このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older

2018年5月8日 更新者：GlaxoSmithKline

Observer-blind Superior Efficacy Trial With GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects

The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This Protocol Posting has been updated according to Protocol Amendment 3, Sep 2009.

After the analyses for this study were completed, questions arose regarding the integrity of study data from a single study site in Romania, which enrolled 102 subjects in the trial. Because evaluation of data from this site did not reveal irregularities when compared with overall study data and because GSK has no current plans to use the data from the study in support of any regulatory filings, they were not excluded from the analyses reflected in this results summary.

研究の種類

介入

入学 (実際)

43695

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Alabama
      • Alabaster、Alabama、アメリカ、35007
        • GSK Investigational Site
      • Huntsville、Alabama、アメリカ、35802
        • GSK Investigational Site
      • Mobile、Alabama、アメリカ、36608
        • GSK Investigational Site
    • Arizona
      • Chandler、Arizona、アメリカ、85224
        • GSK Investigational Site
      • Mesa、Arizona、アメリカ、85213
        • GSK Investigational Site
      • Mesa、Arizona、アメリカ、85203
        • GSK Investigational Site
      • Phoenix、Arizona、アメリカ、85020
        • GSK Investigational Site
      • Phoenix、Arizona、アメリカ、85050
        • GSK Investigational Site
      • Phoenix、Arizona、アメリカ、85028
        • GSK Investigational Site
      • Tempe、Arizona、アメリカ、85283
        • GSK Investigational Site
    • Arkansas
      • Hot Springs、Arkansas、アメリカ、71901
        • GSK Investigational Site
      • Little Rock、Arkansas、アメリカ、72205
        • GSK Investigational Site
    • California
      • Anaheim、California、アメリカ、92801
        • GSK Investigational Site
      • Santa Ana、California、アメリカ、92705
        • GSK Investigational Site
    • Florida
      • Clearwater、Florida、アメリカ、33761
        • GSK Investigational Site
      • Coral Gables、Florida、アメリカ、33134
        • GSK Investigational Site
      • Crystal River、Florida、アメリカ、34429
        • GSK Investigational Site
      • Delray Beach、Florida、アメリカ、33484
        • GSK Investigational Site
      • Inverness、Florida、アメリカ、34452
        • GSK Investigational Site
      • Jacksonville、Florida、アメリカ、32216
        • GSK Investigational Site
      • Jacksonville、Florida、アメリカ、32205
        • GSK Investigational Site
      • Pembroke Pines、Florida、アメリカ、33024
        • GSK Investigational Site
    • Idaho
      • Boise、Idaho、アメリカ、83642
        • GSK Investigational Site
    • Illinois
      • Peoria、Illinois、アメリカ、61602
        • GSK Investigational Site
    • Kansas
      • Overland Park、Kansas、アメリカ、66212
        • GSK Investigational Site
      • Wichita、Kansas、アメリカ、67207
        • GSK Investigational Site
    • Missouri
      • Kansas City、Missouri、アメリカ、64114
        • GSK Investigational Site
      • Saint Louis、Missouri、アメリカ、63141
        • GSK Investigational Site
      • Saint Louis、Missouri、アメリカ、63104
        • GSK Investigational Site
    • Nebraska
      • Omaha、Nebraska、アメリカ、68134
        • GSK Investigational Site
    • Nevada
      • Las Vegas、Nevada、アメリカ、89104
        • GSK Investigational Site
    • New Jersey
      • Hackensack、New Jersey、アメリカ、07601
        • GSK Investigational Site
      • Somers Point、New Jersey、アメリカ、08244
        • GSK Investigational Site
    • New York
      • Camillus、New York、アメリカ、13031
