Immunization against Influenza in healthy male and female subjects aged over 18 years
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:
INN or Proposed INN: Purified antigen
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A male or female aged 18 years of age at the time of the vaccination, not vaccinated against influenza in the previous season. 2. Written informed consent obtained from the subject. 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: 3. Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period. 4. 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/axillary temperature < 37.5°C. 5. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. 6. Pregnant female. 7. Female who is willing to become pregnant during the period starting the day of vaccination and ending one month after vaccination. 8. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Descriptive analysis of the humoral immune response after intramuscular administration of a trivalent influenza split vaccine 2005/2006 in persons aged over 18 years (in two parallel groups 18 – 60 years and over 60 years) measured by the geometric mean titers (GMTs) of the haemagglutination-inhibition antibodies against the three influenza virus strains represented in the vaccine on day 21 (± 2) after vaccination. 2. Descriptive analysis of the reactogenicity after intramuscular administration of the trivalent influenza split vaccine 2005/2006 in persons aged over 18 years (in two parallel groups 18 – 60 years and over 60 years), measured on the solicited local symptoms PAIN, REDNESS, INDURATION and solicited general symptoms FEVER, SHIVERING, FATIGUE, HEADACHE, SWEATING, MYALGIA and ARTHRALGIA according to the criteria of the CPMP, overall incidence and occurrence of symptoms (separate analysis for symptoms graded 1?3 and 2?3 respectively). ;Secondary Objective: 1. Descriptive analysis of the humoral immune response after intramuscular administration of the trivalent influenza split vaccine 2005/2006 in persons aged over 18 years (in two parallel groups 18 – 60 years and over 60 years) measured by seroconversion rate or significant increase of the haemagglutination-inhibition antibodies and seroprotection rate against the three influenza virus strains represented in the vaccine on day 21 (± 2) after vaccination and to consider if the parameter is in correlation to the criteria of CPMP. 2. Serious adverse events for the vaccine occurring the study period will be recorded. ;Primary end point(s): 1. Descriptive analysis of the humoral immune response after intramuscular administration of the new trivalent influenza split vaccine 2004/2005 in persons aged over 18 years (in two parallel groups 18 – 60 years and over 60 years) measured by the geometric mean titers (GMTs) of the haemagglutination-inhibition antibodies against the three influenza virus | — |
Countries
Germany
Outcome results
None listed