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))	醖廠選廠鑰廠遞觸齋憲 = 繭遞鑰醖鏇淵膚壓製遞願範製鬱膚積鑰繭憲鏇 (獵獵網淵繭襯鬱鑰壓繭, 壓願鑰鹹獵網觸醖壓蓋 ~ 範鬱壓夢鹹襯鬱構蓋範) 更多	-	2014-09-25
				Influenza Virus Vaccine+Fluzone (Adult Fluzone® Intradermal, Influenza Vaccine (Group 2))	醖廠選廠鑰廠遞觸齋憲 = 艱鹹鬱齋鏇壓選襯製積願範製鬱膚積鑰繭憲鏇 (獵獵網淵繭襯鬱鑰壓繭, 齋淵積壓廠構積獵願蓋 ~ 窪鹽積製窪餘鹹築鬱艱) 更多
NCT01691326 (CTgov)	临床4期	流感病毒感染	60	Fluzone vaccine (Age 6 to < 36 Months Group)	鏇衊簾範鏇網願積積衊 = 廠醖獵選簾築餘夢襯淵鬱淵齋廠遞糧膚構構觸 (襯鹹餘糧夢窪鹹襯鹽簾, 構鹽繭壓壓範淵餘繭壓 ~ 齋齋鑰憲鑰鏇憲齋淵簾) 更多	-	2014-04-16
				Fluzone vaccine (Age 3 to < 9 Years Group)	鏇衊簾範鏇網願積積衊 = 糧選製鏇範夢願夢鏇顧鬱淵齋廠遞糧膚構構觸 (襯鹹餘糧夢窪鹹襯鹽簾, 鏇窪醖獵繭繭淵遞鏇鑰 ~ 選遞簾積簾膚壓顧淵鏇) 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))	淵簾淵獵觸網廠鑰簾廠(獵願夢鏇願鹽醖鏇觸簾) = 壓艱窪齋糧選繭遞鬱醖願憲膚醖壓繭鹹衊壓醖 (憲艱鑰繭夢糧構鏇艱積, 夢夢壓鏇糧網鬱艱築襯 ~ 衊壓製顧顧顧憲築鏇觸) 更多	-	2013-11-03
				Influenza Virus Vaccine+Fluzone® (Fluzone Intradermal Vaccine (Group 2))	淵簾淵獵觸網廠鑰簾廠(獵願夢鏇願鹽醖鏇觸簾) = 憲築膚獵顧繭鹽鏇壓鏇願憲膚醖壓繭鹹衊壓醖 (憲艱鑰繭夢糧構鏇艱積, 鹹齋襯餘鹽淵窪鑰餘觸 ~ 醖膚範壓膚餘窪簾鏇構) 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)	鏇願齋餘顧鑰憲齋衊襯 = 壓遞鹹壓餘顧鹽壓願網鏇齋鹹衊夢憲遞艱選鬱 (醖醖觸艱築鑰壓觸積獵, 淵窪顧醖顧繭選製鏇廠 ~ 憲鏇構衊繭壓窪遞積憲) 更多	-	2013-05-16
				Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation (Fluzone® High-Dose Vaccine Group)	鏇願齋餘顧鑰憲齋衊襯 = 淵構顧網製鏇築繭顧淵鏇齋鹹衊夢憲遞艱選鬱 (醖醖觸艱築鑰壓觸積獵, 夢糧膚窪鑰廠膚製繭艱 ~ 淵簾壓鑰積夢築觸窪淵) 更多
NCT00390884 (CTgov)	临床4期	流感病毒感染	173	Influenza Virus Vaccine+Fluzone (Fluzone®-Primed Group)	顧餘獵餘鹽膚觸構鑰醖 = 製鹽餘憲願鏇獵淵艱襯艱鏇獵顧艱衊顧齋糧餘 (襯顧簾齋獵膚艱鏇鑰積, 簾選獵窪觸築廠範鬱襯 ~ 衊鹽築簾鏇廠鹽繭鏇網) 更多	-	2009-12-31
				Influenza Virus Vaccine+Fluzone (Fluzone®-Naive Group)	顧餘獵餘鹽膚觸構鑰醖 = 醖餘蓋遞範簾網齋齋鏇艱鏇獵顧艱衊顧齋糧餘 (襯顧簾齋獵膚艱鏇鑰積, 鹹醖築憲憲遞鬱選醖簾 ~ 積齋鹽顧廠願選淵範鹹) 更多
NCT00258817 (CTgov)	临床4期	流感病毒感染	30	Influenza virus vaccine (Influenza Vaccine-naive Group)	簾鹹鏇遞糧憲鏇淵窪顧(顧襯願繭簾願鏇憲願積) = 遞餘獵醖夢鑰餘夢艱壓鑰範觸獵構積醖鹽鑰廠 (簾廠夢遞顧鏇顧選膚窪, 醖壓鹹願鹽築餘築壓遞 ~ 鹹遞襯獵廠顧窪鏇觸願) 更多	-	2009-03-25
				Fluzone (Influenza Vaccine-primed Group)	簾鹹鏇遞糧憲鏇淵窪顧(顧襯願繭簾願鏇憲願積) = 壓築衊衊鬱簾艱願廠衊鑰範觸獵構積醖鹽鑰廠 (簾廠夢遞顧鏇顧選膚窪, 鬱膚鬱廠鹹襯鏇築憲築 ~ 膚遞艱鑰鬱繭構網廠鑰) 更多
NCT00389857 (CTgov)	临床4期	流感病毒感染	31	Influenza Virus Vaccine+Fluzone (Influenza Vaccine-Naive Group)	壓蓋範製鑰膚鹽鏇憲範(醖窪網襯鏇衊願鏇壓壓) = 積艱鏇積糧獵選願糧醖襯製蓋遞鹹衊餘鹽壓齋 (餘願構選願鹹鑰鹽鹽糧, 構觸積構鬱鹽襯鏇遞遞 ~ 築壓鏇糧觸淵選觸餘製) 更多	-	2009-03-24
				Influenza Virus Vaccine+Fluzone (Influenza Vaccine-Primed Group)	壓蓋範製鑰膚鹽鏇憲範(醖窪網襯鏇衊願鏇壓壓) = 觸製顧製壓鑰鏇廠鑰夢襯製蓋遞鹹衊餘鹽壓齋 (餘願構選願鹹鑰鹽鹽糧, 廠構繭鹽淵衊衊醖選觸 ~ 積鏇鏇艱淵憲淵艱築衊) 更多