing, but limited data exist on factors associated with their immunogenicity in older adults.METHODSCommunity-dwelling older adults ≥ 56 years of age were enrolled in a prospective, observational study of immunogenicity of 2018-2019 influenza vaccine. Hemagglutination inhibition (HAI) antibody titers were measured pre-vaccination (Day 0) and four weeks after vaccination (Day 28) to calculate geometric mean titers, seropositivity (HAI titers ≥ 1:40), seroconversion (fourfold rise in HAI titer with post-vaccination titer ≥ 1:40) and geometric mean fold rise (GMFR). Linear regression models assessed the association of predictors of GMFR for each vaccine antigen.RESULTSAmong 91 participants who received egg-free influenza vaccines, 84 (92.3 %) received quadrivalent recombinant influenza vaccine (RIV4, Flublok, Sanofi Pasteur), and 7 (7.7 %) received quadrivalent cell culture-based influenza vaccine (ccIIV4, Flucelvax, Seqirus). Pre-vaccination seropositivity was 52.8 % for A(H1N1), 94.5 % for A(H3N2), 61.5 % for B/Colorado and 48.4 % for B/Phuket. Seroconversion by antigen ranged from 16.5 % for A(H1N1) and B/Colorado to 37.4 % for A(H3N2); 40 participants failed to seroconvert to any antigen. Factors independently associated with higher GMFR in multivariable models included lower pre-vaccination HAI antibody titer for A(H1N1), B/Colorado and B/Phuket, and younger age for A(H1N1).CONCLUSIONOverall pre-vaccination seropositivity was high and just over half of the cohort seroconverted to ≥ 1 vaccine antigen. Antibody responses were highest among participants with lower pre-vaccination titers. Among older adults with high pre-existing antibody titers, approaches to improve immune responses are needed.

01 Aug 2022·BMJ Open

Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans

Article

Author: Rosen, Craig S ; Burn, Adam S ; Zeitzer, Jamie M ; Mathersul, Danielle C ; Wong, Melinda ; Hernandez, Beatriz ; Tang, Julia S ; Lazzeroni, Laura C ; Avery, Tim ; Bayley, Peter J ; Schulz-Heik, R Jay ; Seppälä, Emma M

ObjectiveTest whether Sudarshan Kriya Yoga (SKY) was non-inferior to cognitive processing therapy (CPT) for treating symptoms of post-traumatic stress disorder (PTSD) among veterans via a parallel randomised controlled non-inferiority trial.SettingOutpatient Veterans Affairs healthcare centre.Participants85 veterans (75 men, 61% white, mean age 56.9) with symptoms of PTSD participated between October 2015 and March 2020: 59 participants completed the study.InterventionsSKY emphasises breathing routines and was delivered in group format in a 15-hour workshop followed by two 1-hour sessions per week for 5 weeks. CPT is an individual psychotherapy which emphasises shifting cognitive appraisals and was delivered in two 1-hour sessions per week for 6 weeks.MeasuresThe primary outcome measure was the PTSD Checklist-Civilian Version (PCL-C). The secondary measures were the Beck Depression Inventory-II (BDI-II) and Positive and Negative Affect Scale (PANAS).ResultsMean PCL-C at baseline was 56.5 (±12.6). Intent-to-treat analyses showed that PCL-C scores were reduced at 6 weeks (end of treatment) relative to baseline (SKY, −5.6, d=0.41, n=41: CPT, −6.8, d=0.58, n=44). The between-treatment difference in change scores was within the non-inferiority margin of 10 points (−1.2, 95% CI −5.7 to 3.3), suggesting SKY was not inferior to CPT. SKY was also non-inferior at 1-month (CPT–SKY: −2.1, 95% CI −6.9 to 2.8) and 1-year (CPT–SKY: −1.8, 95% CI −6.6 to 2.9) assessments. SKY was also non-inferior to CPT on the BDI-II and PANAS at end of treatment and 1 month, but SKY was inferior to CPT on both BDI-II and PANAS at 1 year. Dropout rates were similar (SKY, 27%, CPT, 34%: OR=1.36, 95% CI 0.51 to 3.62, p=0.54).ConclusionsSKY may be non-inferior to CPT for treating symptoms of PTSD and merits further consideration as a treatment for PTSD.Trial registration numberNCT02366403.

01 Jan 2022·Multiple Sclerosis and Related DisordersQ3 · MEDICINE

Quantifying the relationship between disability progression and quality of life in patients treated for NMOSD: Insights from the SAkura studies

Q3 · MEDICINE

Article

Author: Szczechowski, Lech ; Maio, D Di ; Klingelschmitt, Gaelle ; Costantino, Cristina ; Haycox, Alan R ; von Büdingen, H Christian ; Damonte, Elisabetta ; Levy, Michael ; Wallenstein, Gene ; Becker, Ursula

BACKGROUNDTo date, no specific scales have been developed to explore the impact of neuromyelitis optica spectrum disorder (NMOSD)-related disability on quality of life (QoL). The Expanded Disability Status Scale (EDSS) and the EuroQol 5-dimensions (EQ-5D) have been used to assess disability and QoL, respectively, in patients with NMOSD. However, there is limited evidence surrounding their use in this condition. We compared EDSS and EQ-5D data across two clinical trials to quantify the relationship between disability and QoL in patients with NMOSD.METHODSSAkuraSky (NCT02028884) and SAkuraStar (NCT02073279) were Phase 3, multicenter, randomized, international, double-blind, placebo-controlled, parallel-assignment studies of satralizumab, administered in combination with baseline immunosuppressants (SAkuraSky) or as monotherapy (SAkuraStar). EDSS and EQ-5D were assessed at baseline and at 24-week intervals thereafter. The relationship between disability and QoL was assessed by estimating EQ-5D utilities (UK tariff) for each incremental EDSS category. A repeated-measures linear model was used to regress health utilities on EDSS score-derived health states.RESULTSOverall, 176 patients underwent at least one EDSS assessment and completed an EQ-5D survey and were included in this analysis. There was a clear association between mean EQ-5D score and EDSS score, with decreases in QoL being observed at each incremental increase in disability. The relationship between EDSS and EQ-5D score remained consistent across the different treatment groups.CONCLUSIONSThese results, generated from high-quality clinical trial data, demonstrated a strong and consistent relationship between disability and QoL in patients with NMOSD.

100 Deals associated with Quadrivalent influenza virus vaccine(SK Chemicals Co. Ltd.)

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External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Influenza, Human	KR	SK Chemicals Co. Ltd.	26 Dec 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Discovery	-	SK Chemicals Co. Ltd.	01 Nov 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02467842 (CTgov)	Phase 3	Influenza, Human	1,503	NBP607-QIV (NBP607-QIV)	xjaxxetosz(ampzflujuw): GMR (TIV/QIV) = 0.88 (95% CI, 0.82 - 0.95) View more	-	08 May 2020
				NBP607-Y (NBP607-Y)
NCT02467842 (Pubmed)	Phase 3	Influenza, Human	1,503	NBP607-QIV	xditaqvwwi(zxlvvbmfox) = xdiqqnqqyi pyutyphfui (kkffzckrwk ) View more	-	03 Jul 2017
				NBP607-QIV (NBP607-Y)	xditaqvwwi(zxlvvbmfox) = wwksdzjtwp pyutyphfui (kkffzckrwk ) View more