Trivalent Seasonal Influenza Vaccine(Instituto Butantan)(Trivalent Seasonal Influenza Vaccine(Instituto Butantan))

概要

基本信息

药物类型

预防性疫苗、多价疫苗

别名-

靶点-

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病

在研适应症

流感病毒感染

非在研适应症-

原研机构

Instituto Butantan

在研机构

Instituto Butantan

非在研机构-

最高研发阶段批准上市

首次获批日期

巴西 (2013-01-01),

流感病毒感染

最高研发阶段(中国)-

特殊审评-

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关联

1

项与 Trivalent Seasonal Influenza Vaccine(Instituto Butantan) 相关的临床试验

NCT02640989 / Completed临床4期IIT

Safety and Immunogenicity of Three Seasonal Trivalent Influenza Vaccines in China Military

The purpose of this study is to assess the safety and immunogenicity of three seasonal trivalent influenza vaccines (TIVs)manufactured by Glaxosmith Kline (GSK), Beijing Sinovac Biotech (Sinovac) and Shenzhen Sanofi Pasteur (Pasteur) in Chinese healthy servicemen. Using imported GSK's TIV as control, to compare it with other two domestic TIVs in Chinese healthy servicemen.

开始日期2014-10-01

申办/合作机构-

100 项与 Trivalent Seasonal Influenza Vaccine(Instituto Butantan) 相关的临床结果

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100 项与 Trivalent Seasonal Influenza Vaccine(Instituto Butantan) 相关的转化医学

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100 项与 Trivalent Seasonal Influenza Vaccine(Instituto Butantan) 相关的专利（医药）

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66

项与 Trivalent Seasonal Influenza Vaccine(Instituto Butantan) 相关的文献（医药）

2023-12-31·Expert review of vaccines

Immunogenicity and safety of seasonal influenza vaccines in children under 3 years of age

Review

作者: Aoun, Tia ; Arkwright, Peter D. ; Borrow, Ray

INTRODUCTION:

Despite children aged 6-35 months developing more severe influenza infections, not all countries include influenza vaccines in their national immunization programs.

AREAS COVERED:

This literature review examines the efficacy, immunogenicity, and safety of seasonal trivalent influenza vaccines (TIVs) and quadrivalent influenzae vaccines (QIVs) in children 6-35 months old to determine if greater valency promotes greater protection while maintaining a similar safety profile.

EXPERT OPINION:

TIVs and QIVs are safe for children under 3 years old. TIVs and QIVs provided good seroprotection, and immunogenicity (GMT, SCR, and SPR) meeting recommended levels set by CHMP (European) and CBER (USA). However, as QIVs carry two influenza B strains and TIVs only one, QIVs has an overall higher seroprotection against particularly influenza B. Vaccines containing adjuncts had better immunogenicity, particularly after the first dose. Seroprotection of all vaccines lasted 12 months. Increasing the dosage from 0.25 mL to 0.5 mL did not cause more systemic or local side-effects. Further comparisons of efficacy, and wider promotion of influenza vaccines in general are required in preschool children.

2023-05-22·Vaccine

A randomized, double-blind, non-inferiority trial comparing the immunogenicity and safety of two seasonal inactivated influenza vaccines in adults.

Article

作者: de Oliveira, Mayra Martho Moura ; Weckx, Lily Yin ; Timenetsky, Maria do Carmo S. T. ; Viscondi, Juliana Yukari Kodaira ; Coelho, Eduardo B. ; Precioso, Alexander Roberto ; Vanni, Tazio ; Koike, Marcelo Eiji ; Gattas, Vera Lucia ; Braga, Patricia Emilia ; Lara, Amanda Nazareth ; da Silva, Anderson ; de Oliveira Piorelli, Roberta ; Campos, Lucia M. A. ; Lucchesi, Maria Beatriz Bastos ; Paiva, Terezinha M. ; do Prado Santos, Joane ; da Graca Salomao, Maria

BACKGROUND:

To enhance the production and availability of influenza vaccines in different regions of the world is paramount to mitigate the global burden of this disease. Instituto Butantan developed and manufactured an embryonated egg-based inactivated split-virion trivalent seasonal influenza vaccine as part of a technology transfer partnership with Sanofi Pasteur.

METHODS:

This is a phase IV, randomized, double-blind, active-controlled, multicenter clinical trial including adults 18-60 and > 60 years recruited during the 2019 southern hemisphere influenza season. Subjects were randomized 1:1 to receive either the Sanofi Pasteur Trivalent Seasonal Influenza Vaccine (SP-TIV) or Instituto Butantan Trivalent Seasonal Influenza Vaccine (IB-TIV). Hemagglutinin inhibition antibody titers were assessed pre-vaccination and 21 days post-vaccination.

