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AzTrials

InfluenzaPhase 3NCT00753272

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

A Phase 3 study testing GSK Bio's influenza vaccine GSK2186877A and Fluarix TM in people with Influenza, run by GlaxoSmithKline at 274 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
GSK Bio's influenza vaccine GSK2186877A and Fluarix TM
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43,695 participants
Where
274 sitesin 15 countries
Study dates
15 Sep 2008to 5 Jan 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

274 sites in 15 countries.

274 sites in 15 countries

Germany79 sites

  • GSK Investigational Site

    Augsburg, Bavaria, 86150

  • GSK Investigational Site

    Bad Bramstedt, Schleswig-Holstein, 24576

  • GSK Investigational Site

    Bad Kreuznach, Hesse, 55545

  • GSK Investigational Site

    Bad Segeberg, Schleswig-Holstein, 23795

  • GSK Investigational Site

    Berlin, 10365

  • GSK Investigational Site

    Berlin, 10367

  • GSK Investigational Site

    Berlin, 10435

  • GSK Investigational Site

    Berlin, 10629

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 10777

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 12157

  • GSK Investigational Site

    Berlin, 12627

  • GSK Investigational Site

    Berlin, 13086

  • GSK Investigational Site

    Berlin, 13125

  • GSK Investigational Site

    Berlin, 13347

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44787

  • GSK Investigational Site

    Borna, Saxony, 04552

  • GSK Investigational Site

    Brinkum/Stuhr, Lower Saxony, 28816

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 51063

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 51069

  • GSK Investigational Site

    Cottbus, Brandenburg, 03050

  • GSK Investigational Site

    Delitzsch, Saxony, 04509

  • GSK Investigational Site

    Dresden, Saxony, 01069

  • GSK Investigational Site

    Dresden, Saxony, 01099

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Duelmen, Lower Saxony, 48249

  • GSK Investigational Site

    Erfurt, Thuringia, 99084

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Flörsheim, Hesse, 65439

  • GSK Investigational Site

    Freiberg, Saxony, 09599

  • GSK Investigational Site

    Freital, Saxony, 01705

  • GSK Investigational Site

    Geringswalde, Saxony, 09326

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Güglingen, Baden-Wurttemberg, 74363

