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

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GSK study ID
106372
See study documents
Clinicaltrials.gov ID
NCT00753272
See results summary
EudraCT ID
2008-000872-25
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
  • Biological/vaccine: GSK Bio's influenza vaccine GSK2186877A
  • Biological/vaccine: Fluarix TM
    • 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
    Status
    Contact us
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    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 20253
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Erie, Pennsylvania, United States, 16506
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Koeln, Nordrhein-Westfalen, Germany, 51063
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Inowrocław, Poland, 88-100
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Quebec, Québec, Canada, G1W 4R4
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kallstadt, Rheinland-Pfalz, Germany, 67169
    Status
    Study Complete
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    Showing 1 - 6 of 268 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    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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