Immunisation of healthy male and female subjects aged 18-64 years against influenza
Conditions
Interventions
Product Name: GlaxoSmithKline Biologicals low dose influenza vaccine adjuvanted with AS03 (full dose of AS03)
Product Code: Flu-LD
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Haem
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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. Administration of a vaccine not foreseen by the study protocol up to Visit 3 (day 21). Administration of an influenza vaccine other than the study vaccine up to Visit 4 (day 180).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the immunological non-inferiority (GMT) of the low dose influenza vaccine adjuvanted with AS03 (1/1, 1/2, 1/4, 1/8 dose of AS03) versus Fluarix 21 days following vaccination in all subjects.;Secondary Objective: To assess HI response in terms of anti-haemagglutinin (HI) antibody titres elicited by the low dose influenza vaccine adjuvanted with AS03 (1/1, 1/2, 1/4, 1/8 dose of AS03) and by Fluarix 21 days following vaccination. To assess the persistence of HI antibodies of the low dose influenza vaccine adjuvanted with AS03 (1/1, 1/2, 1/4, 1/8 dose) and by Fluarix 180 days following vaccination. To assess CMI response with AS03 (1/1, 1/2, 1/4, 1/8 dose) and Fluarix in terms of frequency of influenza-specific CD4/CD8 T lymphocytes, at Day 0, 21 and 180 in a subset. To assess HI response in terms of neutralising antibody titres induced by the low dose influenza vaccine adjuvanted with AS03 (1/1, 1/2, 1/4, 1/8 dose) and Fluarix at Day 0, 21 and 180 in a subset. To assess the safety and reactogenicity of the low dose influenza vaccine adjuvanted with AS03 (1/1, 1/2, 1/4, 1/8 dose) and Fluarix during the entire study period.;Primary end point(s): Immunogenicity Observed variable: At days 0 and 21: serum haemagglutination-inhibition (HI) antibody titre, against each of the three vaccine strains, in all subjects. Derived variable: Geometric mean titres (GMTs) of HI antibody titres at days 0 and 21. | — |
Countries
France, Germany, Spain
Outcome results
None listed