  • GSK Investigational Site

    Haag, Bavaria, 83527

  • GSK Investigational Site

    Hamburg, 20246

  • GSK Investigational Site

    Hamburg, 20253

  • GSK Investigational Site

    Hamburg, 22143

  • GSK Investigational Site

    Hamburg, 22335

  • GSK Investigational Site

    Hamburg, 22339

  • GSK Investigational Site

    Hamburg, 22415

  • GSK Investigational Site

    Hamburg, 22769

  • GSK Investigational Site

    Höhenkirchen-Siegertsbrunn, Bavaria, 85635

  • GSK Investigational Site

    Ingelheim, Rhineland-Palatinate, 55218

  • GSK Investigational Site

    Kallstadt, Rhineland-Palatinate, 67169

  • GSK Investigational Site

    Ketzin, Brandenburg, 14669

  • GSK Investigational Site

    Koenigslutter, Lower Saxony, 38154

  • GSK Investigational Site

    Köthen, Saxony-Anhalt, 06366

  • GSK Investigational Site

    Künzing, Bavaria, 94550

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Leipzig, Saxony, 04207

  • GSK Investigational Site

    Leipzig, Saxony, 04315

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23554

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39104

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55116

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68161

  • GSK Investigational Site

    Messkirch, Baden-Wurttemberg, 88605

  • GSK Investigational Site

    Munich, Bavaria, 80339

  • GSK Investigational Site

    Munich, Bavaria, 80636

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48155

  • GSK Investigational Site

    Rednitzhembach, Bavaria, 91126

  • GSK Investigational Site

    Rhaunen, Rhineland-Palatinate, 55624

  • GSK Investigational Site

    Rostock, Mecklenburg-Vorpommern, 18057

  • GSK Investigational Site

    Rotenburg (Wümme), Lower Saxony, 27356

  • GSK Investigational Site

    Rudersberg, Baden-Wurttemberg, 73635

  • GSK Investigational Site

    Rüdersdorf, Brandenburg, 15562

  • GSK Investigational Site

    Schmiedeberg, Saxony, 01762

  • GSK Investigational Site

    Schwerin, Mecklenburg-Vorpommern, 19055

  • GSK Investigational Site

    Schwetzingen, Baden-Wurttemberg, 68723

  • GSK Investigational Site

    Sinsheim, Baden-Wurttemberg, 74889

  • GSK Investigational Site

    Tübingen, Baden-Wurttemberg, 72074

  • GSK Investigational Site

    Weinheim, Baden-Wurttemberg, 69469

  • GSK Investigational Site

    Weißenberg, Saxony, 02627

  • GSK Investigational Site

    Witten, North Rhine-Westphalia, 58455

  • GSK Investigational Site

    Wolmirstedt, Saxony-Anhalt, 39326

  • GSK Investigational Site

    Würzburg, Bavaria, 97070

Other trials in Germany

United States63 sites

  • GSK Investigational Site

    Alabaster, Alabama, 35007

  • GSK Investigational Site

    Anaheim, California, 92801

  • GSK Investigational Site

    Boise, Idaho, 83642

  • GSK Investigational Site

    Camillus, New York, 13031

  • GSK Investigational Site

    Carnegie, Pennsylvania, 15106

  • GSK Investigational Site

    Cary, North Carolina, 27518

  • GSK Investigational Site

    Chandler, Arizona, 85224

  • GSK Investigational Site

    Charleston, South Carolina, 29412

  • GSK Investigational Site

    Charlotte, North Carolina, 28209

  • GSK Investigational Site

    Clearwater, Florida, 33761

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Crystal River, Florida, 34429

  • GSK Investigational Site

    Delray Beach, Florida, 33484

  • GSK Investigational Site

    Endwell, New York, 13760

  • GSK Investigational Site

    Erie, Pennsylvania, 16506

  • GSK Investigational Site

    Grove City, Pennsylvania, 16127

  • GSK Investigational Site

    Hackensack, New Jersey, 07601

  • GSK Investigational Site

    Hickory, North Carolina, 28601

  • GSK Investigational Site

    Hot Springs, Arkansas, 71901

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Huntsville, Alabama, 35802

  • GSK Investigational Site

    Inverness, Florida, 34452

  • GSK Investigational Site

    Jacksonville, Florida, 32205

  • GSK Investigational Site

    Jacksonville, Florida, 32216

  • GSK Investigational Site

    Jefferson Hills, Pennsylvania, 15025

  • GSK Investigational Site

    Johnson City, New York, 13790

  • GSK Investigational Site

    Kansas City, Missouri, 64114

  • GSK Investigational Site

    Las Vegas, Nevada, 89104

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Marshfield, Wisconsin, 54449

  • GSK Investigational Site

    Mesa, Arizona, 85203

  • GSK Investigational Site

    Mesa, Arizona, 85213

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    North Myrtle Beach, South Carolina, 29582

  • GSK Investigational Site

    Omaha, Nebraska, 68134

  • GSK Investigational Site

    Overland Park, Kansas, 66212

  • GSK Investigational Site

    Pembroke Pines, Florida, 33024

  • GSK Investigational Site

    Peoria, Illinois, 61602

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19102

  • GSK Investigational Site

    Phoenix, Arizona, 85020

  • GSK Investigational Site

    Phoenix, Arizona, 85028

  • GSK Investigational Site

    Phoenix, Arizona, 85050

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15205

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15236

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15241

  • GSK Investigational Site

    Raleigh, North Carolina, 27609

  • GSK Investigational Site

    Raleigh, North Carolina, 27612

  • GSK Investigational Site

    Rochester, New York, 14621

  • GSK Investigational Site

    Salisbury, North Carolina, 28144

  • GSK Investigational Site

    Salt Lake City, Utah, 84109

  • GSK Investigational Site

    Salt Lake City, Utah, 84121

  • GSK Investigational Site

    Santa Ana, California, 92705

  • GSK Investigational Site

    Somers Point, New Jersey, 08244

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    St Louis, Missouri, 63104

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Tabor City, North Carolina, 28463

