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

8. maj 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Influenza

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

43695

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Forebyggelse
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Firedobbelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: 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).	Biologisk: GSK Bio's influenza vaccine GSK2186877A IM administration, two times one annual dose, 3 different lots will be tested
Aktiv komparator: 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).	Biologisk: Fluarix TM IM administration, two times one annual dose

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. Tidsramme: 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. Tidsramme: 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

Sekundære resultatmål

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. september 2008

Primær færdiggørelse (Faktiske)

18. juni 2010

Studieafslutning (Faktiske)

5. januar 2011

Datoer for studieregistrering

Først indsendt

12. september 2008

Først indsendt, der opfyldte QC-kriterier

12. september 2008

Først opslået (Skøn)

16. september 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2018

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

106372

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

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

Studiedata/dokumenter

Annoteret sagsbetænkningsformular
Informations-id: 106372

Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Formular til informeret samtykke
Informations-id: 106372

Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Statistisk analyseplan
Informations-id: 106372

Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Klinisk undersøgelsesrapport
Informations-id: 106372

Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Datasætspecifikation
Informations-id: 106372

Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Individuelt deltagerdatasæt
Informations-id: 106372

Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Studieprotokol
Informations-id: 106372

Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Influenza

Gamaleya Research Institute of Epidemiology and...

Afsluttet

Undersøgelsen af sikkerheden, reaktogeniciteten og immunogeniciteten af GamFluVac

Influenza A | Influenza A-virusinfektion | Influenza epidemi | Influenza H5N1

Den Russiske Føderation
NPO Petrovax

Afsluttet

En undersøgelse for at bevise ikke-inferiør immunogenicitet af Grippol Quadrivalent sammenlignet med Grippol Plus

Vaccine reaktion | Influenza | Influenza, menneske | Influenza A | Akut luftvejsinfektion | Influenza type B | Influenza | Influenza A H3N2 | Influenza A H1N1 | Influenza, menneske | Influenza epidemi

Den Russiske Føderation
Vanderbilt University Medical Center
Human Vaccines Project

Afsluttet

Kinetik af immunresponset på inaktiveret influenzavaccine hos raske voksne (KIRV)

Vaccine reaktion | Influenza | Influenza, menneske | Influenza A | Influenza type B | Influenza A H3N2 | Influenza A H1N1

Forenede Stater
Novartis Vaccines

Afsluttet

Humoral og cellemedieret immunitet og sikkerhed af MF59C.1-adjuveret subunit influenzavaccine eller en konventionel subunit influenzavaccine hos tidligere uvaccinerede raske forsøgspersoner

Influenza | Sæsonbestemt influenza | Menneskelig influenza | Influenza på grund af uspecificeret influenzavirus

Belgien
Seqirus
Novartis Vaccines

Afsluttet

Sikkerhed og immunogenicitet af to doser aH5N1-vaccine hos voksne og ældre forsøgspersoner med og uden immunsuppressive tilstande *aH5N1:Monovalent H5N1-influenzavaccine

Influenza | Influenza, menneske | Influenza A-virus, H5N1-undertype | Influenza, menneske | Influenza, fugle

Australien, Tyskland, Italien
Novartis Vaccines
Novartis Vaccines and Diagnostics (formerly Chiron Vaccines)

Afsluttet

Undersøgelse af sikkerheden og immunogeniciteten af en influenzavaccine administreret til raske voksne

Influenza sygdom; Influenza

Forenede Stater
Quidel Corporation

Afsluttet

QuickVue Influenza A + B Test Field Study (QuickVue Flu)

Influenza A, Influenza B

Forenede Stater
National Institute of Allergy and Infectious Diseases...

Afsluttet

Sikkerhed og effektivitet af undersøgelsesbaseret anti-influenza immunplasma til behandling af influenza (IRC002)

Influenza A | Influenza B

Forenede Stater
Ellume Pty Ltd

Afsluttet

Validering af Ellume® Respirio Flu Test og Ellume® eLab Flu Test til hurtig identifikation af influenza A/B

Influenza A | Influenza B

Australien
Virginia Commonwealth University

Afsluttet

Characteristics and Outcomes of Intensive Care Unit Patients Admitted With Novel H1N1 Influenza or Seasonal Influenza

Sæsonbestemt influenza | H1N1 influenza

Forenede Stater

Kliniske forsøg med GSK Bio's influenza vaccine GSK2186877A

GlaxoSmithKline

Afsluttet

Klinisk undersøgelse af immunogeniciteten af GSK Biologicals' influenzavaccine GSK2186877A hos personer i alderen 65 år eller ældre

Influenza

Spanien, Forenede Stater
GlaxoSmithKline

Afsluttet

Undersøgelse til evaluering af immunogeniciteten og sikkerheden af en undersøgelsesinfluenzavaccine til ældre

Influenza

Estland, Slovakiet
GlaxoSmithKline

Afsluttet

Evaluering af sikkerhed og immunogenicitet af GSK Biologicals' influenzavaccine GSK2186877A hos voksne 65 år og ældre

Influenza

Tyskland, Sverige, Holland
GlaxoSmithKline

Afsluttet

Evaluering af sikkerheden og immunogeniciteten af influenzavaccinen GSK2186877A hos ældre

Influenza

Tyskland, Forenede Stater, Belgien, Norge
University Hospital, Geneva

Afsluttet

Vaccinerespons på influenza A H1N1/09-vaccination hos højrisikopatienter

HIV-infektion | Kræft | Transplantation | Pædiatri | Reumatisk sygdom

Schweiz
GlaxoSmithKline

Afsluttet

Immunogenicitet og reaktogenicitet af GlaxoSmithKline (GSK) Biologicals' Quadrivalent Split Virion-influenzavaccine Fluarix Tetra (2015-sæsonen sydlige halvkugle) hos voksne 18 år og derover

Influenza

Brasilien
GlaxoSmithKline

Afsluttet

Sammenligning af GSKBiologicals' Hib-MenCY-TT-vaccine vs licenseret Hib-konjugat eller meningokokvaccine

Neisseria Meningitidis | Haemophilus Influenzae Type b

Forenede Stater

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. Tidsramme: 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. Tidsramme: 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. Tidsramme: 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. Tidsramme: 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 Tidsramme: 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). Tidsramme: 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). Tidsramme: 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). Tidsramme: 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). Tidsramme: 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. Tidsramme: 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 Tidsramme: 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 Tidsramme: 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. Tidsramme: 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 Tidsramme: 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 Tidsramme: 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. Tidsramme: 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. Tidsramme: 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). Tidsramme: 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). Tidsramme: 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 Tidsramme: 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. Tidsramme: 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. Tidsramme: 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 Tidsramme: 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. Tidsramme: 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. Tidsramme: 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 Tidsramme: 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.

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

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

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Publikationer og nyttige links

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

Studiedata/dokumenter

Kliniske forsøg med Influenza

Kliniske forsøg med GSK Bio's influenza vaccine GSK2186877A

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Philippines

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer