Clinical trial NCT00753272: Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older
Official title: Observer-blind Superior Efficacy Trial With GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Efficacy
Influenza Vaccines
Influenza
Vaccine
Elderly
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-09-16
Enrollment: 43695
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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).

Primary outcomes:
measure: 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))
measure: 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:
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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.
Other outcomes:
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city: Segré
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city: Tierce
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city: Tours
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state: Baden-Wuerttemberg
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country: Netherlands
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country: Norway
facility: GSK Investigational Site
city: Stavanger
country: Norway
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Debica
country: Poland
facility: GSK Investigational Site
city: Grodzisk Mazowiecki
country: Poland
facility: GSK Investigational Site
city: Ilawa
country: Poland
facility: GSK Investigational Site
city: Inowrocław
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lubartow
country: Poland
facility: GSK Investigational Site
city: Olesnica
country: Poland
facility: GSK Investigational Site
city: Plock
country: Poland
facility: GSK Investigational Site
city: Porabka
country: Poland
facility: GSK Investigational Site
city: Siemianowice Slaskie
country: Poland
facility: GSK Investigational Site
city: Sopot
country: Poland
facility: GSK Investigational Site
city: Torun
country: Poland
facility: GSK Investigational Site
city: Trzebnica
country: Poland
facility: GSK Investigational Site
city: Tychy
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Braila
country: Romania
facility: GSK Investigational Site
city: Braila
country: Romania
facility: GSK Investigational Site
city: Brasov
country: Romania
facility: GSK Investigational Site
city: Brasov
country: Romania
facility: GSK Investigational Site
city: Brasov
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Craiova
country: Romania
facility: GSK Investigational Site
city: Galati
country: Romania
facility: GSK Investigational Site
city: Galati
country: Romania
facility: GSK Investigational Site
city: Pantelimon
country: Romania
facility: GSK Investigational Site
city: Ploiesti
country: Romania
facility: GSK Investigational Site
city: Barnaul
country: Russian Federation
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Perm
country: Russian Federation
facility: GSK Investigational Site
city: Perm
country: Russian Federation
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Reading
country: United Kingdom
facility: GSK Investigational Site
state: Berkshire
city: Buckshaw Village, Chorley
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
state: Merseyside
city: Waterloo, Liverpool
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: van Essen GA, Beran J, Devaster JM, Durand C, Duval X, Esen M, Falsey AR, Feldman G, Gervais P, Innis BL, Kovac M, Launay O, Leroux-Roels G, McElhaney JE, McNeil S, Oujaa M, Richardus JH, Ruiz-Palacios G, Osborne RH, Oostvogels L. Influenza symptoms and their impact on elderly adults: randomised trial of AS03-adjuvanted or non-adjuvanted inactivated trivalent seasonal influenza vaccines. Influenza Other Respir Viruses. 2014 Jul;8(4):452-62. doi: 10.1111/irv.12245. Epub 2014 Apr 4.
citation: McElhaney JE, Beran J, Devaster JM, Esen M, Launay O, Leroux-Roels G, Ruiz-Palacios GM, van Essen GA, Caplanusi A, Claeys C, Durand C, Duval X, El Idrissi M, Falsey AR, Feldman G, Frey SE, Galtier F, Hwang SJ, Innis BL, Kovac M, Kremsner P, McNeil S, Nowakowski A, Richardus JH, Trofa A, Oostvogels L; Influence65 study group. AS03-adjuvanted versus non-adjuvanted inactivated trivalent influenza vaccine against seasonal influenza in elderly people: a phase 3 randomised trial. Lancet Infect Dis. 2013 Jun;13(6):485-96. doi: 10.1016/S1473-3099(13)70046-X. Epub 2013 Mar 19.