  • GSK Investigational Site

    Tempe, Arizona, 85283

  • GSK Investigational Site

    Uniontown, Pennsylvania, 15401

  • GSK Investigational Site

    Upper Saint Clair, Pennsylvania, 15241

  • GSK Investigational Site

    Warwick, Rhode Island, 02886

  • GSK Investigational Site

    West Jordan, Utah, 84088

  • GSK Investigational Site

    Wichita, Kansas, 67207

Other trials in United States

France30 sites

  • GSK Investigational Site

    Angers, 49000

  • GSK Investigational Site

    Angers, 49100

  • GSK Investigational Site

    Anzin, 59410

  • GSK Investigational Site

    Arras, 62000

  • GSK Investigational Site

    Bécon-les-Granits, 49370

  • GSK Investigational Site

    Bordeaux, 33200

  • GSK Investigational Site

    Cannes, 06400

  • GSK Investigational Site

    Chambéry, 73000

  • GSK Investigational Site

    Château-Gontier, 53200

  • GSK Investigational Site

    Clermont-Ferrand, 63003

  • GSK Investigational Site

    Écouflant, 49000

  • GSK Investigational Site

    Grésy-sur-Aix, 73100

  • GSK Investigational Site

    La Rochelle, 17000

  • GSK Investigational Site

    Laval, 53000

  • GSK Investigational Site

    Le Fousseret, 31430

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Montreuil-Juigné, 49460

  • GSK Investigational Site

    Muret, 31600

  • GSK Investigational Site

    Nieul-sur-Mer, 17137

  • GSK Investigational Site

    Oignies, 62590

  • GSK Investigational Site

    Orthez, 64300

  • GSK Investigational Site

    Paris, 75679

  • GSK Investigational Site

    Paris, 75877

  • GSK Investigational Site

    Rosiers-d'Égletons, 19300

  • GSK Investigational Site

    Saint-Etienne, 42100

  • GSK Investigational Site

    Segré, 49500

  • GSK Investigational Site

    Seysses, 31600

  • GSK Investigational Site

    Tiercé, 49125

  • GSK Investigational Site

    Tours, 37100

  • GSK Investigational Site

    Vourey, 38210

Other trials in France

Poland19 sites

  • GSK Investigational Site

    Bydgoszcz, 85-021

  • GSK Investigational Site

    Dębica, 39-200

  • GSK Investigational Site

    Grodzisk Mazowiecki, 05-825

  • GSK Investigational Site

    Iława, 14-200

  • GSK Investigational Site

    Inowrocław, 88-100

  • GSK Investigational Site

    Katowice, 40-018

  • GSK Investigational Site

    Krakow, 30-695

  • GSK Investigational Site

    Krakow, 31-135

  • GSK Investigational Site

    Krakow, 31-305

  • GSK Investigational Site

    Lubartów, 21-100

  • GSK Investigational Site

    Oleśnica, 56-400

  • GSK Investigational Site

    Płock, 09-400

  • GSK Investigational Site

    Porąbka, 43-353

  • GSK Investigational Site

    Siemianowice Śląskie, 41-103

  • GSK Investigational Site

    Sopot, 81-741

  • GSK Investigational Site

    Torun, 87-100

  • GSK Investigational Site

    Trzebnica, 55-100

  • GSK Investigational Site

    Tychy, 43-100

  • GSK Investigational Site

    Wroclaw, 50-088

Other trials in Poland

Belgium16 sites

  • GSK Investigational Site

    Anthée, 5520

  • GSK Investigational Site

    Deinze, 9800

  • GSK Investigational Site

    Dour, 7370

  • GSK Investigational Site

    Drongen, 9031

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Gozée, 6534

  • GSK Investigational Site

    Kerksken, 9451

  • GSK Investigational Site

    Libramont, 6800

  • GSK Investigational Site

    Linkebeek, 1630

  • GSK Investigational Site

    Maldegem, 9990

  • GSK Investigational Site

    Melsbroek, 1820

  • GSK Investigational Site

    Merelbeke, 9820

  • GSK Investigational Site

    Mettet, 5640

  • GSK Investigational Site

    Natoye, 5360

  • GSK Investigational Site

    Oostakker, 9041

  • GSK Investigational Site

    Waarschoot, 9950

Other trials in Belgium

Romania14 sites

  • GSK Investigational Site

    Brăila, 810019

  • GSK Investigational Site

    Brăila, 810384

  • GSK Investigational Site

    Brasov, 500014

  • GSK Investigational Site

    Brasov, 500260

  • GSK Investigational Site

    Brasov, 500366

  • GSK Investigational Site

    Bucharest, 010194

  • GSK Investigational Site

    Bucharest, 020142

  • GSK Investigational Site

    Bucharest, 062289

  • GSK Investigational Site

    Bucharest, 077190

  • GSK Investigational Site

    Craiova, 200128

  • GSK Investigational Site

    Galati, 800338

  • GSK Investigational Site

    Galati, 800578

  • GSK Investigational Site

    Pantelimon, 77145

  • GSK Investigational Site

    Ploieşti, 100172

Other trials in Romania

Canada12 sites

  • GSK Investigational Site

    Bay Roberts, Newfoundland and Labrador, A0A 1G0

  • GSK Investigational Site

    Brampton, Ontario, L6T 3T1

  • GSK Investigational Site

    Coquitlam, British Columbia, V3K 3P4

