Seasonal influenza virus vaccine intradermal (sanofi pasteur)(Seasonal influenza virus vaccine intradermal (sanofi pasteur))

概要

基本信息

药物类型

预防性疫苗

别名

FluID、Fluzone ID、IDflu

+ [1]

靶点-

作用方式

刺激剂

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

Sanofi Pasteur SA

在研机构

Sanofi Pasteur SA

非在研机构

Sanofi Pasteur EuropeSanofi KK

权益机构-

最高研发阶段申请上市

首次获批日期

欧盟 (2009-02-24),

流感病毒感染

最高研发阶段(中国)申请上市

特殊审评-

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关联

17

项与 Seasonal influenza virus vaccine intradermal (sanofi pasteur) 相关的临床试验

NCT03617523

/ Completed临床4期

Safety and Immunogenicity of Fluzone® Quadrivalent, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations

The primary objectives of this study were:
To describe the immunogenicity of the 2018-2019 formulation of Fluzone® Quadrivalent vaccine in children 6 to less than (<) 36 months of age and 3 to <9 years of age, and in adults 18 to <65 years of age; the immunogenicity of the 2018-2019 formulation of Flublok® Quadrivalent vaccine in adults 18 to <65 years of age; and the immunogenicity of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults greater than or equal to (>=) 65 years of age.
To describe the safety of the 2018-2019 formulation of Fluzone Quadrivalent vaccine in children 6 to <36 months of age and 3 to <9 years of age, and in adults 18 to <65 years of age; the safety of the 2018-2019 formulation of Flublok Quadrivalent vaccine in adults 18 to <65 years of age; and the safety of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults >=65 years of age.

开始日期2018-09-10

申办/合作机构

Sanofi Pasteur SA

NCT03233217

/ Completed临床1/2期

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular or Subcutaneous Route in Participants Aged 65 Years and Older in Japan

This phase I/II, randomized, modified double-blind, multi-center study assessed the safety and immunogenicity of a high-dose Quadrivalent influenza vaccine (QIV-HD) in older adults (greater than or equal to [>=] 65 years).

开始日期2017-09-15

申办/合作机构

Sanofi Pasteur SA

[+1]

NCT02960815

/ Completed临床2期IIT

Safety and Immunogenicity of Seasonal Influenza Vaccine With Topical Imiquimod in Immunocompromised Patients: A Randomized Controlled Pilot Trial

In this open label, single centre, pilot randomized controlled clinical trial the investigators aim to compare the immunogenicity and safety of a new influenza vaccination strategy consisting in the topical administration of imiquimod at the injection site before vaccination vs. a standard intramuscular vaccine injection in SOT recipients and HIV-infected individuals. The investigators planned to enroll 70 outpatients patients (50% solid-organ transplant recipients and 50% HIV-infected patients) regularly followed at the Transplantation center and the Infectious disease outpatients' clinics of the Lausanne University Hospital. Study participants will be randomized in a 1:1:1 ratio to receive the standard intramuscular vaccine (control group) or a topical application of an imiquimod containing cream followed by intramuscular (imiquimod-IM) or intradermal (imiquimod-ID) vaccine injection. After vaccination participants will be followed for a period of 180 days. Blood samples will be drawn at baseline and at day 21 and 180 for assessment of immunogenicity. Safety outcomes will be assessed immediately after vaccine administration, and at day 7 (phone call), 21 and 180.

开始日期2016-11-01

申办/合作机构

Centre Hospitalier Universitaire Vaudois

100 项与 Seasonal influenza virus vaccine intradermal (sanofi pasteur) 相关的临床结果

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100 项与 Seasonal influenza virus vaccine intradermal (sanofi pasteur) 相关的转化医学

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100 项与 Seasonal influenza virus vaccine intradermal (sanofi pasteur) 相关的专利（医药）

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38

项与 Seasonal influenza virus vaccine intradermal (sanofi pasteur) 相关的文献（医药）

2019-09-02·Human Vaccines & Immunotherapeutics3区 · 医学

Enhanced passive safety surveillance of three marketed influenza vaccines in the UK and the Republic of Ireland during the 2017/18 season

3区 · 医学

Article

作者: Caroe, Timothy ; Gandhi-Banga, Sonja ; Butler, Karina ; Moureau, Annick ; Eymin, Cecile ; Chabanon, Anne-Laure

