A Multinational, Comparative Phase III Clinical Trial to Assess the Efficacy (Immunogenicity) and Safety of NBP607-QIV (0.5 mL) (Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine) in Children Aged 6 to 35 Months

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.

开始日期2018-10-25

申办/合作机构

SK bioscience Co., Ltd.

NCT03020628 / Completed临床3期

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.

开始日期2016-10-01

申办/合作机构

SK Chemicals Co. Ltd.

NCT02806804 / Unknown status临床3期IIT

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.

开始日期2016-05-01

申办/合作机构-

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项与 Quadrivalent influenza virus vaccine(SK Chemicals Co. Ltd.) 相关的文献（医药）

2023-01-01·Vaccine

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

Article

作者: Moehling Geffel, Krissy ; Kim, Sara S ; Zimmerman, Richard K ; Susick, Michael ; Flannery, Brendan ; Levine, Min Z ; 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.

2022-08-01·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

作者: Rosen, Craig S ; Burn, Adam S ; Zeitzer, Jamie M ; Mathersul, Danielle C ; Wong, Melinda ; Hernandez, Beatriz ; Tang, Julia S ; Lazzeroni, Laura C ; Bayley, Peter J ; Avery, Tim ; 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.

2022-01-01·Multiple Sclerosis and Related Disorders3区 · 医学

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

3区 · 医学

Article

作者: 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.

项与 Quadrivalent influenza virus vaccine(SK Chemicals Co. Ltd.) 相关的新闻（医药）

2024-10-23

·PRNewswire

SK bioscience Announces Approval of Its Quadrivalent Influenza Vaccine in Indonesia

This approval paves the way for exports to the world's fourth most populous country. SK bioscience aims to continue to grow as a global vaccine brand beyond Korea by leveraging the advantages of cell-cultured vaccines. SEONGNAM, South Korea, Oct. 23, 2024 /PRNewswire/ -- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced that Indonesia's Food and Drug Agency, BPOM (Badan Pengawas Obat dan Makanan), has approved the Biologics License Application (BLA) for the SKYCellflu Quadrivalent prefilled syringe, the world's first quadrivalent cell-cultured influenza vaccine. This is the first time a domestically made influenza vaccine has received approval in Indonesia. Continue Reading SKYCellflu Quadrivalent prefilled syringe Indonesia is the world's fourth most populous nation with over 280 million people, with rapidly growing pharmaceutical market. According to global market research firm Innsight10, Indonesia's flu vaccine market is projected to grow from USD 38.5 million in 2022 to USD 69.1 million in 2030. Due to its elongated geography, spanning both Northern and Southern Hemispheres, Indonesia is impacted by the World Health Organization's flu vaccination guidelines for both regions. Following this approval of SKYCellflu for the Northern Hemisphere influenza strains, SK bioscience anticipates fast-tracked approval of flu vaccine for Southern Hemisphere influenza strains by the Indonesian Food and Drug Agency. SKYCellFlu is the world's first cell culture-based influenza vaccine to achieve WHO Prequalification (PQ) certification, demonstrating acceptable immunogenicity and safety across clinical trials. It is the only cell-cultured influenza vaccine currently available in Korea. Compared to the egg-based vaccines, its shorter production timeline makes it more suited for rapid response to pandemics or the emerging variants. SKYCellflu also does not require antibiotic or preservative administration. In addition, cell-cultured vaccines are less likely to mutate during the production process than those produced in fertilized eggs, allowing for a more accurate match to circulating influenza strains. In SK bioscience's research, the company conducted subcultures 15 times by employing cells for SKYCellflu production and fertilized eggs. Subculturing, also referred to as passaging cells, is the removal of the medium and transfer of cells from a previous culture into fresh growth medium, a procedure that enables the further propagation of the cell line or cell strain. The study results showed that mutations were found in three proteins within the virus in the fertilized egg method, while no mutations were found in the cells used for SKYCellflu production. These findings were presented at the 2019 Korea Interscience Working Group on Influenza (KIWI) Symposium. SKYCellflu has already been approved in multiple Asian countries, including Malaysia, Thailand, Myanmar, Iran, Singapore, Pakistan, Mongolia, and Brunei. Last year, it was granted in Chile, marking its first approval in the South American market. SK bioscience plans to pave the way for a full-scale expansion into global export markets. Jaeyong Ahn, CEO of SK bioscience, said, "It is very encouraging that our own developed vaccines are receiving approvals worldwide, a significant step for expanding our global export market." He added, "We are confident that SK bioscience will continue to grow into a global vaccine brand beyond Korea, as our vaccines, including shingles, chickenpox, and typhoid vaccines, are securing WHO PQ certifications and global approvals one after another." About SK bioscience SK bioscience is an innovative vaccine and biotech company, committed to vaccine development and manufacturing to enable more equitable access to vaccines around the world. Leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With the cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors, and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions. - SK bioscience Website - SK bioscience Linkedin Contact SK bioscience Communications Team Changhyun Jin([email protected]) Jeannie S. Pak([email protected]) SOURCE SK bioscience WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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适应症	国家/地区	公司	日期
流感病毒感染	韩国	SK Chemicals Co. Ltd.	2015-12-26

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适应症	最高研发状态	国家/地区	公司	日期
流感病毒感染	临床2期	-	SK Chemicals Co. Ltd.	2014-09-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02467842 (CTgov)	临床3期	流感病毒感染	1,503	NBP607-QIV (NBP607-QIV)	憲餘選網壓鏇衊廠窪蓋(製積壓構積鏇鏇鑰糧艱) = 鑰蓋艱願鑰網鏇艱獵鏇獵糧鏇製願窪繭獵構廠 (艱鑰鑰窪鑰觸願壓醖窪, 餘製膚壓窪鹹製鹹襯觸 ~ 製鬱顧襯簾淵觸夢網夢) 更多	-	2020-05-08
				NBP607-Y (NBP607-Y)	憲餘選網壓鏇衊廠窪蓋(製積壓構積鏇鏇鑰糧艱) = 鹹繭顧鹹遞範膚選餘鑰獵糧鏇製願窪繭獵構廠 (艱鑰鑰窪鑰觸願壓醖窪, 蓋繭鏇鬱範簾淵蓋窪糧 ~ 積鹽積獵積膚觸遞築遞) 更多
NCT02467842 (Pubmed)	临床3期	流感病毒感染	1,503	NBP607-QIV	艱憲齋鏇顧顧窪憲壓獵(顧繭壓獵膚顧顧蓋積繭) = 窪觸願簾製鬱鹽觸範獵獵築鏇夢餘夢願艱糧膚 (鑰衊遞獵觸繭鬱選積壓 ) 更多	-	2017-07-03
				NBP607-QIV (NBP607-Y)	艱憲齋鏇顧顧窪憲壓獵(顧繭壓獵膚顧顧蓋積繭) = 糧獵夢製製鹽繭壓窪憲獵築鏇夢餘夢願艱糧膚 (鑰衊遞獵觸繭鬱選積壓 ) 更多