Last updated: 11/07/2018 01:28:12
Trial to evaluate the efficacy of GSK Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Observer-blind superior efficacy trial with GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in elderly subjects
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects reporting polymerase chain reaction (PCR)-confirmed influenza A and/or B infection.
Timeframe: 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.
Timeframe: At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study
Secondary outcomes:
Number of subjects reporting polymerase chain reaction (PCR)-confirmed influenza A and/or B infection.
Timeframe: 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.
Timeframe: 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.
Timeframe: 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.
Timeframe: 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
Timeframe: During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)
Number of subjects reporting any, severe (grade 3) and related to vaccination adverse events (AEs) of specific interest including autoimmune disease (AID).
Timeframe: Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009)
Number of subjects reporting any, severe (grade 3) and related to vaccination adverse events (AEs) of specific interest including autoimmune disease (AID).
Timeframe: Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010)
Number of subjects reporting any, severe (grade 3) and related to vaccination adverse events (AEs) of specific interest including autoimmune disease (AID).
Timeframe: During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)
Number of subjects reporting any and related to vaccination serious adverse events (SAEs).
Timeframe: During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)
Number of subjects reporting any and severe (grade 3) solicited local symptoms.
Timeframe: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
Number of days with any grade of solicited local symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
Number of subjects reporting any and severe (grade 3) solicited local symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Number of days with any grade of solicited local symptoms.
Timeframe: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Number of subjects reporting any, severe (grade 3) and related to vaccination solicited general symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
Number of days with any grade of solicited general symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
Number of subjects reporting any, severe (grade 3) and related solicited general symptoms.
Timeframe: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Number of days with any grade of solicited general symptoms.
Timeframe: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Number of subjects reporting any, severe (grade 3) and related to vaccination unsolicited adverse events (AEs).
Timeframe: Within 21 days (Days 0-20) after the first dose (Year 2008/2009)
Number of subjects reporting any, severe (grade 3) and related to vaccination unsolicited adverse events (AEs).
Timeframe: Within 21 days (Days 0-20) after the second dose (Year 2009/2010)
Number of subjects reporting any, severe (grade 3) and related to vaccination unsolicited AEs with medically attended visit
Timeframe: Within 180 days (Days 0-179) after the first dose (Year 2008/2009)
Number of subjects reporting any, severe (grade 3) and related to vaccination unsolicited AEs with medically attended visit.
Timeframe: Within 180 days (Days 0-179) after the second dose (Year 2009/2010)
Serum hemagglutination-inhibition (HI) antibody titer against each of the 3 vaccine influenza strains.
Timeframe: At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study
Serum hemagglutination-inhibition (HI) antibody titer against each of the 3 vaccine influenza strains
Timeframe: At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study
Serum hemagglutination-inhibition (HI) antibody titer against each of the 3 vaccine influenza strains.
Timeframe: At Days 0 (pre-vaccination Dose 1), 21 (post-vaccination Dose 1) and 180 (post-vaccination Dose 1) of the first year (2008/2009) of the study
Serum hemagglutination-inhibition (HI) antibody titer against each of the 3 vaccine influenza strains.
Timeframe: At Days 0 (pre-vaccination Dose 2), 21 (post-vaccination Dose 2) and 180 (post-vaccination Dose 2) of the second year (2009/2010) of the study
Number of seroconverted subjects for HI antibodies against each of the 3 vaccine influenza strains
Timeframe: At Day 21 of the first year (2008/2009) of the study.
Interventions:
Enrollment:
43695
Primary completion date:
2010-18-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Benoit A et al. (2015) Hemagglutination inhibition antibody titers as a correlate of protection against seasonal A/H3N2 influenza disease. Open Forum Infectious Diseases. 2(2).
Durviaux S et al. (2014) Genetic and antigenic typing of seasonal influenza virus breakthrough cases from a 2008-2009 vaccine efficacy trial. Clin Vaccine Immunol. 21(3):271-279.
McElhaney JE et al. (2013) AS03-Ajuvanted versus non-adjuvanted inactivated trivalent influenza vaccine against seasonal influenza in elderly people: a phase 3 randomised trial. Lancet Infect Dis. 13(6):485-496.
Ruiz-Palacios GM et al. (2016) 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. [Epub ahead of print].
van Essen GA et al. (2014) 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. 8(4):452-462.
Medical condition
Influenza
Product
GSK2186877A, SB218352
Collaborators
Not applicable
Study date(s)
September 2008 to January 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
65+ years
Accepts healthy volunteers
Yes
- 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.
- Bedridden subjects
- Previous vaccination against influenza since February 2008.
Inclusion and exclusion 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).
