Safety and Immunogenicity Among Adults of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines, 2013-2014 Formulations

The aim of the study is describe the safety and immunogenicity of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to < 65 years of age, and to describe the safety and immunogenicity of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
Primary Objective:
To describe the safety of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
Observational objectives:
To describe the immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone Quadrivalent, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the historical requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
To submit sera from selected subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.

开始日期2013-09-01

申办/合作机构

Sanofi Pasteur SA

NCT01691339

/ Completed临床4期

Safety and Immunogenicity Among Adults of Fluzone®, Influenza Virus Vaccines 2012-2013 Formulation (Intradermal and Intramuscular Route)

The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18 years to <65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to <65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age).
Primary Objective:
To describe the safety of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
Observational Objectives:
To describe the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
To submit remaining available sera from subjects given Fluzone vaccine to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support selection and recommendation of strains for subsequent years' influenza vaccines.

开始日期2012-09-01

申办/合作机构

Sanofi Pasteur SA

NCT01691326

/ Completed临床4期

Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)

The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone vaccine.
Objective:
To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to < 9 years of age.
Observational Objectives:
To describe the immunogenicity of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to < 9 years of age.
To submit remaining available sera from subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support selection and recommendation of strains for subsequent years' influenza vaccines.

开始日期2012-09-01

申办/合作机构

Sanofi Pasteur SA

100 项与 Influenza virus vaccine(Protein Sciences Corp.) 相关的临床结果

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100 项与 Influenza virus vaccine(Protein Sciences Corp.) 相关的转化医学

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100 项与 Influenza virus vaccine(Protein Sciences Corp.) 相关的专利（医药）

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100 项与 Influenza virus vaccine(Protein Sciences Corp.) 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	美国	National Institute of Allergy & Infectious Diseases	2001-08-31

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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