        • GSK Investigational Site
      • Endwell、New York、アメリカ、13760
        • GSK Investigational Site
      • Johnson City、New York、アメリカ、13790
        • GSK Investigational Site
      • Rochester、New York、アメリカ、14621
        • GSK Investigational Site
    • North Carolina
      • Cary、North Carolina、アメリカ、27518
        • GSK Investigational Site
      • Charlotte、North Carolina、アメリカ、28209
        • GSK Investigational Site
      • Hickory、North Carolina、アメリカ、28601
        • GSK Investigational Site
      • Raleigh、North Carolina、アメリカ、27612
        • GSK Investigational Site
      • Raleigh、North Carolina、アメリカ、27609
        • GSK Investigational Site
      • Salisbury、North Carolina、アメリカ、28144
        • GSK Investigational Site
      • Tabor City、North Carolina、アメリカ、28463
        • GSK Investigational Site
    • Pennsylvania
      • Carnegie、Pennsylvania、アメリカ、15106
        • GSK Investigational Site
      • Erie、Pennsylvania、アメリカ、16506
        • GSK Investigational Site
      • Grove City、Pennsylvania、アメリカ、16127
        • GSK Investigational Site
      • Jefferson Hills、Pennsylvania、アメリカ、15025
        • GSK Investigational Site
      • Philadelphia、Pennsylvania、アメリカ、19102
        • GSK Investigational Site
      • Pittsburgh、Pennsylvania、アメリカ、15236
        • GSK Investigational Site
      • Pittsburgh、Pennsylvania、アメリカ、15241
        • GSK Investigational Site
      • Pittsburgh、Pennsylvania、アメリカ、15205
        • GSK Investigational Site
      • Uniontown、Pennsylvania、アメリカ、15401
        • GSK Investigational Site
      • Upper Saint Clair、Pennsylvania、アメリカ、15241
        • GSK Investigational Site
    • Rhode Island
      • Warwick、Rhode Island、アメリカ、02886
        • GSK Investigational Site
    • South Carolina
      • Charleston、South Carolina、アメリカ、29412
        • GSK Investigational Site
      • North Myrtle Beach、South Carolina、アメリカ、29582
        • GSK Investigational Site
      • Spartanburg、South Carolina、アメリカ、29303
        • GSK Investigational Site
    • Texas
      • Houston、Texas、アメリカ、77030
        • GSK Investigational Site
    • Utah
      • Salt Lake City、Utah、アメリカ、84109
        • GSK Investigational Site
      • Salt Lake City、Utah、アメリカ、84121
        • GSK Investigational Site
      • West Jordan、Utah、アメリカ、84088
        • GSK Investigational Site
    • Wisconsin
      • Marshfield、Wisconsin、アメリカ、54449
        • GSK Investigational Site
  • イギリス
      • Waterloo, Liverpool、イギリス、L22 0LG
        • GSK Investigational Site
    • Berkshire
      • Reading、Berkshire、イギリス、RG2 0TG
        • GSK Investigational Site
    • Lancashire
      • Buckshaw Village, Chorley、Lancashire、イギリス、PR7 7NA
        • GSK Investigational Site
    • Merseyside
      • Liverpool、Merseyside、イギリス、L22 0LG
        • GSK Investigational Site
  • エストニア
      • Saku、エストニア、75501
        • GSK Investigational Site
      • Tallinn、エストニア、10117
        • GSK Investigational Site
      • Tallinn、エストニア、13419
        • GSK Investigational Site
      • Tallinn、エストニア、10617
        • GSK Investigational Site
      • Tallinn、エストニア、13619
        • GSK Investigational Site
      • Tartu、エストニア、50106
        • GSK Investigational Site
      • Tartu、エストニア、50410
        • GSK Investigational Site
  • オランダ
      • Rotterdam、オランダ、3001 DC
        • GSK Investigational Site
      • Rotterdam、オランダ、3011 EN
        • GSK Investigational Site
      • Soest、オランダ、3762 BN
        • GSK Investigational Site
      • Utrecht、オランダ、3584 CX
        • GSK Investigational Site
  • カナダ
