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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00753272
First received: September 12, 2008
Last updated: September 11, 2014
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: GSK Bio's influenza vaccine GSK2186877A
Biological: Fluarix TM
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Observer-blind Superior Efficacy Trial With GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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)) ] [ Designated as safety issue: No ]
    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.

  • Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups. [ Time Frame: At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. [ Time Frame: During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010) ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection. [ Time Frame: During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010) ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine. [ Time Frame: 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) ] [ Designated as safety issue: No ]

    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).


  • Number of Subjects Reporting All-cause Death After the First Dose of Vaccine. [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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).

  • Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID). [ Time Frame: Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009) ] [ Designated as safety issue: No ]

    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


  • Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID). [ Time Frame: Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010) ] [ Designated as safety issue: No ]

    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


  • Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID). [ Time Frame: During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010) ] [ Designated as safety issue: No ]

    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


  • Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010) ] [ Designated as safety issue: No ]

    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


  • Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) ] [ Designated as safety issue: No ]
    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

  • Number of Days With Any Grade of Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were ecchymosis, pain, redness and swelling

  • Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) ] [ Designated as safety issue: No ]
    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

  • Number of Days With Any Grade of Solicited Local Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were ecchymosis, pain, redness and swelling.

  • Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) ] [ Designated as safety issue: No ]
    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.

  • Number of Days With Any Grade of Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.

  • Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) ] [ Designated as safety issue: No ]
    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.

  • Number of Days With Any Grade of Solicited General Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.

  • Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). [ Time Frame: Within 21 days (Days 0-20) after the first dose (Year 2008/2009) ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). [ Time Frame: Within 21 days (Days 0-20) after the second dose (Year 2009/2010) ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit [ Time Frame: Within 180 days (Days 0-179) after the first dose (Year 2008/2009) ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit. [ Time Frame: Within 180 days (Days 0-179) after the second dose (Year 2009/2010) ] [ Designated as safety issue: No ]
    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.

  • Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains. [ Time Frame: At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study ] [ Designated as safety issue: No ]
    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.

  • Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains [ Time Frame: At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study ] [ Designated as safety issue: No ]
    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.

  • Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains. [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.

  • Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains. [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.

  • Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains [ Time Frame: At Day 21 of the first year (2008/2009) of the study. ] [ Designated as safety issue: No ]
    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.


Enrollment: 43695
Study Start Date: September 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Biological: GSK Bio's influenza vaccine GSK2186877A
IM administration, two times one annual dose, 3 different lots will be tested
Active Comparator: 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).
Biological: Fluarix TM
IM administration, two times one annual dose

