Immunization against influenza in male and female subjects aged 18-40 years old and 65 years and above.
Conditions
Interventions
Product Name: GlaxoSmithKline Biologicals influenza vaccine adjuvanted with AS25 (o/w 250µl + MPL 25µg)
Product Code: FluAS25
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Haemagglu
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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, reporting by phone) should be enrolled in the study. A male or female aged 18-40 years old or 65 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 evaluation (medical history and medical history directed 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) 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) other than the study vaccine(s) within 30 days prior to vaccination, or planned use 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 Visit 3 after vaccination. Planned administration of an influenza vaccine other than the study vaccines during the entire study period. Vaccination against influenza since January 2007 (with 2007/2008 or 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, more than or equal 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 allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate and adjuvant AS25 (containing squalene, alpha-tocopherol, Tween 80 and MPL). Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed 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. Axillary 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. Any medical conditions in which IM injections are contraindicated Lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify an optimal formulation (combination of one o/w emulsion dosage and one MPL dosage) of the adjuvanted influenza vaccine compared to Fluarix, given intramuscularly in subjects aged 65 years old and above, based on immunogenicity (GMT) for the three vaccine strains 21 days following vaccination.;Secondary Objective: To assess the safety and reactogenicity in subjects 65 years old and above vaccinated with the influenza vaccine adjuvanted with various doses of o/w emulsion and MPL and with Fluarix, and in subjects 18-40 years old vaccinated with Fluarix, during the entire study period. To assess the immunogenicity of the influenza vaccine adjuvanted with various doses of o/w emulsion and MPL and of Fluarix, given intramuscularly in subjects 65 years old and above, and of Fluarix given intramuscularly in subjects aged between 18-40 years old, 21 days following vaccination. To evaluate the persistence of HI antibodies 180 days after the first vaccination, in all subjects. To evaluate the CMI response induced by the vaccine adjuvanted with various doses of o/w emulsion and MPL, and by Fluarix in terms of frequency of CD4/CD8 T lymphocytes producing at least two different cytokines (IFN-gamma, IL-2, CD40L, or TNF-alpha), at Days 0, 21 and 180 (for a subset of subjects only). ;Primary end point(s): Immunogenicity Observed variable: At day 21, serum haemagglutination-inhibition (HI) antibody titer, against each of the three vaccine strains, in the 65 years and above groups. Derived variable: Geometric mean titers (GMTs) of HI antibody titers at day 21 | — |
Countries
Germany, Netherlands, Sweden, United Kingdom
Outcome results
None listed