      • Quebec、カナダ、G1W 4R4
        • GSK Investigational Site
    • British Columbia
      • Coquitlam、British Columbia、カナダ、V3K 3P4
        • GSK Investigational Site
      • Vancouver、British Columbia、カナダ、V5Z 1M9
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Bay Roberts、Newfoundland and Labrador、カナダ、A0A 1G0
        • GSK Investigational Site
    • Nova Scotia
      • Halifax、Nova Scotia、カナダ、B3K 6R8
        • GSK Investigational Site
      • Truro、Nova Scotia、カナダ、B2N 1L2
        • GSK Investigational Site
    • Ontario
      • Brampton、Ontario、カナダ、L6T 3T1
        • GSK Investigational Site
      • Sudbury、Ontario、カナダ、P3E 1H5
        • GSK Investigational Site
      • Toronto、Ontario、カナダ、M9W 4L6
        • GSK Investigational Site
    • Quebec
      • Gatineau、Quebec、カナダ、J8Y 6S8
        • GSK Investigational Site
      • Sherbrooke、Quebec、カナダ、J1H 4J6
        • GSK Investigational Site
      • St-Romulad、Quebec、カナダ、G6W 5M6
        • GSK Investigational Site
  • チェコ
      • Hradec Kralove、チェコ、500 03
        • GSK Investigational Site
      • Jaroměř、チェコ、551 02
        • GSK Investigational Site
      • Jaroměř、チェコ
        • GSK Investigational Site
      • Pardubice、チェコ、530 02
        • GSK Investigational Site
      • Pardubice、チェコ、530 12
        • GSK Investigational Site
      • Pardubice、チェコ
        • GSK Investigational Site
  • ドイツ
      • Berlin、ドイツ、10367
        • GSK Investigational Site
      • Berlin、ドイツ、13086
        • GSK Investigational Site
      • Berlin、ドイツ、10717
        • GSK Investigational Site
      • Berlin、ドイツ、10777
        • GSK Investigational Site
      • Berlin、ドイツ、13125
        • GSK Investigational Site
      • Berlin、ドイツ、10629
        • GSK Investigational Site
      • Berlin、ドイツ、10787
        • GSK Investigational Site
      • Berlin、ドイツ、13347
        • GSK Investigational Site
      • Berlin、ドイツ、12627
        • GSK Investigational Site
      • Berlin、ドイツ、10435
        • GSK Investigational Site
      • Berlin、ドイツ、10365
        • GSK Investigational Site
      • Berlin、ドイツ、12157
        • GSK Investigational Site
      • Hamburg、ドイツ、22143
        • GSK Investigational Site
      • Hamburg、ドイツ、20246
        • GSK Investigational Site
      • Hamburg、ドイツ、20253
        • GSK Investigational Site
      • Hamburg、ドイツ、22415
        • GSK Investigational Site
      • Hamburg、ドイツ、22335
        • GSK Investigational Site
      • Hamburg、ドイツ、22769
        • GSK Investigational Site
      • Hamburg、ドイツ、22339
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Gueglingen、Baden-Wuerttemberg、ドイツ、74363
        • GSK Investigational Site
      • Mannheim、Baden-Wuerttemberg、ドイツ、68161
        • GSK Investigational Site
      • Messkirch、Baden-Wuerttemberg、ドイツ、88605
        • GSK Investigational Site
      • Rudersberg、Baden-Wuerttemberg、ドイツ、73635
        • GSK Investigational Site
      • Schwetzingen、Baden-Wuerttemberg、ドイツ、68723
        • GSK Investigational Site
      • Sinsheim、Baden-Wuerttemberg、ドイツ、74889
        • GSK Investigational Site
      • Tuebingen、Baden-Wuerttemberg、ドイツ、72074
        • GSK Investigational Site
      • Weinheim、Baden-Wuerttemberg、ドイツ、69469
        • GSK Investigational Site
    • Bayern
      • Augsburg、Bayern、ドイツ、86150
        • GSK Investigational Site
      • Haag、Bayern、ドイツ、83527
        • GSK Investigational Site
      • Hoehenkirchen-Siegertsbrunn、Bayern、ドイツ、85635
        • GSK Investigational Site
      • Kuenzing、Bayern、ドイツ、94550
        • GSK Investigational Site
      • Muenchen、Bayern、ドイツ、80339