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753272

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Locations
United States, Alabama
GSK Investigational Site
Alabaster, Alabama, United States, 35007
GSK Investigational Site
Huntsville, Alabama, United States, 35802
GSK Investigational Site
Mobile, Alabama, United States, 36608
United States, Arizona
GSK Investigational Site
Chandler, Arizona, United States, 85224
GSK Investigational Site
Mesa, Arizona, United States, 85213
GSK Investigational Site
Mesa, Arizona, United States, 85203
GSK Investigational Site
Phoenix, Arizona, United States, 85028
GSK Investigational Site
Phoenix, Arizona, United States, 85050
GSK Investigational Site
Phoenix, Arizona, United States, 85020
GSK Investigational Site
Tempe, Arizona, United States, 85283
United States, Arkansas
GSK Investigational Site
Hot Springs, Arkansas, United States, 71901
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Anaheim, California, United States, 92801
GSK Investigational Site
Santa Ana, California, United States, 92705
United States, Florida
GSK Investigational Site
Clearwater, Florida, United States, 33761
GSK Investigational Site
Coral Gables, Florida, United States, 33134
GSK Investigational Site
Crystal River, Florida, United States, 34429
GSK Investigational Site
Delray Beach, Florida, United States, 33484
GSK Investigational Site
Inverness, Florida, United States, 34452
GSK Investigational Site
Jacksonville, Florida, United States, 32216
GSK Investigational Site
Jacksonville, Florida, United States, 32205
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
United States, Idaho
GSK Investigational Site
Boise, Idaho, United States, 83642
United States, Illinois
GSK Investigational Site
Peoria, Illinois, United States, 61602
United States, Kansas
GSK Investigational Site
Overland Park, Kansas, United States, 66212
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, Missouri
GSK Investigational Site
Kansas City, Missouri, United States, 64114
GSK Investigational Site
St. Louis, Missouri, United States, 63141
GSK Investigational Site
St. Louis, Missouri, United States, 63104
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68134
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
United States, New Jersey
GSK Investigational Site
Hackensack, New Jersey, United States, 07601
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
United States, New York
GSK Investigational Site
Camillus, New York, United States, 13031
GSK Investigational Site
Endwell, New York, United States, 13760
GSK Investigational Site
Johnson City, New York, United States, 13790
GSK Investigational Site
Rochester, New York, United States, 14621
United States, North Carolina
GSK Investigational Site
Calabash, North Carolina, United States, 28467
GSK Investigational Site
Cary, North Carolina, United States, 27518
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
GSK Investigational Site
Hickory, North Carolina, United States, 28601
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
GSK Investigational Site
Tabor City, North Carolina, United States, 28463
United States, Pennsylvania
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
GSK Investigational Site
Erie, Pennsylvania, United States, 16506
GSK Investigational Site
Grove City, Pennsylvania, United States, 16127
GSK Investigational Site
Jefferson Hills, Pennsylvania, United States, 15025
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19102
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15205
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
GSK Investigational Site
Uniontown, Pennsylvania, United States, 15401
GSK Investigational Site
Upper St. Clair, Pennsylvania, United States, 15241
United States, Rhode Island
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29412
GSK Investigational Site
North Myrtle Beach, South Carolina, United States, 29582
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
GSK Investigational Site
West Jordan, Utah, United States, 84088
United States, Wisconsin
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Belgium
GSK Investigational Site
Anthée, Belgium, 5520
GSK Investigational Site
Deinze, Belgium, 9800
GSK Investigational Site
Dour, Belgium, 7370
GSK Investigational Site
Drongen, Belgium, 9031
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Gozée, Belgium, 6534
GSK Investigational Site
Hamois (Natoye), Belgium, 5360
GSK Investigational Site
Kerksken, Belgium, 9451
GSK Investigational Site
Libramont, Belgium, 6800
GSK Investigational Site
Linkebeek, Belgium, 1630
GSK Investigational Site
Maldegem, Belgium, 9990
GSK Investigational Site
Melsbroek, Belgium, 1820
GSK Investigational Site
Merelbeke, Belgium, 9820
GSK Investigational Site
Mettet, Belgium, 5640
GSK Investigational Site
Oostakker, Belgium, 9041
GSK Investigational Site
Waarschoot, Belgium, 9950
Canada, British Columbia
GSK Investigational Site
Coquitlam, British Columbia, Canada, V3K 3P4
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Newfoundland and Labrador
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
GSK Investigational Site
Brampton, Ontario, Canada, L6T 3T1
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 1H5
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
GSK Investigational Site
Gatineau, Quebec, Canada, J8Y 6S8
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 4J6
