Clinical trial NCT00397215: Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Adults Over 60 Years of Age
Official title: Evaluate Immunogenicity & Safety of a Single or Double-dose of the Pandemic Influenza Candidate Vaccine (GSK1562902A) Given Following a Two-administration Schedule (21 Days Apart) in Adults Over 60 Yrs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: H5N1
influenza
vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-08
Enrollment: 437
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the pandemic influenza candidate vaccine (GSK1562902A), administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of influenza antibodies will also be evaluated 24 months after vaccination.

Detailed description: The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the candidate vaccine in healthy elderly persons. The candidate vaccine will be administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of H5N1 influenza antibodies will also be evaluated up to two years after vaccination (neutralizing antibodies will only be evaluated in a subset of subjects in the adjuvanted groups). Single and double dose of H5N1 vaccine non-adjuvanted vaccine will be used as comparator.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female aged 61 years or above at the time of the first vaccination.
* Written informed consent obtained from the subject.
* Healthy subjects or subjects with well controlled underlying disease.

Exclusion Criteria:

* Administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ during the 2006-2007 influenza season.
* Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
* Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of chronic alcohol consumption and/or drug abuse.
* History of hypersensitivity to vaccines.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (including egg and thiomersal allergy).
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Acute disease at the time of enrolment.
* Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first vaccination or during the study.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
* Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Primary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
timeFrame: At Days 0, 21 and 42
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.
timeFrame: At Days 21 and 42
measure: Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
timeFrame: At Days 0, 21 and 42
measure: Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
timeFrame: At Days 0 and 42
measure: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
timeFrame: At Days 21 and 42
measure: Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
timeFrame: At Day 42
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
timeFrame: At Day 180
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
timeFrame: At Month 12
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
timeFrame: At Month 24
measure: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
timeFrame: At Day 180
measure: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
timeFrame: At Month 12
measure: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
timeFrame: At Month 24
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.
timeFrame: At Day 180
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
timeFrame: At Month 12
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
timeFrame: At Month 24
measure: Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
timeFrame: At Day 180
measure: Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
timeFrame: At Month 12
measure: Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
timeFrame: At Month 24
measure: Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
timeFrame: At Day 180
measure: Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
timeFrame: At Month 12
measure: Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
timeFrame: At Month 24
measure: Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
timeFrame: At Month 12
measure: Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
timeFrame: At Month 24
measure: Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
timeFrame: At Day 180
Secondary outcomes:
measure: Number of Subjects With Adverse Events of Specific Interest (AESIs)
timeFrame: During the entire study period (Day 0 to Month 24)
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
timeFrame: During the 7-day follow-up period (Days 0 to 6) after any vaccination
measure: Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.
timeFrame: At Days 0, 2, 21 and 23
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (Day 0 to Month 24).
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
timeFrame: During the 21-day (Days 0-20) follow-up period after first vaccination and during the 30-day (Days 0-29) follow-up period after second vaccination
measure: Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.
timeFrame: At Days 0, 2, 21 and 23.
measure: Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
timeFrame: At Month 12
measure: Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
timeFrame: At Month 24
measure: Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.
timeFrame: At Days 0, 2, 21 and 23.
measure: Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
timeFrame: At Days 0, 21 and 42
measure: Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells
timeFrame: At Day 180
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During the 7-day follow-up period (Days 0 to 6) after any vaccination
Other outcomes:
Locations:
city: Dour
country: Belgium
facility: GSK Investigational Site
city: Gozée
country: Belgium
facility: GSK Investigational Site
city: Libramont
country: Belgium
facility: GSK Investigational Site
city: Mont-Godinne
country: Belgium
facility: GSK Investigational Site
city: Sprimont
country: Belgium
facility: GSK Investigational Site
city: Tessenderlo
country: Belgium
facility: GSK Investigational Site
city: Watermael-Boitsfort
country: Belgium
facility: GSK Investigational Site
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Monserrato Cagliari
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Sassari
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Ragusa
country: Italy
facility: GSK Investigational Site
state: Sicilia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Gillard P, Giet D, Heijmans S, Drame M, Walravens K, Roman F. Long-term outcome of the humoral and cellular immune response of an H5N1 adjuvanted influenza vaccine in elderly persons: 2-year follow-up of a randomised open-label study. Trials. 2014 Oct 29;15:419. doi: 10.1186/1745-6215-15-419.
citation: Heijmans S, De Meulemeester M, Reynders P, Giet D, Demanet E, Devresse PY, Icardi G, Drame M, Roman F, Gillard P. Immunogenicity profile of a 3.75-mug hemagglutinin pandemic rH5N1 split virion AS03A-adjuvanted vaccine in elderly persons: a randomized trial. J Infect Dis. 2011 Apr 15;203(8):1054-62. doi: 10.1093/infdis/jiq174.