Re-vaccination against influenza in male and female subjects aged 60 years and older.
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A male or female age 60 years or older at the time of the revaccination, who previously received either the low dose adjuvanted (AS03) influenza vaccine or Fluarix during the FLU-LD-002; FLU-LD-006 EXT-002 (D180) clinical trial. Free of an acute aggravation of the health status as established by clinical examination before entering into the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Use of any investigational or non-registered product within 30 days preceding the administration of the study vaccine, or planned use during the study period. •Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. •Administration of other 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 vaccination. •History of hypersensivity to a previous dose of influenza vaccine. •History of confirmed influenza infection within the last 12 months. •History of allergy or reactions likely to be exacerbated by any component of the vaccines. •Acute disease at the time of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess in elderly subjects >=60 years old, the safety and reactogenicity of re-vaccination with the low dose adjuvanted (AS03) influenza vaccine, during the entire study period (30 days). Fluarix will be used as reference.;Secondary Objective: To assess the immunogenicity (GMT, seroconversion factor, seroconversion rate and seroprotection rate) 21 days following re-vaccination with the low dose adjuvanted (AS03) influenza vaccine, given intramuscularly in elderly >=60 years old. Fluarix will be used as reference.;Primary end point(s): •Occurrence, intensity and relationship to re-vaccination of solicited local and general signs and symptoms during a 7-day follow-up period (i.e. day of re-vaccination and 6 subsequent days) after re-vaccination in each group. •Occurrence, intensity and relationship to re-vaccination of unsolicited AEs during a 30-day follow-up period (i.e. day of re-vaccination and 29 subsequent days) after re-vaccination in each group. •Occurrence and relationship to re-vaccination of serious adverse events during the entire study period in each group. | — |
Countries
Norway
Outcome results
None listed