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
1 other identifier
interventional
43,695
15 countries
274
Brief 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 influenza peak season.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2008
274 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2008
CompletedStudy Start
First participant enrolled
September 15, 2008
CompletedFirst Posted
Study publicly available on registry
September 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2011
CompletedResults Posted
Study results publicly available
June 19, 2012
CompletedJune 8, 2018
August 1, 2017
1.8 years
September 12, 2008
April 26, 2012
May 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
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
Secondary Outcomes (26)
Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.
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.
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.
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.
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
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)
- +21 more secondary outcomes
Study Arms (2)
FluNG Group
EXPERIMENTALsubjects 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).
Fluarix Group
ACTIVE 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).
Interventions
IM administration, two times one annual dose, 3 different lots will be tested
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (274)
GSK Investigational Site
Alabaster, Alabama, 35007, United States
GSK Investigational Site
Huntsville, Alabama, 35802, United States
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Mesa, Arizona, 85203, United States
GSK Investigational Site
Mesa, Arizona, 85213, United States
GSK Investigational Site
Phoenix, Arizona, 85020, United States
GSK Investigational Site
Phoenix, Arizona, 85028, United States
GSK Investigational Site
Phoenix, Arizona, 85050, United States
GSK Investigational Site
Tempe, Arizona, 85283, United States
GSK Investigational Site
Hot Springs, Arkansas, 71901, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Anaheim, California, 92801, United States
GSK Investigational Site
Santa Ana, California, 92705, United States
GSK Investigational Site
Clearwater, Florida, 33761, United States
GSK Investigational Site
Coral Gables, Florida, 33134, United States
GSK Investigational Site
Crystal River, Florida, 34429, United States
GSK Investigational Site
Delray Beach, Florida, 33484, United States
GSK Investigational Site
Inverness, Florida, 34452, United States
GSK Investigational Site
Jacksonville, Florida, 32205, United States
GSK Investigational Site
Jacksonville, Florida, 32216, United States
GSK Investigational Site
Pembroke Pines, Florida, 33024, United States
GSK Investigational Site
Boise, Idaho, 83642, United States
GSK Investigational Site
Peoria, Illinois, 61602, United States
GSK Investigational Site
Overland Park, Kansas, 66212, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Kansas City, Missouri, 64114, United States
GSK Investigational Site
St Louis, Missouri, 63104, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Omaha, Nebraska, 68134, United States
GSK Investigational Site
Las Vegas, Nevada, 89104, United States
GSK Investigational Site
Hackensack, New Jersey, 07601, United States
GSK Investigational Site
Somers Point, New Jersey, 08244, United States
GSK Investigational Site
Camillus, New York, 13031, United States
GSK Investigational Site
Endwell, New York, 13760, United States
GSK Investigational Site
Johnson City, New York, 13790, United States
GSK Investigational Site
Rochester, New York, 14621, United States
GSK Investigational Site
Cary, North Carolina, 27518, United States
GSK Investigational Site
Charlotte, North Carolina, 28209, United States
GSK Investigational Site
Hickory, North Carolina, 28601, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Raleigh, North Carolina, 27612, United States
GSK Investigational Site
Salisbury, North Carolina, 28144, United States
GSK Investigational Site
Tabor City, North Carolina, 28463, United States
GSK Investigational Site
Carnegie, Pennsylvania, 15106, United States
GSK Investigational Site