        • GSK Investigational Site
      • Muenchen、Bayern、ドイツ、80636
        • GSK Investigational Site
      • Rednitzhembach、Bayern、ドイツ、91126
        • GSK Investigational Site
      • Wuerzburg、Bayern、ドイツ、97070
        • GSK Investigational Site
    • Brandenburg
      • Cottbus、Brandenburg、ドイツ、03050
        • GSK Investigational Site
      • Ketzin、Brandenburg、ドイツ、14669
        • GSK Investigational Site
      • Ruedersdorf、Brandenburg、ドイツ、15562
        • GSK Investigational Site
    • Hessen
      • Bad Kreuznach、Hessen、ドイツ、55545
        • GSK Investigational Site
      • Floersheim、Hessen、ドイツ、65439
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Rostock、Mecklenburg-Vorpommern、ドイツ、18057
        • GSK Investigational Site
      • Schwerin、Mecklenburg-Vorpommern、ドイツ、19055
        • GSK Investigational Site
    • Niedersachsen
      • Brinkum/Stuhr、Niedersachsen、ドイツ、28816
        • GSK Investigational Site
      • Duelmen、Niedersachsen、ドイツ、48249
        • GSK Investigational Site
      • Koenigslutter、Niedersachsen、ドイツ、38154
        • GSK Investigational Site
      • Rotenburg (Wuemme)、Niedersachsen、ドイツ、27356
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bochum、Nordrhein-Westfalen、ドイツ、44787
        • GSK Investigational Site
      • Essen、Nordrhein-Westfalen、ドイツ、45359
        • GSK Investigational Site
      • Goch、Nordrhein-Westfalen、ドイツ、47574
        • GSK Investigational Site
      • Koeln、Nordrhein-Westfalen、ドイツ、51069
        • GSK Investigational Site
      • Koeln、Nordrhein-Westfalen、ドイツ、51063
        • GSK Investigational Site
      • Muenster、Nordrhein-Westfalen、ドイツ、48155
        • GSK Investigational Site
      • Witten、Nordrhein-Westfalen、ドイツ、58455
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Ingelheim、Rheinland-Pfalz、ドイツ、55218
        • GSK Investigational Site
      • Kallstadt、Rheinland-Pfalz、ドイツ、67169
        • GSK Investigational Site
      • Mainz、Rheinland-Pfalz、ドイツ、55116
        • GSK Investigational Site
      • Mainz、Rheinland-Pfalz、ドイツ、55131
        • GSK Investigational Site
      • Rhaunen、Rheinland-Pfalz、ドイツ、55624
        • GSK Investigational Site
    • Sachsen
      • Borna、Sachsen、ドイツ、04552
        • GSK Investigational Site
      • Delitzsch、Sachsen、ドイツ、04509
        • GSK Investigational Site
      • Dresden、Sachsen、ドイツ、01307
        • GSK Investigational Site
      • Dresden、Sachsen、ドイツ、01069
        • GSK Investigational Site
      • Dresden、Sachsen、ドイツ、01099
        • GSK Investigational Site
      • Freiberg、Sachsen、ドイツ、09599
        • GSK Investigational Site
      • Freital、Sachsen、ドイツ、01705
        • GSK Investigational Site
      • Geringswalde、Sachsen、ドイツ、09326
        • GSK Investigational Site
      • Leipzig、Sachsen、ドイツ、04315
        • GSK Investigational Site
      • Leipzig、Sachsen、ドイツ、04103
        • GSK Investigational Site
      • Leipzig、Sachsen、ドイツ、04207
        • GSK Investigational Site
      • Schmiedeberg、Sachsen、ドイツ、01762
        • GSK Investigational Site
      • Weissenberg、Sachsen、ドイツ、02627
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Koethen、Sachsen-Anhalt、ドイツ、06366
        • GSK Investigational Site
      • Magdeburg、Sachsen-Anhalt、ドイツ、39112
        • GSK Investigational Site
      • Magdeburg、Sachsen-Anhalt、ドイツ、39104
        • GSK Investigational Site
      • Wolmirstedt、Sachsen-Anhalt、ドイツ、39326
        • GSK Investigational Site
    • Schleswig-Holstein
      • Bad Bramstedt、Schleswig-Holstein、ドイツ、24576
        • GSK Investigational Site
