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

NCT02467842

/ Completed临床3期

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine in Adults and Elderly Subjects

All participants received a single dose of their assigned vaccine on Day 0. They were followed up for immunogenicity and safety through Day 21 post-vaccination. Serious adverse events were collected for 6 months post-vaccination.

开始日期2014-10-01

申办/合作机构

SK CHEMICALS CO LTD

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

2018-01-01·Vaccine3区 · 医学

Immunogenicity and safety of zoster vaccine live administered with quadrivalent influenza virus vaccine

3区 · 医学

Article

作者: Brown, Elizabeth ; Levin, Myron J ; Martin, Jason ; Gardner, Julie ; Popmihajlov, Zoran ; Buchwald, Ulrike K ; Stek, Jon E

OBJECTIVES:

Randomized, blinded, placebo-controlled trial to evaluate the safety and immunogenicity of ZOSTAVAX™ (ZV) administered concomitantly with quadrivalent inactivated influenza vaccine (IIV4) in adults≥50years of age (NCT02519855).

METHODS:

Overall, 440 participants were randomized into the Concomitant Group (CG) and 442 into the Sequential Group (SG). The CG received ZV and IIV4 at separate injection sites on Day 1 and matching placebo at Week 4. The SG received placebo and IIV4 (2015-2016 influenza season) at separate injection sites on Day 1 and ZV at Week 4.

IMMUNOGENICITY ENDPOINTS:

Varicella-zoster virus (VZV) antibody geometric mean titer (GMT) and geometric mean fold-rise (GMFR) from baseline to 4weeks postvaccination, measured by glycoprotein enzyme-linked immunosorbent assay (gpELISA) and adjusted for age and prevaccination titer. Influenza strain-specific GMT at baseline and 4weeks postvaccination was measured by hemagglutination inhibition (HAI) assay.

SAFETY ENDPOINTS:

Injection-site and systemic adverse experiences (AEs) within 28days following any vaccination and serious AEs throughout the study.

RESULTS:

The adjusted VZV antibody GMT ratio (CG/SG) was 0.87 (95%CI: 0.80, 0.95), meeting the prespecified noninferiority criterion. The VZV antibody GMFR in the CG was 1.9 (95%CI: 1.76, 2.05), meeting the acceptability criterion. Influenza antibody GMT ratios for A/H1N1, A/H3N2, B/Yamagata and B/Victoria were 1.02 (95%CI: 0.88, 1.18), 1.10 (95%CI: 0.94, 1.29), 1.00 (95%CI: 0.88, 1.14), and 0.99 (95%CI: 0.87, 1.13), respectively. The frequency of vaccine-related injection-site and systemic AEs was comparable between groups. No vaccine-related serious AE was observed.

CONCLUSION:

The concomitant administration of ZV and IIV4 to adults≥50years of age induced VZV-specific and influenza-specific antibody responses that were comparable to those following administration of either vaccine alone, and was generally well tolerated.

2017-07-03·Human Vaccines & Immunotherapeutics

Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects

Article

作者: Kim, Yeon-Sook ; Choi, Won Suk ; Song, Joon Young ; Woo, Heung Jeong ; Jung, Sook-In ; Kim, Kyung Ho ; Noh, Ji Yun ; Cheong, Hee Jin ; Wie, Seong-Heon ; Kim, Hun ; Kim, Woo Joo ; Kim, Shin-Woo ; Lee, Jin Soo ; Lee, Jacob ; Jeong, Hye Won

BACKGROUND:

The influenza B virus has two lineages; Yamagata and Victoria. The two lineages are antigenically distinct and it is difficult to expect cross-protection between the lineages. Actually, the mismatch between circulating influenza B viruses and vaccine strains has been occurred frequently. The cell-culture system for the production of influenza vaccine can contribute to improve vaccine strain selection and expand vaccine supplies. We investigated the immunogenicity and safety of cell culture-derived quadrivalent inactivated influenza vaccine (NBP607-QIV) in adults and elderly subjects.