  • GSK Investigational Site

    Gatineau, Quebec, J8Y 6S8

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E 1H5

  • GSK Investigational Site

    Halifax, Nova Scotia, B3K 6R8

  • GSK Investigational Site

    Québec, Quebec, G1W 4R4

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 4J6

  • GSK Investigational Site

    St-Romulad, Quebec, G6W 5M6

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Norway9 sites

  • GSK Investigational Site

    Ålesund

  • GSK Investigational Site

    Bekkestua, 1319

  • GSK Investigational Site

    Bergen, 5094

  • GSK Investigational Site

    Elverum, 2408

  • GSK Investigational Site

    Hamar, 2317

  • GSK Investigational Site

    Oslo, 0277

  • GSK Investigational Site

    Oslo, 0484

  • GSK Investigational Site

    Skien, 3717

  • GSK Investigational Site

    Stavanger, 4005

Other trials in Norway

Estonia7 sites

  • GSK Investigational Site

    Saku, 75501

  • GSK Investigational Site

    Tallinn, 10117

  • GSK Investigational Site

    Tallinn, 10617

  • GSK Investigational Site

    Tallinn, 13419

  • GSK Investigational Site

    Tallinn, 13619

  • GSK Investigational Site

    Tartu, 50106

  • GSK Investigational Site

    Tartu, 50410

Other trials in Estonia

Czechia6 sites

  • GSK Investigational Site

    Hradec Králové, 500 03

  • GSK Investigational Site

    Jaroměř, 551 02

  • GSK Investigational Site

    Jaroměř

  • GSK Investigational Site

    Pardubice, 530 02

  • GSK Investigational Site

    Pardubice, 530 12

  • GSK Investigational Site

    Pardubice

Other trials in Czechia

Russia5 sites

  • GSK Investigational Site

    Barnaul, 656056

  • GSK Investigational Site

    Perm, 614010

  • GSK Investigational Site

    Perm, 614087

  • GSK Investigational Site

    Yekaterinburg, 620137

  • GSK Investigational Site

    Yekaterinburg

Other trials in Russia

Mexico4 sites

  • GSK Investigational Site

    Cuernavaca, Morelos

  • GSK Investigational Site

    Ecatepec de Morelos, State of Mexico, 55075

  • GSK Investigational Site

    México, 14000

  • GSK Investigational Site

    Monterrey, Nuevo León, 64610

Other trials in Mexico

Netherlands4 sites

  • GSK Investigational Site

    Rotterdam, 3001 DC

  • GSK Investigational Site

    Rotterdam, 3011 EN

  • GSK Investigational Site

    Soest, 3762 BN

  • GSK Investigational Site

    Utrecht, 3584 CX

Other trials in Netherlands

United Kingdom4 sites

  • GSK Investigational Site

    Buckshaw Village, Chorley, Lancashire, PR7 7NA

  • GSK Investigational Site

    Liverpool, Merseyside, L22 0LG

  • GSK Investigational Site

    Reading, Berkshire, RG2 0TG

  • GSK Investigational Site

    Waterloo, Liverpool, L22 0LG

Other trials in United Kingdom

Taiwan2 sites

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei, 112

Other trials in Taiwan

About this study

Official title: 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.

Read the detailed description

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.

Conditions
Influenza
Being tested
GSK Bio's influenza vaccine GSK2186877A, Fluarix TM
Keywords
Efficacy, Influenza Vaccines, Influenza, Vaccine, Elderly
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK Bio's influenza vaccine GSK2186877ABiological

    IM administration, two times one annual dose, 3 different lots will be tested

  • Fluarix TMBiological

    IM administration, two times one annual dose

Study groups in NCT00753272
Study groupRoleWhat they receive
FluNG GroupExperimentalsubjects 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).
Receives: Biological: GSK Bio's influenza vaccine GSK2186877A
Fluarix GroupActive comparatorsubjects 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).
Receives: Biological: Fluarix TM

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))

  2. Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.

    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.

    Measured: At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study

Secondary outcomes (26)

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

    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.

    Measured: During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)

  2. Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.

    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.

    Measured: During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)

  3. Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.

    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).

    Measured: 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)

  4. Number of Subjects Reporting All-cause Death After the First Dose of Vaccine.

    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).