      • Bad Segeberg、Schleswig-Holstein、ドイツ、23795
        • GSK Investigational Site
      • Luebeck、Schleswig-Holstein、ドイツ、23554
        • GSK Investigational Site
    • Thueringen
      • Erfurt、Thueringen、ドイツ、99084
        • GSK Investigational Site
  • ノルウェー
      • Alesund、ノルウェー
        • GSK Investigational Site
      • Bekkestua、ノルウェー、1319
        • GSK Investigational Site
      • Bergen、ノルウェー、5094
        • GSK Investigational Site
      • Elverum、ノルウェー、2408
        • GSK Investigational Site
      • Hamar、ノルウェー、2317
        • GSK Investigational Site
      • Oslo、ノルウェー、0277
        • GSK Investigational Site
      • Oslo、ノルウェー、0484
        • GSK Investigational Site
      • Skien、ノルウェー、3717
        • GSK Investigational Site
      • Stavanger、ノルウェー、4005
        • GSK Investigational Site
  • フランス
      • Angers、フランス、49100
        • GSK Investigational Site
      • Angers、フランス、49000
        • GSK Investigational Site
      • Anzin、フランス、59410
        • GSK Investigational Site
      • Arras、フランス、62000
        • GSK Investigational Site
      • Bordeaux、フランス、33200
        • GSK Investigational Site
      • Bécon les Granits、フランス、49370
        • GSK Investigational Site
      • Cannes、フランス、06400
        • GSK Investigational Site
      • Chambery、フランス、73000
        • GSK Investigational Site
      • Château Gontier、フランス、53200
        • GSK Investigational Site
      • Clermont-Ferrand、フランス、63003
        • GSK Investigational Site
      • Ecouflant、フランス、49000
        • GSK Investigational Site
      • Gresy sur Aix、フランス、73100
        • GSK Investigational Site
      • La Rochelle、フランス、17000
        • GSK Investigational Site
      • Laval、フランス、53000
        • GSK Investigational Site
      • Le Fousseret、フランス、31430
        • GSK Investigational Site
      • Montpellier Cedex 5、フランス、34295
        • GSK Investigational Site
      • Montreuil Juigne、フランス、49460
        • GSK Investigational Site
      • Muret、フランス、31600
        • GSK Investigational Site
      • Nieul sur Mer、フランス、17137
        • GSK Investigational Site
      • Oignies、フランス、62590
        • GSK Investigational Site
      • Orthez、フランス、64300
        • GSK Investigational Site
      • Paris、フランス、75679
        • GSK Investigational Site
      • Paris Cedex 18、フランス、75877
        • GSK Investigational Site
      • Rosiers d'Egletons、フランス、19300
        • GSK Investigational Site
      • Saint Etienne、フランス、42100
        • GSK Investigational Site
      • Segré、フランス、49500
        • GSK Investigational Site
      • Seysses、フランス、31600
        • GSK Investigational Site
      • Tierce、フランス、49125
        • GSK Investigational Site
      • Tours、フランス、37100
        • GSK Investigational Site
      • Vourey、フランス、38210
        • GSK Investigational Site
  • ベルギー
      • Anthée、ベルギー、5520
        • GSK Investigational Site
      • Deinze、ベルギー、9800
        • GSK Investigational Site
      • Dour、ベルギー、7370
        • GSK Investigational Site
      • Drongen、ベルギー、9031
        • GSK Investigational Site
      • Gent、ベルギー、9000
        • GSK Investigational Site
      • Gozée、ベルギー、6534
        • GSK Investigational Site
      • Hamois (Natoye)、ベルギー、5360
        • GSK Investigational Site
      • Kerksken、ベルギー、9451
        • GSK Investigational Site
      • Libramont、ベルギー、6800
        • GSK Investigational Site
      • Linkebeek、ベルギー、1630
        • GSK Investigational Site
      • Maldegem、ベルギー、9990
        • GSK Investigational Site
      • Melsbroek、ベルギー、1820
        • GSK Investigational Site
