Estudio fase II, controlado, aleatorizado, multicéntrico, simple ciego para evaluar la inmunogenicidad, seguridad y reactogenicidad de la vacuna de gripe de dosis reducida con diferentes dosis del adjuvante AS03 comparada con Fluarix (GlaxoSmithkline Biologicals) administrada de forma intramuscular en sujetos entre 18 y 64 años de edad.A phase II, controlled, randomized, multicentre, single blind study to evaluate the immunogenicity, safety and reactogenicity of the low dose influenza vaccine with various doses of the AS03 adjuvant compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in subjects aged 18-64 years. - FLU-LD-012
- Conditions
- Immunisation of healthy male and female subjects aged 18-64 years against influenza.Inmunización frente a la gripe en sujetos sanos entre 18 y 64 años de edad
- Registration Number
- EUCTR2007-003776-18-ES
- Lead Sponsor
- GlaxoSmithKline S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
Only subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
A male or female between, and including, 18 - 64 years of age at the time of vaccination.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
If the subject is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
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) no
F.1.3.1 Number of subjects for this age range
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.
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.)
Administration of a vaccine not foreseen by the study protocol from 30 days before vaccination, up to 21 days after vaccination.
History of hypersensitivity to a previous dose of influenza vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, formaldehyde, thiomersal, gentamicin sulphate or any component of the adjuvant AS03 (containing squalene, alpha-tocopherol and Tween 80).
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Confirmed influenza infection within a year preceding the study start.
Administration of an influenza vaccine within a year preceding the study start.
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.
Pregnant or lactating female.
Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
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. Axillary temperature <37.5°C (99.5°F))
History of chronic alcohol consumption and/or drug abuse.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
History of administration of experimental/licensed vaccine containing squalene and/or tocopherol within the last 12 months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method