immunization against influenza of healthy adults
Conditions
Interventions
Trade Name: Influsplit SSW (in Germany), Fluarix or alpha-Rix (in Belgium
Product Name: Trivalent influenza split vaccine
Product Code: FLU
Pharmaceutical Form: Suspension for injection
INN or Propose
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 should be enrolled in the study. • A male or female aged 18 years or above at the time of the vaccination. • Written informed consent obtained from the subject. • Healthy subjects or with well-stabilized chronic diseases 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 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 preceding the vaccination or planned use during the study period. • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study. • Administration of an influenza vaccine within 6 months preceding the study start • Administration of an influenza vaccine other than the study vaccine during the entire study • Confirmed influenza infection within 6 months preceding the study start • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. • Acute disease at the time of enrolment. • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. • Not stabilized or clinically serious chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insuline-dependent diabetes Mellitus) • Lactating female. • History of chronic alcohol consumption and/or drug abuse. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the humoral response (anti-haemagglutinin antibody tested by haemagglutination inhibition) against each vaccine strain in adults aged 18 years or above 21 days after vaccination with Fluarix™/Influspit SSW® 2006/2007.;Secondary Objective: To evaluate the safety/reactogenicity of Fluarix™/Influspit SSW® 2006/2007 in adults aged 18 years or above, in terms of: • solicited local/general symptoms during 4 days post-vaccination • unsolicited symptoms during 30 days post-vaccination • serious adverse events during 30 days post-vaccination ;Primary end point(s): Evaluation of the humoral immune response in terms of anti-HA antibodies against each of the three vaccine influenza strains: the following parameters will be calculated with 95% confidence intervals: • Geometric mean titers (GMTs) of anti-HA antibody titers at days 0 and 21 • Seroconversion rates* at day 21 • Seroconversion factors** at day 21 • Seroprotection rates*** at days 0 and 21 • Seroprotection power**** at day 21 | — |
Countries
Germany
Outcome results
None listed