Erie, Pennsylvania, 16506, United States
GSK Investigational Site
Grove City, Pennsylvania, 16127, United States
GSK Investigational Site
Jefferson Hills, Pennsylvania, 15025, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19102, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15205, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Uniontown, Pennsylvania, 15401, United States
GSK Investigational Site
Upper Saint Clair, Pennsylvania, 15241, United States
GSK Investigational Site
Warwick, Rhode Island, 02886, United States
GSK Investigational Site
Charleston, South Carolina, 29412, United States
GSK Investigational Site
North Myrtle Beach, South Carolina, 29582, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
Salt Lake City, Utah, 84121, United States
GSK Investigational Site
West Jordan, Utah, 84088, United States
GSK Investigational Site
Marshfield, Wisconsin, 54449, United States
GSK Investigational Site
Anthée, 5520, Belgium
GSK Investigational Site
Deinze, 9800, Belgium
GSK Investigational Site
Dour, 7370, Belgium
GSK Investigational Site
Drongen, 9031, Belgium
GSK Investigational Site
Ghent, 9000, Belgium
GSK Investigational Site
Gozée, 6534, Belgium
GSK Investigational Site
Kerksken, 9451, Belgium
GSK Investigational Site
Libramont, 6800, Belgium
GSK Investigational Site
Linkebeek, 1630, Belgium
GSK Investigational Site
Maldegem, 9990, Belgium
GSK Investigational Site
Melsbroek, 1820, Belgium
GSK Investigational Site
Merelbeke, 9820, Belgium
GSK Investigational Site
Mettet, 5640, Belgium
GSK Investigational Site
Natoye, 5360, Belgium
GSK Investigational Site
Oostakker, 9041, Belgium
GSK Investigational Site
Waarschoot, 9950, Belgium
GSK Investigational Site
Coquitlam, British Columbia, V3K 3P4, Canada
GSK Investigational Site
Vancouver, British Columbia, V5Z 1M9, Canada
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8, Canada
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2, Canada
GSK Investigational Site
Brampton, Ontario, L6T 3T1, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5, Canada
GSK Investigational Site
Toronto, Ontario, M9W 4L6, Canada
GSK Investigational Site
Gatineau, Quebec, J8Y 6S8, Canada
GSK Investigational Site
Québec, Quebec, G1W 4R4, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 4J6, Canada
GSK Investigational Site
St-Romulad, Quebec, G6W 5M6, Canada
GSK Investigational Site
Hradec Králové, 500 03, Czechia
GSK Investigational Site
Jaroměř, 551 02, Czechia
GSK Investigational Site
Jaroměř, Czechia
GSK Investigational Site
Pardubice, 530 02, Czechia
GSK Investigational Site
Pardubice, 530 12, Czechia
GSK Investigational Site
Pardubice, Czechia
GSK Investigational Site
Saku, 75501, Estonia
GSK Investigational Site
Tallinn, 10117, Estonia
GSK Investigational Site
Tallinn, 10617, Estonia
GSK Investigational Site
Tallinn, 13419, Estonia
GSK Investigational Site
Tallinn, 13619, Estonia
GSK Investigational Site
Tartu, 50106, Estonia
GSK Investigational Site
Tartu, 50410, Estonia
GSK Investigational Site
Angers, 49000, France
GSK Investigational Site
Angers, 49100, France
GSK Investigational Site
Anzin, 59410, France
GSK Investigational Site
Arras, 62000, France
GSK Investigational Site
Bécon-les-Granits, 49370, France
GSK Investigational Site
Bordeaux, 33200, France
GSK Investigational Site
Cannes, 06400, France
GSK Investigational Site
Chambéry, 73000, France
GSK Investigational Site
Château-Gontier, 53200, France
GSK Investigational Site
Clermont-Ferrand, 63003, France
GSK Investigational Site
Écouflant, 49000, France
GSK Investigational Site
Grésy-sur-Aix, 73100, France
GSK Investigational Site
La Rochelle, 17000, France
GSK Investigational Site
Laval, 53000, France
GSK Investigational Site
Le Fousseret, 31430, France
GSK Investigational Site
Montpellier, 34295, France
GSK Investigational Site
Montreuil-Juigné, 49460, France
GSK Investigational Site
Muret, 31600, France
GSK Investigational Site
Nieul-sur-Mer, 17137, France
GSK Investigational Site
Oignies, 62590, France
GSK Investigational Site
Orthez, 64300, France
GSK Investigational Site
Paris, 75679, France
GSK Investigational Site
Paris, 75877, France
GSK Investigational Site
Rosiers-d'Égletons, 19300, France