Trial location(s)
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16506
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51063
Status
Study Complete
Location
GSK Investigational Site
Kallstadt, Rheinland-Pfalz, Germany, 67169
Status
Study Complete
Location
GSK Investigational Site
Hot Springs, Arkansas, United States, 71901
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 03
Status
Study Complete
Location
GSK Investigational Site
Alabaster, Alabama, United States, 35007
Status
Study Complete
Location
GSK Investigational Site
Koenigslutter, Niedersachsen, Germany, 38154
Status
Study Complete
Location
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72074
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
North Myrtle Beach, South Carolina, United States, 29582
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Johnson City, New York, United States, 13790
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Status
Study Complete
Location
GSK Investigational Site
Brinkum/Stuhr, Niedersachsen, Germany, 28816
Status
Study Complete
Location
GSK Investigational Site
Inverness, Florida, United States, 34452
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14621
Status
Study Complete
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
Location
GSK Investigational Site
Gueglingen, Baden-Wuerttemberg, Germany, 74363
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48155
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Status
Study Complete
Location
GSK Investigational Site
Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
Status
Study Complete
Location
GSK Investigational Site
Peoria, Illinois, United States, 61602
Status
Study Complete
Location
GSK Investigational Site
Schwetzingen, Baden-Wuerttemberg, Germany, 68723
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32205
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
Status
Study Complete
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66212
Status
Study Complete
Location
GSK Investigational Site
Jefferson Hills, Pennsylvania, United States, 15025
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85020
Status
Study Complete
Location
GSK Investigational Site
Tabor City, North Carolina, United States, 28463
Status
Study Complete
Location
GSK Investigational Site
Duelmen, Niedersachsen, Germany, 48249
Status
Study Complete
Location
GSK Investigational Site
Camillus, New York, United States, 13031
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Status
Study Complete
Location
GSK Investigational Site
Ingelheim, Rheinland-Pfalz, Germany, 55218
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
Status
Study Complete
Location
GSK Investigational Site
Upper St. Clair, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
Status
Study Complete
Location
GSK Investigational Site
Coquitlam, British Columbia, Canada, V3K 3P4
Status
Study Complete
Location
GSK Investigational Site
Endwell, New York, United States, 13760
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Study Complete
Location
GSK Investigational Site
Waterloo, Liverpool, United Kingdom, L22 0LG
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44787
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85028
Status
Study Complete
Location
GSK Investigational Site
Hackensack, New Jersey, United States, 07601
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
Status
Study Complete
Location
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
Status
Study Complete
Location
GSK Investigational Site
Reading, Berkshire, United Kingdom, RG2 0TG
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29412
Status
Study Complete
Location
GSK Investigational Site
Rudersberg, Baden-Wuerttemberg, Germany, 73635
Status
Study Complete
Location
GSK Investigational Site
Santa Ana, California, United States, 92705
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33761
Status
Study Complete
Location
GSK Investigational Site
Ecatepec de Morelos, Estado de México, Mexico, 55075
Status
Study Complete
Location
GSK Investigational Site
Wolmirstedt, Sachsen-Anhalt, Germany, 39326
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Status
Study Complete
Location
GSK Investigational Site
Crystal River, Florida, United States, 34429
Status
Study Complete
Location
GSK Investigational Site
Huntsville, Alabama, United States, 35802
Status
Study Complete
Location
GSK Investigational Site
Rednitzhembach, Bayern, Germany, 91126
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15205
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Status
Study Complete
Location
GSK Investigational Site
Sinsheim, Baden-Wuerttemberg, Germany, 74889
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
Status
Study Complete
Location
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Status
Study Complete
Location
GSK Investigational Site
Grove City, Pennsylvania, United States, 16127
Status
Study Complete
Location
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Koethen, Sachsen-Anhalt, Germany, 06366
Status
Study Complete
Location
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
Status
Study Complete
Location
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
Status
Study Complete
Location
GSK Investigational Site
Ruedersdorf, Brandenburg, Germany, 15562
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39104
Status
Study Complete
Location
GSK Investigational Site
Cary, North Carolina, United States, 27518
Status
Study Complete
Location
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
Status
Study Complete
Location
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
Status
Study Complete
Location
GSK Investigational Site
Messkirch, Baden-Wuerttemberg, Germany, 88605
Status
Study Complete
Location
GSK Investigational Site
Rotenburg (Wuemme), Niedersachsen, Germany, 27356
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63104
Status
Study Complete
Location
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Status
Study Complete
Location
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58455
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64114
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
Status
Study Complete
Location
GSK Investigational Site
West Jordan, Utah, United States, 84088
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19102
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85050
Status
Study Complete
Location
GSK Investigational Site
Delray Beach, Florida, United States, 33484
Status
Study Complete
Location
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23554
Status
Study Complete
Location
GSK Investigational Site
Liverpool, Merseyside, United Kingdom, L22 0LG
Status
Study Complete
Location
GSK Investigational Site
Uniontown, Pennsylvania, United States, 15401
Status
Study Complete
Location
GSK Investigational Site
Hickory, North Carolina, United States, 28601
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2010-18-06
Actual study completion date
2011-05-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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