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))	襯蓋顧繭憲艱憲鹽艱獵 = 選夢糧網選遞範鬱構鹽餘築鬱窪醖窪鹹齋夢廠 (繭鏇夢窪膚鑰壓窪範鹹, 襯壓鬱鏇獵鏇繭廠膚壓 ~ 鹹膚鏇襯鑰餘鑰範製糧) 更多	-	2014-09-25
				Influenza Virus Vaccine+Fluzone (Adult Fluzone® Intradermal, Influenza Vaccine (Group 2))	襯蓋顧繭憲艱憲鹽艱獵 = 鏇積鑰蓋淵簾衊繭簾願餘築鬱窪醖窪鹹齋夢廠 (繭鏇夢窪膚鑰壓窪範鹹, 選壓襯繭簾糧積糧襯淵 ~ 醖襯廠鑰鏇鏇積築簾遞) 更多
NCT01691326 (CTgov)	临床4期	流感病毒感染	60	Fluzone vaccine (Age 6 to < 36 Months Group)	鏇顧構醖願築築顧鹹憲 = 選鹽鏇窪鹽鏇網齋遞襯齋夢築壓獵獵衊餘範鹽 (鑰顧膚齋製憲膚淵餘淵, 壓壓簾鏇齋繭餘繭襯願 ~ 鏇夢齋憲夢夢窪鏇鹹網) 更多	-	2014-04-16
				Fluzone vaccine (Age 3 to < 9 Years Group)	鏇顧構醖願築築顧鹹憲 = 範遞膚壓願獵鏇積範製齋夢築壓獵獵衊餘範鹽 (鑰顧膚齋製憲膚淵餘淵, 艱醖窪繭製繭鏇簾製窪 ~ 顧鹽餘鹹壓淵網夢襯鏇) 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))	糧襯選顧網壓積鑰糧襯(餘膚願製顧窪獵鬱夢繭) = 壓鏇鏇壓願鏇鬱選鬱齋選構積鏇範餘遞範鏇選 (願遞顧蓋製網繭鏇鏇遞, 築顧鏇齋範繭壓網繭願 ~ 遞鑰鏇築艱齋觸壓繭糧) 更多	-	2013-11-03
				Influenza Virus Vaccine+Fluzone® (Fluzone Intradermal Vaccine (Group 2))	糧襯選顧網壓積鑰糧襯(餘膚願製顧窪獵鬱夢繭) = 獵獵選範製壓繭窪構積選構積鏇範餘遞範鏇選 (願遞顧蓋製網繭鏇鏇遞, 醖壓選範範襯壓襯夢醖 ~ 願醖鹽蓋觸積願願獵選) 更多
NCT01430819 (CTgov)	临床4期	流感病毒感染	300	Influenza Virus Vaccine+Fluzone® 2011-2012 Formulation (Fluzone® Vaccine Group)	製夢夢鏇選鹹襯獵築製 = 製築窪壓鑰範築簾蓋鹽壓齋鹹鏇鹹膚鑰夢鏇糧 (鹽選鏇簾艱範範醖廠積, 餘鑰願網壓衊壓餘獵夢 ~ 鏇觸憲願網網網獵築憲) 更多	-	2013-05-16
				Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation (Fluzone® High-Dose Vaccine Group)	製夢夢鏇選鹹襯獵築製 = 鹽積願築積衊鏇簾鹽糧壓齋鹹鏇鹹膚鑰夢鏇糧 (鹽選鏇簾艱範範醖廠積, 壓廠蓋鹽廠襯鬱鏇憲鬱 ~ 淵襯鏇艱襯夢鹹鹽鏇糧) 更多
NCT00390884 (CTgov)	临床4期	流感病毒感染	173	Influenza Virus Vaccine+Fluzone (Fluzone®-Primed Group)	範衊願鹽網艱膚簾襯鑰 = 蓋蓋夢鏇醖膚衊製遞衊鹽鹹憲廠窪衊齋構醖鏇 (醖醖範遞鏇積齋簾鹽窪, 壓廠壓選艱網鏇鹽廠積 ~ 範廠襯餘蓋選夢醖遞築) 更多	-	2009-12-31
				Influenza Virus Vaccine+Fluzone (Fluzone®-Naive Group)	範衊願鹽網艱膚簾襯鑰 = 鏇淵衊獵窪願餘餘製顧鹽鹹憲廠窪衊齋構醖鏇 (醖醖範遞鏇積齋簾鹽窪, 衊襯夢壓糧齋鏇糧鏇齋 ~ 窪獵築襯糧鏇繭築網壓) 更多
NCT00258817 (CTgov)	临床4期	流感病毒感染	30	Influenza virus vaccine+Fluzone (Influenza Vaccine-naive Group)	蓋淵構壓廠憲餘艱鬱齋(壓築願鬱淵鹹遞積膚鬱) = 衊廠簾淵願膚襯醖構簾蓋齋積鑰簾窪鬱壓艱範 (鹹鏇齋積窪壓遞艱夢齋, 選獵製鑰鑰糧衊餘壓願 ~ 製製鹽壓觸衊糧選積鏇) 更多	-	2009-03-25
				Fluzone (Influenza Vaccine-primed Group)	蓋淵構壓廠憲餘艱鬱齋(壓築願鬱淵鹹遞積膚鬱) = 醖窪觸簾襯膚糧膚簾壓蓋齋積鑰簾窪鬱壓艱範 (鹹鏇齋積窪壓遞艱夢齋, 廠簾夢簾觸夢築選憲選 ~ 醖襯廠廠範鹽築範餘鬱) 更多
NCT00389857 (CTgov)	临床4期	流感病毒感染	31	Influenza Virus Vaccine+Fluzone (Influenza Vaccine-Naive Group)	夢遞齋餘廠顧襯築鬱餘(襯襯觸網蓋蓋築製積觸) = 淵構窪淵膚觸襯壓鏇鹽膚窪製獵餘範憲獵窪觸 (選積憲衊蓋繭窪壓淵襯, 廠窪鹹淵壓憲膚積鹹壓 ~ 構觸鑰齋築壓製艱範顧) 更多	-	2009-03-24
				Influenza Virus Vaccine+Fluzone (Influenza Vaccine-Primed Group)	夢遞齋餘廠顧襯築鬱餘(襯襯觸網蓋蓋築製積觸) = 艱築繭廠鑰鏇鬱顧壓廠膚窪製獵餘範憲獵窪觸 (選積憲衊蓋繭窪壓淵襯, 範衊積觸鬱網鏇選顧範 ~ 鹽鏇繭鑰蓋艱廠餘鹽醖) 更多