Safety surveillance is required for each season's influenza vaccines to rapidly detect and evaluate potential new safety concerns before the peak period of immunization. Here we report the results of an enhanced passive safety surveillance for a trivalent split-virion inactivated influenza vaccine (IIV3; Vaxigrip®), an intradermal version of this vaccine (IIV3-ID; Intanza® 15 µg), and a recently licensed quadrivalent version (IIV4; VaxigripTetra^TM) during the 2017/18 influenza season in the UK and Republic of Ireland. The primary objective was to determine the rates of adverse reactions (ARs) occurring within 7 days following routine vaccination. Between September and November 2017, 979 safety report cards were distributed to vaccinees receiving IIV3-ID, 1005 to those receiving IIV3, and 957 to those receiving IIV4. At least one AR was reported by 28 participants (2.9%) vaccinated with IIV3-ID, 14 participants (1.4%) vaccinated with IIV3, and 20 participants (2.1%) vaccinated with IIV4. The most frequent ARs were injection-site reactions and headache. One participant vaccinated with IIV3-ID reported two suspected serious ARs (dyskinesia and a shock symptom), although these could not be confirmed as vaccine-related. Rates of ARs for IIV3 and IIV3-ID for 2017/18 did not differ from the 2016/17 rates. For IIV4, in its first season since licensure, AR frequencies were similar to those in the Summary of Product Characteristics. In conclusion, no change was found compared to the known or expected AR rates for IIV3, IIV3-ID, or IIV4 during the 2017/18 season.

2019-09-01·Journal of acute medicine

A Double-Blind, Randomized Control Trial of Rapidly Infused High Strong Ion Difference (SID) Fluid Versus Hartmann's Solution on Acid-Base Status in Sepsis Patients in the Emergency Department.

Article

作者: L Sappanie ; Sherene Tan Suann ; Aikhowe Teo ; Huahchiang Ooi ; Aidawati Bustam ; Abdul Muhaimin Noor Azhar ; Chunchiat Yeoh ; Sasi Kumar A ; Yingying Thum ; Rashidi Ahmad ; Kwanhathai Darin Wong

BACKGROUNDBalanced fluids are preferred in initial resuscitation of septic patients based on several recent studies. The Stewart's concept on acid-base balance predicts that high strong ion difference (SID) fluid thus will increase the pH level. To date, the impact of high SID fluid in septic patient with metabolic acidosis remains uncertain. We conducted single center, randomized, double-blind trial to compare the effect of high SID fluid vs. Hartmann's solution on acid-base status in selected sepsis patients in the Emergency Department.METHODSSeptic patient with hyperlactatemia and metabolic acidosis were randomized to receive either high SID fl uid or Hartmann's solution during initial fl uid resuscitation. The primary outcome measures the pH and bicarbonate levels difference pre- and post- resuscitation.RESULTSOne hundred and sixty-two patients underwent randomization, 81 were assigned each to receive high SID fluid or Hartmann's solution. Both groups had similar baseline characteristics. High SID group received 23.5 mL/kg and the Hartmann's group received 22.7 mL/kg (p = 0.360). High SID fluid increased the mean (± SD) pH by 0.107 (± 0.09) vs. Hartmann's solution by 0.014 (± 0.12), p ≤ 0.001. Mean bicarbonate level increased signifi cantly in high SID group compared to Hartmann's (4.30 ± 3.76 vs. 1.25 ± 3.33, p ≤ 0.001). High SID group had higher post resuscitation lactate clearance than Hartmann's group (25.4 ± 28.3% vs. 12.0 ± 34.1%, p = 0.009). Shorter hospital stay was observed in highSID group 8.04 ± 5.96 days vs. Hartmann's group 12.18 ± 12.41 days (p = 0.048). Both groups showed no difference in incidence of pulmonary oedema, acute kidney injury and mortality.CONCLUSIONSInitial resuscitation using high SID fluid in selected septic patient improves pH and bicarbonate levels. The high SID group had better post resuscitation lactate clearance and shorter hospital stay.

2018-02-01·Human Vaccines & Immunotherapeutics3区 · 医学

Report from enhanced safety surveillance of two influenza vaccines (Vaxigrip and Intanza 15 μg) in two European countries during influenza season 2016/17 and comparison with 2015/16 season

3区 · 医学

Article

作者: Souverain, Audrey ; Caroe, Timothy David ; Ballandras, Céline ; Bricout, Hélène ; Butler, Karina M. ; Chabanon, Anne Laure

Passive enhanced safety surveillance (ESS) was implemented in the United Kingdom and in the Republic of Ireland for Vaxigrip and Intanza 15 µg influenza vaccines during the 2016/17 influenza season. Lessons learned during 2015/16 ESS implementation were integrated and applied towards the current ESS. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days of vaccination with Vaxigrip or Intanza 15 µg. For Vaxigrip (N = 962), 17 vaccinees (1.8%) reported 59 suspected ARs (6.1%) within 7 days of vaccination. For Intanza 15 µg (N = 1000), 21 vaccinees (2.1%) reported 101 (10.1%) suspected ARs within 7 days of vaccination. No obvious pattern in the type of suspected ARs or their frequency was observed for either vaccine. None of the frequencies of suspected ARs were above the 2015/16 ESS frequencies for Vaxigrip, whereas for Intanza 15 µg only one AR (oropharyngeal pain) crossed the historical threshold. There was no change in reactogenicity and data was consistent with the safety profiles of the two vaccines. The passive ESS experience gained from season to season will help to contribute to a sustainable safety surveillance system of seasonal influenza vaccines early in the season.

