Immunization against influenza of healthy adults MedDRA version: 12.1 Level: LLT Classification code 10022000 Term: Influenza
Conditions
Interventions
Trade Name: Fluarix/Influsplit SSW/alpha-Rix
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: A/California/7/2009 NYMC X-181
Concentration unit: µg/ml microgram(s)/millilitre
Concent
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) 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 (see glossary) 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 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 vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, = 20 mg/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 6 months 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 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 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) . • 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® 2010-2011 ;Secondary Objective: To evaluate to safety/reactogenicity of Fluarix™/influsplit SSW® 2010-2011 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 (SAEs) during 21 days post-vaccination (Day 0 - Day 20) ;Primary end point(s): Observed variable: • Evaluation of the humoral immune response in terms of anti-HA antibodies against each of the three vaccine influenza strains Derived variables: • The following parameters will be calculated with 95% confidence intervals: At Days 0 and 21 • Geometric mean titers (GMTs) of anti-HA antibody titers. • Seroprotection rates (SPR-defined as percentage of vaccines with serum HI titer = 1:40 usually accepted as indicating protection). At Day 21 • Seroconversion rates (SCR-defined as the percentage of vaccinees with either a prevaccination titer < 1:10 and a post-vaccination titer = 1:40 or a pre-vaccination titer = 1:10 and at least 4-fold increase in post-vaccination titer). • Seroconversion factors (SCF-defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0). • Seroprotection power (SPP-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