RESULTS:

624 participants were randomized and vaccinated. In both intention-to-treat and per-protocol analysis, non-inferiority of the SP-TIV versus IB-TIV was demonstrated for the three influenza strains. In the per-protocol analysis, the SP-GMT/IB-GMT ratios for H1N1, H3N2, and B were 0.9 (95%CI, 0.7-1.1), 1.2 (95%CI, 1.0-1.4), and 1.1 (95%CI, 0.9-1.3), respectively. Across vaccination groups, the most common adverse reactions (AR) were limited to the injection-site, including pain and tenderness. The majority of the ARs were graded 1 and/or 2 and lasted less than one day. No serious adverse reaction was observed.

CONCLUSION:

This study demonstrated the non-inferiority of the immunogenicity of a single-dose of Instituto Butantan versus a single dose of the Sanofi Pasteur Seasonal Trivalent Influenza Vaccine in adults. Both vaccines were well tolerated and presented similar safety profiles.

2022-10-01·Respirology (Carlton, Vic.)

Effectiveness of influenza and pneumococcal vaccines on chronic obstructive pulmonary disease exacerbations

Article

作者: Wang, Yamin ; Yin, Zundong ; Yue, Chenyan ; Li, Yan ; Liu, Yunqiu ; Wang, Liye ; Li, Keli ; Ma, Ying ; An, Zhijie ; Yuan, Xiaodong ; Wang, Huaqing ; Zhang, Pingshu

Abstract:

Background and objective:

Single‐study evidence of separate and combined effectiveness of influenza and pneumococcal vaccination in patients with chronic obstructive pulmonary disease (COPD) is limited. To fill this gap, we studied the effectiveness of trivalent seasonal influenza vaccine (TIV) and 23‐valent pneumococcal polysaccharide vaccine (PPSV23), separately and together, at preventing adverse COPD outcomes.

Methods:

Our study used a self‐controlled, before‐and‐after cohort design to assess the effectiveness of TIV and PPSV23 in COPD patients. Patients were recruited from hospitals in Tangshan City, Hebei Province, China. Subjects self‐selected into one of the three vaccination schedules: TIV group, PPSV23 group and TIV&PPSV23 group. We used a physician‐completed, medical record‐verified questionnaire to obtain data on acute exacerbations of COPD (AECOPD), pneumonia and related hospitalization. Vaccine effectiveness was determined by comparing COPD outcomes before and after vaccination, controlling for potential confounding using Cox regression.

Results:

We recruited 474 COPD patients, of whom 109 received TIV, 69 received PPSV23 and 296 received TIV and PPSV23. Overall effectiveness for preventing AECOPD, pneumonia and related hospitalization were respectively 70%, 59% and 58% in the TIV group; 54%, 53% and 46% in the PPSV23 group; and 72%, 73% and 69% in the TIV&PPSV23 group. The vaccine effectiveness without COVID‐19 non‐pharmaceutical intervention period were 84%, 77% and 88% in the TIV group; 63%, 74% and 66% in the PPSV23 group; and 82%, 83% and 91% in the TIV&PPSV23 group.

Conclusion:

Influenza vaccination and PPSV23 vaccination, separately and together, can effectively reduce the risk of AECOPD, pneumonia and related hospitalization. Effectiveness for preventing AECOPD was the greatest.

100 项与 Trivalent Seasonal Influenza Vaccine(Instituto Butantan) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07BB01	-

研发状态

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适应症	国家/地区	公司	日期
流感病毒感染	巴西	Instituto Butantan	2013-01-01

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临床结果

适应症

分期

评价

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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


Pubmed \| Vaccine	N/A	-	313	AS03-adjuvanted A(H1N1)pmd09 vaccine sequentially administered	餘餘鏇鬱鏇衊衊蓋蓋觸(窪醖鏇鏇築鏇夢齋壓餘) = 願壓簾獵餘鏇願醖積廠簾廠膚夢顧壓遞繭糧夢 (築膚構鹽窪淵網遞積繭, 76 ~ 94)	-	2012-10-05
				AS03-adjuvanted A(H1N1)pmd09 vaccine co-administered	餘餘鏇鬱鏇衊衊蓋蓋觸(窪醖鏇鏇築鏇夢齋壓餘) = 遞艱襯壓範壓窪膚襯窪簾廠膚夢顧壓遞繭糧夢 (築膚構鹽窪淵網遞積繭, 90 ~ 99)