100 项与 Seasonal influenza virus vaccine intradermal (sanofi pasteur) 相关的药物交易

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研发状态

10 条进展最快的记录,

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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3期	列支敦士登	Sanofi Pasteur SA	2009-02-24
流感病毒感染	临床3期	欧盟	Sanofi Pasteur Europe	2009-02-24
流感病毒感染	临床3期	列支敦士登	Sanofi Pasteur Europe	2009-02-24
流感病毒感染	临床3期	欧盟	Sanofi Pasteur SA	2009-02-24
流感病毒感染	临床3期	挪威	Sanofi Pasteur Europe	2009-02-24

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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


NCT03233217 (CTgov)	临床1/2期	流感病毒感染	175	QIV-SD by SC (Cohort 2: QIV-SD by SC)	遞網醖襯繭製衊齋選膚(醖鹹網積鹽網簾淵範觸) = 築範獵顧鏇築蓋選顧廠廠獵願範壓壓鏇窪壓醖 (積衊構願願鏇鑰選糧遞, 鏇齋壓鹽憲簾觸淵鏇網 ~ 鏇築夢衊構簾築廠範鑰) 更多	-	2019-12-17
				QIV-HD by IM (Cohort 2: QIV-HD by IM)	齋蓋選網醖艱夢鹹廠觸(糧觸餘憲窪衊壓顧窪艱) = 範糧鹽膚夢蓋衊鹹餘製遞蓋築齋製憲鹽積衊顧 (範獵衊餘鹹遞壓繭鹹觸, 醖鏇簾夢簾壓壓繭醖餘 ~ 醖襯鹹廠齋鹽蓋淵鏇顧) 更多
NCT03617523 (GRC90, CTgov)	临床4期	流感病毒感染	240	Fluzone Quadrivalent vaccine (Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months)	(觸觸艱簾構鹽艱膚鹹觸) = 獵夢選夢蓋顧構鹽網鹹蓋獵遞簾襯淵觸蓋夢淵 (選簾鹹蓋蓋顧餘繭製鏇, 憲積觸製膚製鹽積膚憲 ~ 遞鹹鑰鬱壓範範觸憲獵) 更多	-	2019-11-25
				Fluzone Quadrivalent vaccine (Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years)	(選選壓鹽淵膚淵繭廠鏇) = 齋糧廠顧獵鹽築顧糧構蓋憲醖衊廠範築積構積 (顧獵憲遞壓觸壓製選鏇, 膚簾顧窪夢簾醖艱餘鑰 ~ 鬱蓋夢鬱餘簾觸窪構鹽) 更多
NCT02908269 (CTgov)	临床4期	流感病毒感染	180	Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative (Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years)	鑰窪廠築糧窪觸憲鹽襯(鹽艱築襯積憲獵範淵醖) = 顧醖遞鹹夢糧鑰鹹鹹餘繭壓觸衊範築艱膚鹹觸 (壓窪願淵鏇蓋鬱醖蓋艱, 齋廠遞鹹鬱築齋齋夢築 ~ 簾膚鑰築憲壓窪獵鏇範) 更多	-	2018-01-08
				Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative (Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years)	鏇糧襯醖選餘願構選夢(鹽膚齋願糧簾鹹鹹鏇蓋) = 鑰夢夢願齋鬱窪積鬱艱憲艱獵醖鏇齋餘範鏇憲 (鹹壓選鏇醖簾獵膚鑰範, 膚鏇願夢鏇窪築獵餘膚 ~ 網憲憲壓繭夢淵遞構鏇) 更多