    Measured: 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)

  5. Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine

    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.

    Measured: 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)

  6. Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).

    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

    Measured: Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009)

  7. Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).

    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

    Measured: Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010)

  8. Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).

    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

    Measured: During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)

  9. Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs).

    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

    Measured: During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)

  10. Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms.

    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

    Measured: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)

  11. Number of Days With Any Grade of Solicited Local Symptoms

    Solicited local symptoms assessed were ecchymosis, pain, redness and swelling

    Measured: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)

  12. Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms

    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

    Measured: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)

  13. Number of Days With Any Grade of Solicited Local Symptoms.

    Solicited local symptoms assessed were ecchymosis, pain, redness and swelling.

    Measured: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)

  14. Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms

    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.

    Measured: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)

  15. Number of Days With Any Grade of Solicited General Symptoms

    Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.

    Measured: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)

  16. Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.

    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.

    Measured: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)

  17. Number of Days With Any Grade of Solicited General Symptoms.

    Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.

    Measured: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)

  18. Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).

    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.

    Measured: Within 21 days (Days 0-20) after the first dose (Year 2008/2009)

  19. Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).

    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.

    Measured: Within 21 days (Days 0-20) after the second dose (Year 2009/2010)

  20. Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit

    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.

    Measured: Within 180 days (Days 0-179) after the first dose (Year 2008/2009)

  21. Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit.

    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.

    Measured: Within 180 days (Days 0-179) after the second dose (Year 2009/2010)

  22. Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.

    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.

    Measured: At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study

  23. Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains

    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.

    Measured: At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study

  24. Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.

    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.

    Measured: 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

  25. Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.

    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.

    Measured: 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

  26. Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains

    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.

    Measured: At Day 21 of the first year (2008/2009) of the study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2008 (estimated)
  2. Study start15 Sep 2008
  3. Primary completion18 Jun 2010
  4. Study completion5 Jan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
43,695 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00753272
Sponsor's protocol ID
106372
Status last verified
Aug 2017
First submitted
12 Sep 2008
Last updated
8 Jun 2018
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Ruiz-Palacios GM, Leroux-Roels G, Beran J, Devaster JM, Esen M, Launay O, McElhaney JE, van Essen GA, Benoit A, Claeys C, Dewe W, Durand C, Duval X, Falsey AR, Feldman G, Galtier F, Gervais P, Hwang SJ, McNeil S, Richardus JH, Trofa A, Oostvogels L; Influence65 study group. Immunogenicity of AS03-adjuvanted and non-adjuvanted trivalent inactivated influenza vaccines in elderly adults: A Phase 3, randomized trial and post-hoc correlate of protection analysis. Hum Vaccin Immunother. 2016 Dec;12(12):3043-3055. doi: 10.1080/21645515.2016.1219809.

    PubMed 27690762

  • van Essen GA, Beran J, Devaster JM, Durand C, Duval X, Esen M, Falsey AR, Feldman G, Gervais P, Innis BL, Kovac M, Launay O, Leroux-Roels G, McElhaney JE, McNeil S, Oujaa M, Richardus JH, Ruiz-Palacios G, Osborne RH, Oostvogels L. Influenza symptoms and their impact on elderly adults: randomised trial of AS03-adjuvanted or non-adjuvanted inactivated trivalent seasonal influenza vaccines. Influenza Other Respir Viruses. 2014 Jul;8(4):452-62. doi: 10.1111/irv.12245. Epub 2014 Apr 4.

    PubMed 24702710

  • McElhaney JE, Beran J, Devaster JM, Esen M, Launay O, Leroux-Roels G, Ruiz-Palacios GM, van Essen GA, Caplanusi A, Claeys C, Durand C, Duval X, El Idrissi M, Falsey AR, Feldman G, Frey SE, Galtier F, Hwang SJ, Innis BL, Kovac M, Kremsner P, McNeil S, Nowakowski A, Richardus JH, Trofa A, Oostvogels L; Influence65 study group. AS03-adjuvanted versus non-adjuvanted inactivated trivalent influenza vaccine against seasonal influenza in elderly people: a phase 3 randomised trial. Lancet Infect Dis. 2013 Jun;13(6):485-96. doi: 10.1016/S1473-3099(13)70046-X. Epub 2013 Mar 19.

    PubMed 23518156

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK Bio's influenza vaccine GSK2186877A and Fluarix TM in people with Influenza, run by GlaxoSmithKline at 274 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 274 sites in Germany, United States, France, Poland, Belgium and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. (time frame: After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00753272, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2018.

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