GSK Investigational Site
Saint-Etienne, 42100, France
GSK Investigational Site
Segré, 49500, France
GSK Investigational Site
Seysses, 31600, France
GSK Investigational Site
Tiercé, 49125, France
GSK Investigational Site
Tours, 37100, France
GSK Investigational Site
Vourey, 38210, France
GSK Investigational Site
Güglingen, Baden-Wurttemberg, 74363, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161, Germany
GSK Investigational Site
Messkirch, Baden-Wurttemberg, 88605, Germany
GSK Investigational Site
Rudersberg, Baden-Wurttemberg, 73635, Germany
GSK Investigational Site
Schwetzingen, Baden-Wurttemberg, 68723, Germany
GSK Investigational Site
Sinsheim, Baden-Wurttemberg, 74889, Germany
GSK Investigational Site
Tübingen, Baden-Wurttemberg, 72074, Germany
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469, Germany
GSK Investigational Site
Augsburg, Bavaria, 86150, Germany
GSK Investigational Site
Haag, Bavaria, 83527, Germany
GSK Investigational Site
Höhenkirchen-Siegertsbrunn, Bavaria, 85635, Germany
GSK Investigational Site
Künzing, Bavaria, 94550, Germany
GSK Investigational Site
Munich, Bavaria, 80339, Germany
GSK Investigational Site
Munich, Bavaria, 80636, Germany
GSK Investigational Site
Rednitzhembach, Bavaria, 91126, Germany
GSK Investigational Site
Würzburg, Bavaria, 97070, Germany
GSK Investigational Site
Cottbus, Brandenburg, 03050, Germany
GSK Investigational Site
Ketzin, Brandenburg, 14669, Germany
GSK Investigational Site
Rüdersdorf, Brandenburg, 15562, Germany
GSK Investigational Site
Bad Kreuznach, Hesse, 55545, Germany
GSK Investigational Site
Flörsheim, Hesse, 65439, Germany
GSK Investigational Site
Brinkum/Stuhr, Lower Saxony, 28816, Germany
GSK Investigational Site
Duelmen, Lower Saxony, 48249, Germany
GSK Investigational Site
Koenigslutter, Lower Saxony, 38154, Germany
GSK Investigational Site
Rotenburg (Wümme), Lower Saxony, 27356, Germany
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18057, Germany
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44787, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51063, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359, Germany
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574, Germany
GSK Investigational Site
Münster, North Rhine-Westphalia, 48155, Germany
GSK Investigational Site
Witten, North Rhine-Westphalia, 58455, Germany
GSK Investigational Site
Ingelheim, Rhineland-Palatinate, 55218, Germany
GSK Investigational Site
Kallstadt, Rhineland-Palatinate, 67169, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624, Germany
GSK Investigational Site
Borna, Saxony, 04552, Germany
GSK Investigational Site
Delitzsch, Saxony, 04509, Germany
GSK Investigational Site
Dresden, Saxony, 01069, Germany
GSK Investigational Site
Dresden, Saxony, 01099, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Freiberg, Saxony, 09599, Germany
GSK Investigational Site
Freital, Saxony, 01705, Germany
GSK Investigational Site
Geringswalde, Saxony, 09326, Germany
GSK Investigational Site
Leipzig, Saxony, 04103, Germany
GSK Investigational Site
Leipzig, Saxony, 04207, Germany
GSK Investigational Site
Leipzig, Saxony, 04315, Germany
GSK Investigational Site
Schmiedeberg, Saxony, 01762, Germany
GSK Investigational Site
Weißenberg, Saxony, 02627, Germany
GSK Investigational Site
Köthen, Saxony-Anhalt, 06366, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39104, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112, Germany
GSK Investigational Site
Wolmirstedt, Saxony-Anhalt, 39326, Germany
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, 24576, Germany
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, 23795, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23554, Germany
GSK Investigational Site
Erfurt, Thuringia, 99084, Germany
GSK Investigational Site
Berlin, 10365, Germany
GSK Investigational Site
Berlin, 10367, Germany
GSK Investigational Site
Berlin, 10435, Germany
GSK Investigational Site
Berlin, 10629, Germany
GSK Investigational Site
Berlin, 10717, Germany
GSK Investigational Site
Berlin, 10777, Germany
GSK Investigational Site
Berlin, 10787, Germany
GSK Investigational Site
Berlin, 12157, Germany
GSK Investigational Site