      • Merelbeke、ベルギー、9820
        • GSK Investigational Site
      • Mettet、ベルギー、5640
        • GSK Investigational Site
      • Oostakker、ベルギー、9041
        • GSK Investigational Site
      • Waarschoot、ベルギー、9950
        • GSK Investigational Site
  • ポーランド
      • Bydgoszcz、ポーランド、85-021
        • GSK Investigational Site
      • Debica、ポーランド、39-200
        • GSK Investigational Site
      • Grodzisk Mazowiecki、ポーランド、05-825
        • GSK Investigational Site
      • Ilawa、ポーランド、14-200
        • GSK Investigational Site
      • Inowrocław、ポーランド、88-100
        • GSK Investigational Site
      • Katowice、ポーランド、40-018
        • GSK Investigational Site
      • Krakow、ポーランド、31-305
        • GSK Investigational Site
      • Krakow、ポーランド、30-695
        • GSK Investigational Site
      • Krakow、ポーランド、31-135
        • GSK Investigational Site
      • Lubartow、ポーランド、21-100
        • GSK Investigational Site
      • Olesnica、ポーランド、56-400
        • GSK Investigational Site
      • Plock、ポーランド、09-400
        • GSK Investigational Site
      • Porabka、ポーランド、43-353
        • GSK Investigational Site
      • Siemianowice Slaskie、ポーランド、41-103
        • GSK Investigational Site
      • Sopot、ポーランド、81-741
        • GSK Investigational Site
      • Torun、ポーランド、87-100
        • GSK Investigational Site
      • Trzebnica、ポーランド、55-100
        • GSK Investigational Site
      • Tychy、ポーランド、43-100
        • GSK Investigational Site
      • Wroclaw、ポーランド、50-088
        • GSK Investigational Site
  • メキシコ
      • Mexico、メキシコ、14000
        • GSK Investigational Site
    • Estado De México
      • Ecatepec de Morelos、Estado De México、メキシコ、55075
        • GSK Investigational Site
    • Morelos
      • Cuernavaca、Morelos、メキシコ
        • GSK Investigational Site
    • Nuevo León
      • Monterrey、Nuevo León、メキシコ、64610
        • GSK Investigational Site
  • ルーマニア
      • Braila、ルーマニア、810384
        • GSK Investigational Site
      • Braila、ルーマニア、810019
        • GSK Investigational Site
      • Brasov、ルーマニア、500260
        • GSK Investigational Site
      • Brasov、ルーマニア、500366
        • GSK Investigational Site
      • Brasov、ルーマニア、500014
        • GSK Investigational Site
      • Bucharest、ルーマニア、020142
        • GSK Investigational Site
      • Bucharest、ルーマニア、062289
        • GSK Investigational Site
      • Bucharest、ルーマニア、077190
        • GSK Investigational Site
      • Bucharest、ルーマニア、010194
        • GSK Investigational Site
      • Craiova、ルーマニア、200128
        • GSK Investigational Site
      • Galati、ルーマニア、800578
        • GSK Investigational Site
      • Galati、ルーマニア、800338
        • GSK Investigational Site
      • Pantelimon、ルーマニア、77145
        • GSK Investigational Site
      • Ploiesti、ルーマニア、100172
        • GSK Investigational Site
  • ロシア連邦
      • Barnaul、ロシア連邦、656056
        • GSK Investigational Site
      • Ekaterinburg、ロシア連邦、620137
        • GSK Investigational Site
      • Ekaterinburg、ロシア連邦
        • GSK Investigational Site
      • Perm、ロシア連邦、614010
        • GSK Investigational Site
      • Perm、ロシア連邦、614087
        • GSK Investigational Site
  • 台湾
      • Taipei、台湾、100
        • GSK Investigational Site
      • Taipei、台湾、112
        • GSK Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年歳以上 (高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • A man or woman aged 65 years or older at the time of the vaccination.
  • Written informed consent obtained from the subject.
  • Subjects with residence status allowing free mixing with general community.

