Immunization against influenza in male and female subjects aged 60 years and older
Conditions
Interventions
Product Name: GlaxoSmithKline Biologicals low dose influenza vaccine adjuvanted with AS03
Product Code: Flu/AS03
Pharmaceutical Form: Suspension for injection
Other descriptive name: HA from A/New Cal
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 vaccination. •Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visit and completion of the diary cards). •Written informed consent obtained from the subject. •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 (drug or vaccine) 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. (For corticosteroids, this will mean prednisone, or equivalent, > 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • 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 vaccine(s) including egg, chicken protein, gelatine, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate. • 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 diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F)).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To demonstrate the lot-to-lot consistency of 3 lots of the low dose adjuvanted (AS03) influenza vaccine in terms of immunogenicity, 21 days after vaccination. •To assess the safety and reactogenicity in elderly subjects >60 years old vaccinated with low dose adjuvanted (AS03) influenza vaccine and Fluarix, during the entire study period. ;Secondary Objective: •To assess the immunogenicity (GMT, seroconversion factor, seroconversion rate and seroprotection rate) of low dose adjuvanted (AS03) influenza vaccine and Fluarix, given intramuscularly in elderly >60 years old, 21 days following vaccination.;Primary end point(s): • At days 0 and 21: serum haemagglutination-inhibition (HI) antibody titre, against each of the three vaccine influenza virus strains, in a subset of subjects in the low dose adjuvanted (AS03) influenza vaccine groups. • Occurrence of rare events, defined as adverse events with an occurrence rate of 0.1 %, during the entire study period in the low dose adjuvanted (AS03) influenza vaccine groups. • Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms during a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after vaccination in each group. • Occurrence, intensity and relationship to vaccination of unsolicited AEs during a 30 day follow-up period (i.e. day of vaccination and 29 subsequent days) after vaccination in each group. • Occurrence and relationship to vaccination of serious adverse events during the entire study period in each group. • Occurrence of new onset chronic diseases during the entire study period in each group. • Occurrence of medically significant conditions prompting emergency room visits or physician visits that are not related to common diseases or routine visits, during the entire study period in each group. | — |
Countries
Estonia, Germany, Greece, United Kingdom
Outcome results
None listed