Immunization of healthy adults aged 18 to 60 years against influenza
Conditions
Interventions
Product Name: GlaxoSmithKline Biologicals trivalent influenza vaccine
Product Code: Flu TIV
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Haemagglutinin from A/Solomon Islands/3/2
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Healthy subjects as established by medical history and clinical examination before entering into the study. •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) should be enrolled in the study. •A male or female between, and including, 18 and 60 years of age at the time of the vaccination. •Written informed consent obtained from the subject. •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 administration 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 administration of the vaccine. (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 post vaccination. •Confirmed influenza infection within a year preceding the study start. •Administration of an influenza vaccine during Northern Hemisphere season 2007-2008. •Concurrently participating 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). •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). •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. Oral temperature <37.5°C. •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. •Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period. •Pregnant or lactating female. •Female planning to become pregnant or planning to discontinue contraceptive precautions. •History of chronic alcohol consumption and/or drug abuse. •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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To assess the immunological non- inferiority (GMT) of the quadrivalent influenza study vaccine over the trivalent influenza vaccine for the three recommended interpandemic strains. •To assess the immunological non- inferiority (GMT) of the adjuvanted low dose quadrivalent influenza study vaccine over the adjuvanted low dose trivalent influenza vaccine for the three recommended interpandemic strains. •To assess the immunological superiority (GMT) of the quadrivalent influenza study vaccine over the trivalent influenza vaccine in terms of B/Jiangsu/10/2003 strain that is not included in the trivalent influenza vaccine. •To assess the immunological superiority (GMT) of the adjuvanted low dose quadrivalent influenza study vaccine over the adjuvanted low dose trivalent influenza study vaccine in terms of B/Jiangsu/10/2003 strain that is not included in the low dose adjuvanted trivalent influenza vaccine. ;Secondary Objective: •To assess the immunological non-inferiority (GMT) of the low dose adjuvanted quadrivalent influenza study vaccine over the non-adjuvanted quadrivalent study vaccine. •To assess the humoral immune response (anti-haemagglutinin antibody titres) induced by the study vaccines 21 days after vaccination. •To assess the safety and reactogenicity of the study vaccines during the entire study period (follow-up of solicited symptoms during 7 days, follow-up of unsolicited symptoms during 21 days, follow-up of serious adverse events, Medically Significant Conditions (MSCs) and adverse events of specific interest including autoimmune diseases (AID) throughout the entire study period. ;Primary end point(s): Observed variables •At Days 0 and 21 serum haemagglutination-inhibition (HI) antibody titre, against each of the vaccine influenza virus strains, in each group. Derived variables •Geometric mean titers (GMTs) of HI antibody titers at Days 0 and 21 | — |
Countries
Czech Republic
Outcome results
None listed