Healthy subjects, Immunization against influenza in male and female subjects aged = 50 years.
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). • A male or female aged between 18 and 40 years or aged 50 years or older at the time of the vaccination. • 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. •If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: • 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. • Planned administration of an influenza vaccine other than the study vaccines during the entire study period. •Previous vaccination against influenza (2006-2007 influenza vaccine). •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. (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). •History of hypersensivity to a previous dose of influenza vaccine. •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, gelatin, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate. •Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests. •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)). •Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration 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 vaccination, or planned use during the study period. •Any medical conditions in which IM injections are contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To demonstrate that the immune response induced by FluAS25 in elderly adults is superior to that induced by Fluarix, 21 days following vaccination for each vaccine strain. •To demonstrate that the immune response induced by the FluAS25 in subjects aged between 50 and 64 years is superior to the one induced by Fluarix, 21 days following vaccination for each vaccine strain. ;Secondary Objective: •To evaluate in all subjects, the safety and reactogenicity of one dose of FluAS25 and Fluarix •To demonstrate that the immune response induced by the FluAS25 in elderly adults is non-inferior to the one induced by Fluarix in young adults, 21 days following vaccination for at least 2 of the 3 vaccine strains. •To evaluate the immunogenicity of FluAS25 and Fluarix, 21 and 180 days following vaccination, in all subjects. •To demonstrate, in a subset of subjects aged = 65 years and in subjects aged 50-64 years, that the CMI response in terms of frequency of influenza-specific CD4 T lymphocytes producing at least two different cytokines induced by the FluAS25 is superior to the one induced by Fluarix, 21 days following vaccination. •To evaluate in a subset of subjects, the CMI response induced by the study vaccines in terms of frequency of influenza-specific CD4 T lymphocytes at Day 0, 21 and 180. ;Primary end point(s): Observed variable • At days 0 and 21, serum haemagglutination-inhibition (HI) antibody titer, against each of the three vaccine strains, in the following age groups: 50-64 years and >/= 65 years Derived variables: - Geometric mean titers (GMTs) of HI antibody titers at days 0 and 21 - Seroconversion rates at day 21 defined as the percentage of vaccinees who have either a prevaccination titer /= 1:40 or a pre-vaccination titer >/= 1:10 and at least a four-fold increase in post-vaccination titer. | — |
Countries
Germany, Norway
Outcome results
None listed