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

2018. május 8. frissítette: 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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

43695

Fázis

  • 3. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

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

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

65 év és régebbi (Idősebb felnőtt)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Összes

Leírás

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).

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Megelőzés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Négyszeres

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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).
Biológiai: GSK Bio's influenza vaccine GSK2186877A
IM administration, two times one annual dose, 3 different lots will be tested
Aktív összehasonlító: 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).
Biológiai: Fluarix TM
IM administration, two times one annual dose

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.
Időkeret: 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.
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.
Időkeret: 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.
Időkeret: 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.
Időkeret: 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.
Időkeret: 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
Időkeret: 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).
Időkeret: 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).
Időkeret: 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).
Időkeret: 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).
Időkeret: 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.
Időkeret: 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
Időkeret: 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
Időkeret: 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.
Időkeret: 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
Időkeret: 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
Időkeret: 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.
Időkeret: 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.
Időkeret: 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).
Időkeret: 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).
Időkeret: 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
Időkeret: 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.
Időkeret: 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.
Időkeret: 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
Időkeret: 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.
Időkeret: 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.
Időkeret: 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
Időkeret: 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.

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

GlaxoSmithKline

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Hasznos linkek

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2008. szeptember 15.

Elsődleges befejezés (Tényleges)

2010. június 18.

A tanulmány befejezése (Tényleges)

2011. január 5.

Tanulmányi regisztráció dátumai

Először benyújtva

2008. szeptember 12.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2008. szeptember 12.

Első közzététel (Becslés)

2008. szeptember 16.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2018. június 8.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2018. május 8.

Utolsó ellenőrzés

2017. augusztus 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • 106372

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

IGEN

IPD terv leírása

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

Tanulmányi adatok/dokumentumok

  1. Jegyzetekkel ellátott esetjelentési űrlap
    Információs azonosító: 106372
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  2. Tájékozott hozzájárulási űrlap
    Információs azonosító: 106372
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statisztikai elemzési terv
    Információs azonosító: 106372
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  4. Klinikai vizsgálati jelentés
    Információs azonosító: 106372
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  5. Adatkészlet specifikáció
    Információs azonosító: 106372
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  6. Egyéni résztvevő adatkészlet
    Információs azonosító: 106372
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  7. Tanulmányi Protokoll
    Információs azonosító: 106372
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Klinikai vizsgálatok a GSK Bio's influenza vaccine GSK2186877A

Keressen hasonló próbaverziókban

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

CROs by country

CROs in Uganda

Körülmények

Ritka betegségek

Kábítószer-beavatkozások

Táplálék-kiegészítők

Szponzor / közreműködők

Helyek

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