Exclusion Criteria:

  • Bedridden subjects
  • Previous vaccination against influenza since February 2008.
  • Previous vaccination in the last three years with an investigational adjuvanted candidate seasonal or pandemic influenza vaccine.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Any contra-indication to intramuscular administration of the influenza vaccines.
  • History of hypersensitivity to a previous dose of influenza vaccine.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg and chicken protein.
  • Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：FluNG Group
subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
生物学的：GSK Bio's influenza vaccine GSK2186877A
IM administration, two times one annual dose, 3 different lots will be tested
アクティブコンパレータ：Fluarix Group
subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
生物学的：Fluarix TM
IM administration, two times one annual dose

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.
時間枠：After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))
Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.
After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))
Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.
時間枠：At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study
Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the lot-to-lot subset of subjects.
At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.
時間枠：During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)
Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.
During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)
Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.
時間枠：During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)
Occurrence of culture-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). Culture-confirmed influenza (CCI) was defined as an episode of ILI occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by viral culture analysis.
During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)
Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.
時間枠：During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)

Clinical influenza= An ILI episode (with an ILI onset from the 15th of November until the end of the surveillance period) with at least simultaneously fever (oral temperature of ≥37.8 degrees Celsius) and cough.

The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v).
During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)
Number of Subjects Reporting All-cause Death After the First Dose of Vaccine.
時間枠：During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)
The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v).
During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)
Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine
時間枠：During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)
Respiratory disease: A diagnosis of respiratory disease included: acute respiratory infections, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system. In case the event has a fatal outcome, the diagnosis can also be confirmed by autopsy.
During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).
時間枠：Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009)

Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination
Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009)
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).
時間枠：Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010)

Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination
Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010)
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).
時間枠：During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)

Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination
During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)
Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs).
時間枠：During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

Related = event assessed by the investigator as causally related to the study vaccination
During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms.
時間枠：During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter
During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
Number of Days With Any Grade of Solicited Local Symptoms
時間枠：During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
Solicited local symptoms assessed were ecchymosis, pain, redness and swelling
During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms
時間枠：During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter
During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Number of Days With Any Grade of Solicited Local Symptoms.
時間枠：During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Solicited local symptoms assessed were ecchymosis, pain, redness and swelling.
During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms
時間枠：During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C.
During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
Number of Days With Any Grade of Solicited General Symptoms
時間枠：During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.
During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.
時間枠：During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C.
During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Number of Days With Any Grade of Solicited General Symptoms.
時間枠：During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.
During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).
時間枠：Within 21 days (Days 0-20) after the first dose (Year 2008/2009)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.
Within 21 days (Days 0-20) after the first dose (Year 2008/2009)
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).
時間枠：Within 21 days (Days 0-20) after the second dose (Year 2009/2010)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.
Within 21 days (Days 0-20) after the second dose (Year 2009/2010)
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit
時間枠：Within 180 days (Days 0-179) after the first dose (Year 2008/2009)
For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.
Within 180 days (Days 0-179) after the first dose (Year 2008/2009)
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit.
時間枠：Within 180 days (Days 0-179) after the second dose (Year 2009/2010)
For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.
Within 180 days (Days 0-179) after the second dose (Year 2009/2010)
Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.
時間枠：At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study
Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects.
At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study
Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains
時間枠：At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study
Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects.
At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study
Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.
時間枠：At Days 0 (pre-vaccination Dose 1), 21 (post-vaccination Dose 1) and 180 (post-vaccination Dose 1) of the first year (2008/2009) of the study
Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.
At Days 0 (pre-vaccination Dose 1), 21 (post-vaccination Dose 1) and 180 (post-vaccination Dose 1) of the first year (2008/2009) of the study
Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.
時間枠：At Days 0 (pre-vaccination Dose 2), 21 (post-vaccination Dose 2) and 180 (post-vaccination Dose 2) of the second year (2009/2010) of the study
Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.
At Days 0 (pre-vaccination Dose 2), 21 (post-vaccination Dose 2) and 180 (post-vaccination Dose 2) of the second year (2009/2010) of the study
Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains
時間枠：At Day 21 of the first year (2008/2009) of the study.
In the lot-to-lot subset of subject in the FluGN Group. Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Seroconversion is defined as the number of subjects with pre-vaccination HI titer (Day 0) < 1:10 and post-vaccination titer (Day 21) ≥ 1:40 or a pre-vaccination HI titer (Day 0) ≥ 1:10 and fold-increase (post/pre) ≥ 4.
At Day 21 of the first year (2008/2009) of the study.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

GlaxoSmithKline

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2008年9月15日

一次修了 (実際)

2010年6月18日

研究の完了 (実際)

2011年1月5日

試験登録日

最初に提出

2008年9月12日

QC基準を満たした最初の提出物

2008年9月12日

最初の投稿 (見積もり)

2008年9月16日

学習記録の更新

投稿された最後の更新 (実際)

2018年6月8日

QC基準を満たした最後の更新が送信されました

2018年5月8日

最終確認日

2017年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 106372

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

試験データ・資料

  1. 注釈付き症例報告書
    情報識別子：106372
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  2. インフォームド コンセント フォーム
    情報識別子：106372
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  3. 統計分析計画
    情報識別子：106372
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  4. 臨床研究報告書
    情報識別子：106372
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  5. データセット仕様
    情報識別子：106372
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  6. 個人参加者データセット
    情報識別子：106372
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  7. 研究プロトコル
    情報識別子：106372
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

GSK Bio's influenza vaccine GSK2186877Aの臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Jordan

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

3
購読する