Berlin, 12627, Germany
GSK Investigational Site
Berlin, 13086, Germany
GSK Investigational Site
Berlin, 13125, Germany
GSK Investigational Site
Berlin, 13347, Germany
GSK Investigational Site
Hamburg, 20246, Germany
GSK Investigational Site
Hamburg, 20253, Germany
GSK Investigational Site
Hamburg, 22143, Germany
GSK Investigational Site
Hamburg, 22335, Germany
GSK Investigational Site
Hamburg, 22339, Germany
GSK Investigational Site
Hamburg, 22415, Germany
GSK Investigational Site
Hamburg, 22769, Germany
GSK Investigational Site
Cuernavaca, Morelos, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64610, Mexico
GSK Investigational Site
Ecatepec de Morelos, State of Mexico, 55075, Mexico
GSK Investigational Site
México, 14000, Mexico
GSK Investigational Site
Rotterdam, 3001 DC, Netherlands
GSK Investigational Site
Rotterdam, 3011 EN, Netherlands
GSK Investigational Site
Soest, 3762 BN, Netherlands
GSK Investigational Site
Utrecht, 3584 CX, Netherlands
GSK Investigational Site
Ålesund, Norway
GSK Investigational Site
Bekkestua, 1319, Norway
GSK Investigational Site
Bergen, 5094, Norway
GSK Investigational Site
Elverum, 2408, Norway
GSK Investigational Site
Hamar, 2317, Norway
GSK Investigational Site
Oslo, 0277, Norway
GSK Investigational Site
Oslo, 0484, Norway
GSK Investigational Site
Skien, 3717, Norway
GSK Investigational Site
Stavanger, 4005, Norway
GSK Investigational Site
Bydgoszcz, 85-021, Poland
GSK Investigational Site
Dębica, 39-200, Poland
GSK Investigational Site
Grodzisk Mazowiecki, 05-825, Poland
GSK Investigational Site
Inowrocław, 88-100, Poland
GSK Investigational Site
Iława, 14-200, Poland
GSK Investigational Site
Katowice, 40-018, Poland
GSK Investigational Site
Krakow, 30-695, Poland
GSK Investigational Site
Krakow, 31-135, Poland
GSK Investigational Site
Krakow, 31-305, Poland
GSK Investigational Site
Lubartów, 21-100, Poland
GSK Investigational Site
Oleśnica, 56-400, Poland
GSK Investigational Site
Porąbka, 43-353, Poland
GSK Investigational Site
Płock, 09-400, Poland
GSK Investigational Site
Siemianowice Śląskie, 41-103, Poland
GSK Investigational Site
Sopot, 81-741, Poland
GSK Investigational Site
Torun, 87-100, Poland
GSK Investigational Site
Trzebnica, 55-100, Poland
GSK Investigational Site
Tychy, 43-100, Poland
GSK Investigational Site
Wroclaw, 50-088, Poland
GSK Investigational Site
Brasov, 500014, Romania
GSK Investigational Site
Brasov, 500260, Romania
GSK Investigational Site
Brasov, 500366, Romania
GSK Investigational Site
Brăila, 810019, Romania
GSK Investigational Site
Brăila, 810384, Romania
GSK Investigational Site
Bucharest, 010194, Romania
GSK Investigational Site
Bucharest, 020142, Romania
GSK Investigational Site
Bucharest, 062289, Romania
GSK Investigational Site
Bucharest, 077190, Romania
GSK Investigational Site
Craiova, 200128, Romania
GSK Investigational Site
Galati, 800338, Romania
GSK Investigational Site
Galati, 800578, Romania
GSK Investigational Site
Pantelimon, 77145, Romania
GSK Investigational Site
Ploieşti, 100172, Romania
GSK Investigational Site
Barnaul, 656056, Russia
GSK Investigational Site
Perm, 614010, Russia
GSK Investigational Site
Perm, 614087, Russia
GSK Investigational Site
Yekaterinburg, 620137, Russia
GSK Investigational Site
Yekaterinburg, Russia
GSK Investigational Site
Taipei, 100, Taiwan
GSK Investigational Site
Taipei, 112, Taiwan
GSK Investigational Site
Reading, Berkshire, RG2 0TG, United Kingdom
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, PR7 7NA, United Kingdom
GSK Investigational Site
Liverpool, Merseyside, L22 0LG, United Kingdom
GSK Investigational Site
Waterloo, Liverpool, L22 0LG, United Kingdom
Related Publications (3)
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.
PMID: 27690762DERIVEDvan 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.
PMID: 24702710DERIVEDMcElhaney 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.
PMID: 23518156DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2008
First Posted
September 16, 2008
Study Start
September 15, 2008
Primary Completion
June 18, 2010
Study Completion
January 5, 2011
Last Updated
June 8, 2018
Results First Posted
June 19, 2012
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.