GSK Investigational Site
St-Romulad, Quebec, Canada, G6W 5M6
Canada
GSK Investigational Site
Quebec, Canada, G1W 4R4
Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 03
GSK Investigational Site
Jaroměř, Czech Republic
GSK Investigational Site
Jaroměř, Czech Republic, 551 02
GSK Investigational Site
Pardubice, Czech Republic, 530 12
GSK Investigational Site
Pardubice, Czech Republic, 530 02
GSK Investigational Site
Pardubice, Czech Republic
Estonia
GSK Investigational Site
Saku, Estonia, 75501
GSK Investigational Site
Tallinn, Estonia, 10617
GSK Investigational Site
Tallinn, Estonia, 13419
GSK Investigational Site
Tallinn, Estonia, 13619
GSK Investigational Site
Tallinn, Estonia, 10117
GSK Investigational Site
Tartu, Estonia, 50410
GSK Investigational Site
Tartu, Estonia, 50106
France
GSK Investigational Site
Angers, France, 49100
GSK Investigational Site
Angers, France, 49000
GSK Investigational Site
Anzin, France, 59410
GSK Investigational Site
Arras, France, 62000
GSK Investigational Site
Bordeaux, France, 33200
GSK Investigational Site
Bécon les Granits, France, 49370
GSK Investigational Site
Cannes, France, 06400
GSK Investigational Site
Chambery, France, 73000
GSK Investigational Site
Château Gontier, France, 53200
GSK Investigational Site
Clermont-Ferrand, France, 63003
GSK Investigational Site
Ecouflant, France, 49000
GSK Investigational Site
Gresy sur Aix, France, 73100
GSK Investigational Site
La Rochelle, France, 17000
GSK Investigational Site
Laval, France, 53000
GSK Investigational Site
Le Fousseret, France, 31430
GSK Investigational Site
Montpellier Cedex 5, France, 34295
GSK Investigational Site
Montreuil Juigne, France, 49460
GSK Investigational Site
Muret, France, 31600
GSK Investigational Site
Nieul sur Mer, France, 17137
GSK Investigational Site
Oignies, France, 62590
GSK Investigational Site
Orthez, France, 64300
GSK Investigational Site
Paris, France, 75679
GSK Investigational Site
Paris Cedex 18, France, 75877
GSK Investigational Site
Rosiers d'Egletons, France, 19300
GSK Investigational Site
Saint Etienne, France, 42100
GSK Investigational Site
Segré, France, 49500
GSK Investigational Site
Seysses, France, 31600
GSK Investigational Site
Tierce, France, 49125
GSK Investigational Site
Tours, France, 37100
GSK Investigational Site
Vourey, France, 38210
Germany
GSK Investigational Site
Gueglingen, Baden-Wuerttemberg, Germany, 74363
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
GSK Investigational Site
Messkirch, Baden-Wuerttemberg, Germany, 88605
GSK Investigational Site
Rudersberg, Baden-Wuerttemberg, Germany, 73635
GSK Investigational Site
Schwetzingen, Baden-Wuerttemberg, Germany, 68723
GSK Investigational Site
Sinsheim, Baden-Wuerttemberg, Germany, 74889
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72074
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
GSK Investigational Site
Augsburg, Bayern, Germany, 86150
GSK Investigational Site
Haag, Bayern, Germany, 83527
GSK Investigational Site
Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
GSK Investigational Site
Kuenzing, Bayern, Germany, 94550
GSK Investigational Site
Muenchen, Bayern, Germany, 80339
GSK Investigational Site
Muenchen, Bayern, Germany, 80636
GSK Investigational Site
Rednitzhembach, Bayern, Germany, 91126
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Cottbus, Brandenburg, Germany, 03050
GSK Investigational Site
Ketzin, Brandenburg, Germany, 14669
GSK Investigational Site
Ruedersdorf, Brandenburg, Germany, 15562
GSK Investigational Site
Bad Kreuznach, Hessen, Germany, 55545
GSK Investigational Site
Floersheim, Hessen, Germany, 65439
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18057
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
GSK Investigational Site
Brinkum/Stuhr, Niedersachsen, Germany, 28816
GSK Investigational Site
Duelmen, Niedersachsen, Germany, 48249
GSK Investigational Site
Koenigslutter, Niedersachsen, Germany, 38154
GSK Investigational Site
Rotenburg (Wuemme), Niedersachsen, Germany, 27356
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44787
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51063
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48155
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58455
GSK Investigational Site
Ingelheim, Rheinland-Pfalz, Germany, 55218
GSK Investigational Site
Kallstadt, Rheinland-Pfalz, Germany, 67169
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
GSK Investigational Site
Koethen, Sachsen-Anhalt, Germany, 06366
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39104
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
GSK Investigational Site
Wolmirstedt, Sachsen-Anhalt, Germany, 39326
GSK Investigational Site
Borna, Sachsen, Germany, 04552
GSK Investigational Site
Delitzsch, Sachsen, Germany, 04509
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Dresden, Sachsen, Germany, 01099
GSK Investigational Site
Dresden, Sachsen, Germany, 01069
GSK Investigational Site
Freiberg, Sachsen, Germany, 09599
GSK Investigational Site
Freital, Sachsen, Germany, 01705
GSK Investigational Site
Geringswalde, Sachsen, Germany, 09326
GSK Investigational Site
Leipzig, Sachsen, Germany, 04315
GSK Investigational Site
Leipzig, Sachsen, Germany, 04207
GSK Investigational Site
Leipzig, Sachsen, Germany, 04103
GSK Investigational Site
Schmiedeberg, Sachsen, Germany, 01762
GSK Investigational Site