METHODS:

A randomized controlled phase III trial was undertaken in 10 university hospitals in the Republic of Korea (Clinical trial Number-NCT02467842). Adults (aged 19-59 years) and elderly subjects (aged ≥60 years) were randomly assigned in a 2:1:1 ratio to NBP607-QIV versus cell culture-based trivalent inactivated influenza vaccine-Yamagata (NBP607-Y) and cell culture-based trivalent inactivated influenza vaccine-Victoria (NBP607-V). Immunogenicity was assessed 3 weeks after vaccination by hemagglutination inhibition assay. Safety was assessed for 6 months post-vaccination: solicited adverse events (AEs) for 7 days, unsolicited AEs for 21 days and serious adverse events (SAEs) for 6 months. AEs were sub-classified as adverse drug reactions (ADRs) according to the causality.

RESULTS:

A total of 1,503 participants were randomly assigned to NBP607-QIV (n = 752), NBP607-Y (n = 373) and NBP607-V (n = 378). The seroconversion rates of NBP607-QIV were 52.4%, 51.2%, 43.7% and 55.8% against A/H1N1, A/H3N2, B/Yamagata and B/Victoria, respectively. Non-inferiority against shared strains and superiority against alternate-lineage B strains were demonstrated for NBP607-QIV vs. NBP607-Y and NBP607-V. A total of 730 reactions occurred in 324 (43.1%) subjects of NBP607-QIV group. Majority of ADRs was solicited (99.2%) and mild (90.3%) in intensity. In adults (aged 19-59 years), solicited local AEs were slightly more frequent in NBP607-QIV group than NBP607-Y or NBP607-V group (40.9%, 33.4% and 32.5%, respectively). One SAE was observed among NBP607-QIV group, which was considered to be unrelated to the study vaccine within 3 weeks of vaccination and no vaccine-related SAEs were reported up to 6 months after vaccination.

CONCLUSIONS:

NBP607-QIV is a safe, well-tolerated and immunogenic influenza vaccine in Korean adults and elderly subjects.

1955-02-01·Canadian journal of microbiology4区 · 生物学

THE ANTIBODY RESPONSE IN MAN TO A QUADRIVALENT INFLUENZA VIRUS VACCINE

4区 · 生物学

Article

作者: Reid, D. B. W. ; Dempster, G. ; Buchner, Barbara K.

The antibody response to the subcutaneous inoculation of a single 1 ml. dose of a quadrivalent formalin-killed influenza virus egg vaccine has been measured. The vaccine used contained two A prime components and an A and a B component. Satisfactory responses were obtained two weeks after inoculation to the A and B components and to one of the A prime strains (FM1). A poor antibody response was noted to the other A prime strain incorporated in the vaccine (FW50). The highest levels were obtained with the Lee strain (Type B) which also stimulated an antibody rise to a recently isolated Type B strain. Antibody levels were maintained for at least 12 weeks. Treatment of the sera with RDE was found to influence the results obtained with the FM1 strain used.

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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流感病毒感染	印尼	SK bioscience Co., Ltd.	2024-10-23

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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)	餘築顧積願壓膚願鑰簾(膚衊築憲膚廠憲簾鏇蓋) = 淵簾構鏇積廠鹽築鬱構夢夢壓艱憲獵廠艱構範 (膚餘艱艱網選網蓋鏇襯, 艱範網襯鹹衊齋醖網衊 ~ 齋觸積積願繭鹹遞壓齋) 更多	-	2020-05-08
				NBP607-Y (NBP607-Y)	餘築顧積願壓膚願鑰簾(膚衊築憲膚廠憲簾鏇蓋) = 鏇鑰遞餘憲鏇糧範窪築夢夢壓艱憲獵廠艱構範 (膚餘艱艱網選網蓋鏇襯, 網艱餘蓋糧鹽範窪餘餘 ~ 淵壓衊鑰積鏇願顧願築) 更多
NCT02467842 (Pubmed \| Hum Vaccin Immunother)	临床3期	流感病毒感染	1,503	NBP607-QIV	膚餘範繭糧膚繭廠餘觸(積齋夢鑰衊築壓鹹遞壓) = 鹽齋積憲醖鏇醖範衊蓋積簾積糧糧糧製鹽淵製 (積鹹鏇夢鑰膚築糧衊糧 ) 更多	-	2017-07-03
				NBP607-QIV (NBP607-Y)	膚餘範繭糧膚繭廠餘觸(積齋夢鑰衊築壓鹹遞壓) = 鹽蓋構齋製選齋構繭簾積簾積糧糧糧製鹽淵製 (積鹹鏇夢鑰膚築糧衊糧 ) 更多