Immunization against influenza of healthy adults MedDRA version: 9.1 Level: LLT Classification code 10016794 Term: Flu vaccination
Conditions
Interventions
Trade Name: Fluarix / Influsplit SSW /Alpha-Rix
Product Name: Trivalent influenza split vaccine
Product Code: FLU
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Purified antigen fr
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy the following criteria at study entry: •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 aged 18 years or above at the time of the vaccination. •Written informed consent obtained from the subject. •Healthy subjects or with well-controlled 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, 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 the duration of the study 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. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) •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 1 year preceding the study start. •Administration of an influenza vaccine other than the study vaccine during the entire study •Clinically or virologically confirmed influenza infection within 1 year 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 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 / Axillary temperature <37.5°C) •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-hemagglutinin antibody tested by hemagglutination inhibition) against each vaccine strain in adults aged 18 years or above 21 days after vaccination with Fluarix™/Influsplit SSW® 2007/2008;Secondary Objective: To evaluate the safety/reactogenicity of Fluarix™/Influsplit SSW® 2007/2008 in adults aged 18 years or above, in terms of: •solicited local/general symptoms during 4 days post-vaccination (Day 0-Day 3) •unsolicited symptoms during 21 days post-vaccination (Day 0-Day 20) •serious adverse events during 21 days post-vaccination (Day 0-Day 20) ;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 (SCR)* at Day 21 •Seroconversion Factors (SCF)** at Day 21 •Seroprotection Rates (SPR)*** at Days 0 and 21 •Seroprotection Power (SPP)**** at Day 21 * Seroconversion Rate (SCR) is defined as the percentage of vaccinees who have either a prevaccination titer < 1:10 and a post-vaccination titer ? 1:40 or a pre-vaccination titer ? 1:10 and at least a fourfold increase in post-vaccination titer **Seroconversion Factor (SCF) is defined as the fold increase in serum HI GMTs post-vaccination compared to day 0. ***Seroprotection Rate (SPR) is defined as the percentage of vaccinees with a serum HI titer ?1:40 that usually is accepted as indicating protection. ****Seroprotection Power (SPP) is defined as the percentage of subjects who have a prevaccination titer <1:40 and a post-vaccination titer ? 1:40 | — |
Countries
Germany
Outcome results
None listed