Weissenberg, Sachsen, Germany, 02627
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23554
GSK Investigational Site
Erfurt, Thueringen, Germany, 99084
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Berlin, Germany, 10365
GSK Investigational Site
Berlin, Germany, 10777
GSK Investigational Site
Berlin, Germany, 10367
GSK Investigational Site
Berlin, Germany, 13347
GSK Investigational Site
Berlin, Germany, 10717
GSK Investigational Site
Berlin, Germany, 13086
GSK Investigational Site
Berlin, Germany, 12157
GSK Investigational Site
Berlin, Germany, 10435
GSK Investigational Site
Berlin, Germany, 10629
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 12627
GSK Investigational Site
Hamburg, Germany, 20246
GSK Investigational Site
Hamburg, Germany, 20253
GSK Investigational Site
Hamburg, Germany, 22339
GSK Investigational Site
Hamburg, Germany, 22415
GSK Investigational Site
Hamburg, Germany, 22335
GSK Investigational Site
Hamburg, Germany, 22769
GSK Investigational Site
Hamburg, Germany, 22143
Mexico
GSK Investigational Site
Ecatepec de Morelos, Estado de México, Mexico, 55075
GSK Investigational Site
Cuernavaca, Morelos, Mexico
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64610
GSK Investigational Site
Mexico, Mexico, 14000
Netherlands
GSK Investigational Site
Rotterdam, Netherlands, 3011 EN
GSK Investigational Site
Rotterdam, Netherlands, 3001 DC
GSK Investigational Site
Soest, Netherlands, 3762 BN
GSK Investigational Site
Utrecht, Netherlands, 3584 CX
Norway
GSK Investigational Site
Alesund, Norway
GSK Investigational Site
Bekkestua, Norway, N-1357
GSK Investigational Site
Bergen, Norway, 5094
GSK Investigational Site
Elverum, Norway, 2408
GSK Investigational Site
Hamar, Norway, 2317
GSK Investigational Site
Oslo, Norway, 0277
GSK Investigational Site
Oslo, Norway, 0484
GSK Investigational Site
Skien, Norway, 3717
GSK Investigational Site
Stavanger, Norway, 4005
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-021
GSK Investigational Site
Debica, Poland, 39-200
GSK Investigational Site
Grodzisk Mazowiecki, Poland, 05-825
GSK Investigational Site
Ilawa, Poland, 14-200
GSK Investigational Site
Inowrocław, Poland, 88-100
GSK Investigational Site
Katowice, Poland, 40-018
GSK Investigational Site
Krakow, Poland, 31-305
GSK Investigational Site
Krakow, Poland, 31-135
GSK Investigational Site
Krakow, Poland, 30-695
GSK Investigational Site
Lubartow, Poland, 21-100
GSK Investigational Site
Olesnica, Poland, 56-400
GSK Investigational Site
Plock, Poland, 09-400
GSK Investigational Site
Porabka, Poland, 43-353
GSK Investigational Site
Siemianowice Slaskie, Poland, 41-103
GSK Investigational Site
Sopot, Poland, 81-741
GSK Investigational Site
Torun, Poland, 87-100
GSK Investigational Site
Trzebnica, Poland, 55-100
GSK Investigational Site
Tychy, Poland, 43-100
GSK Investigational Site
Wroclaw, Poland, 50-088
Romania
GSK Investigational Site
Braila, Romania, 810019
GSK Investigational Site
Braila, Romania, 810384
GSK Investigational Site
Brasov, Romania, 500366
GSK Investigational Site
Brasov, Romania, 500260
GSK Investigational Site
Brasov, Romania, 500014
GSK Investigational Site
Bucharest, Romania, 077190
GSK Investigational Site
Bucharest, Romania, 020142
GSK Investigational Site
Bucharest, Romania, 010194
GSK Investigational Site
Bucharest, Romania, 062289
GSK Investigational Site
Craiova, Romania, 200128
GSK Investigational Site
Galati, Romania, 800578
GSK Investigational Site
Galati, Romania, 800338
GSK Investigational Site
Pantelimon, Romania, 77145
GSK Investigational Site
Ploiesti, Romania, 100172
Russian Federation
GSK Investigational Site
Barnaul, Russian Federation, 656056
GSK Investigational Site
Ekaterinburg, Russian Federation, 620137
GSK Investigational Site
Ekaterinburg, Russian Federation
GSK Investigational Site
Ekaterinburg, Russian Federation, 620078
GSK Investigational Site
Perm, Russian Federation, 614087
GSK Investigational Site
Perm, Russian Federation, 614010
Taiwan
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taipei, Taiwan, 112
United Kingdom
GSK Investigational Site
Reading, Berkshire, United Kingdom, RG2 0TG
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
GSK Investigational Site
Liverpool, Merseyside, United Kingdom, L22 0LG
GSK Investigational Site
Waterloo, Liverpool, United Kingdom, L22 0LG
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00753272     History of Changes
Other Study ID Numbers: 106372
Study First Received: September 12, 2008
Results First Received: April 26, 2012
Last Updated: September 11, 2014
Health Authority: Estonia: State Agency of Medicines
Czech Republic: Státní ústav pro kontrolu léčiv, Oddělení klinického hodnocení
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Agence Fédérale des Médicaments et des Produits de la Santé
Romania: Agentia Nationala a Medicamentului
Germany: Land Authority for Health and Social Issues
Norway: Statens Legemiddelverk
Taiwan: Department of Health
Russia: Russian Ministry of Health
Poland: URZ.D REJESTRACJI PRODUKTÓW LECZNICZYCH, WYROBÓW MEDYCZNYCH I PRODUKTÓW BIOBÓJCZYCH,CEBK
Canada: Health Canada
Mexico: Ministry of Health
France: Agence Française de Sécurité Sanitaire des Produits de Santé
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by GlaxoSmithKline:
Efficacy
Influenza Vaccines
Influenza
Vaccine
Elderly

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014