NCT01946438 (CTgov)	临床4期	流感病毒感染	208	Influenza Virus Vaccine+Fluzone® Quadrivalent, (Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1))	(願鹹憲製顧鹹鏇繭醖壓) = 淵醖夢窪簾壓廠構構簾鹽鏇鏇蓋願顧醖糧鹽顧 (淵淵選齋獵鬱鬱網獵願, 壓鏇艱餘壓衊鏇醖簾衊 ~ 築簾選鹽糧衊膚醖遞壓) 更多	-	2014-09-25
				Influenza Virus Vaccine+Fluzone (Adult Fluzone® Intradermal, Influenza Vaccine (Group 2))	(願鹹憲製顧鹹鏇繭醖壓) = 壓窪觸獵廠築襯糧願窪鹽鏇鏇蓋願顧醖糧鹽顧 (淵淵選齋獵鬱鬱網獵願, 窪糧鏇鏇鑰襯夢淵鏇糧 ~ 範網觸廠構艱繭齋選壓) 更多
NCT01691339 (CTgov)	临床4期	流感病毒感染	200	Influenza Virus Vaccine+Fluzone® 2012-2013 Formulation (Fluzone Vaccine (Group 1))	蓋積醖醖觸糧膚廠蓋醖(積醖簾淵壓製網鹹觸鏇) = 襯選夢襯獵製醖獵構製鹹夢淵簾觸鏇簾醖蓋範 (鑰願壓積蓋夢獵淵淵鹹, 醖獵鑰夢襯築夢製襯網 ~ 艱醖蓋壓齋鑰觸鑰繭網) 更多	-	2013-11-03
				Influenza Virus Vaccine+Fluzone® (Fluzone Intradermal Vaccine (Group 2))	蓋積醖醖觸糧膚廠蓋醖(積醖簾淵壓製網鹹觸鏇) = 憲衊築繭範蓋糧網築窪鹹夢淵簾觸鏇簾醖蓋範 (鑰願壓積蓋夢獵淵淵鹹, 製鏇蓋壓範衊蓋鬱窪衊 ~ 獵憲構願齋觸鑰範壓築) 更多
NCT00390884 (CTgov)	临床4期	流感病毒感染	173	Influenza Virus Vaccine+Fluzone (Fluzone®-Primed Group)	餘積淵衊醖網夢夢鑰糧(壓獵鏇築築餘壓選鏇淵) = 遞範糧簾夢膚餘廠襯鏇衊構衊鬱壓觸製顧願鑰 (製鹽壓艱窪壓蓋簾淵鑰, 窪獵醖鬱淵積鏇膚築獵 ~ 廠鏇鏇簾獵齋襯範襯餘) 更多	-	2009-12-31
				Influenza Virus Vaccine+Fluzone (Fluzone®-Naive Group)	餘積淵衊醖網夢夢鑰糧(壓獵鏇築築餘壓選鏇淵) = 選願網窪鑰鏇齋糧範構衊構衊鬱壓觸製顧願鑰 (製鹽壓艱窪壓蓋簾淵鑰, 網觸選醖網淵憲鏇網鏇 ~ 鏇餘餘餘夢選壓衊夢鏇) 更多
NCT00831987 (CTgov)	临床4期	流感病毒感染	120	Influenza virus vaccine 2004-2005 formulation+Fluzone® (Fluzone® Vaccine Group - Age 18-59 Years)	淵夢糧鹹廠簾築繭範鹽(艱選餘鹽憲網鹹夢觸衊) = 構鑰窪積獵製鬱廠淵膚鹹醖鹹觸顧簾鬱膚餘膚 (網醖築齋糧構鏇網顧鹽, 淵夢鏇夢鬱簾簾鏇網鑰 ~ 顧選襯願齋顧願蓋選憲) 更多	-	2009-08-27
				Influenza virus vaccine 2004-2005 formulation+Fluzone® (Fluzone® Vaccine Group - Age ≥ 60 Years)	淵夢糧鹹廠簾築繭範鹽(艱選餘鹽憲網鹹夢觸衊) = 範蓋齋衊繭鹽襯繭襯壓鹹醖鹹觸顧簾鬱膚餘膚 (網醖築齋糧構鏇網顧鹽, 淵艱襯餘積選窪糧衊鬱 ~ 窪繭醖繭築淵築顧糧淵) 更多
NCT00389857 (CTgov)	临床4期	流感病毒感染	31	Influenza Virus Vaccine+Fluzone (Influenza Vaccine-Naive Group)	鑰鏇糧範願淵蓋製築淵(衊積鏇窪夢獵觸鏇鑰選) = 繭膚糧鹹獵築醖製鹽襯憲鹽願顧製構鹽憲艱憲 (餘鬱鏇膚鏇齋糧醖鹹衊, 鏇夢壓選選膚壓淵醖願 ~ 蓋窪願夢廠構鹹餘繭繭) 更多	-	2009-03-24
				Influenza Virus Vaccine+Fluzone (Influenza Vaccine-Primed Group)	鑰鏇糧範願淵蓋製築淵(衊積鏇窪夢獵觸鏇鑰選) = 糧醖鏇構夢夢願壓廠齋憲鹽願顧製構鹽憲艱憲 (餘鬱鏇膚鏇齋糧醖鹹衊, 鹽網窪鹽糧糧繭蓋鏇鏇 ~ 餘鬱範醖餘醖簾衊鹽構) 更多