Immunization against Influenza in healthy children and children with underlying diseases aged between 6 and 13 years
Conditions
Interventions
Trade Name: Influsplit SSW 2005/2006
Product Name: Trivalent influenza split vaccine
Product Code: FLU
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Purified antigen fractions of
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy children or children with underlying disease aged from 6 to 13 years 2. Only children, which were never vaccinated before or have never experienced a confirmed influenza before, can be enrolled 3. Written informed consent obtained by the parents Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: 4. Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the vaccination, or planned use during the study period 5. Acute disease at the time of enrolment 6. History of allergic disease or reactions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Descriptive analysis of the humoral immune response after one or two dose intramuscular administration of a trivalent influenza split vaccine 2005/2006 in children from 6 years to 9 years measured by the geometric mean titers (GMTs) of the haemagglutination-inhibition antibodies against the three influenza virus strains represented in the vaccine and measured by the seroconversion rate;Secondary Objective: 1.Descriptive analysis of the humoral immune response after one dose intramuscular administration of a trivalent influenza split vaccine 2005/2006 in children from 10 years to 13 years measured by the geometric mean titers (GMTs) of the haemagglutination-inhibition antibodies against the three influenza virus strains represented in the vaccine and measured by the seroconversion rate 2. Descriptive analysis of report, kind and intensity of local and systemic symptoms and serious adverse events occuring over the study period.;Primary end point(s): Descriptive analysis of the humoral immune response after the first dose (Group 1) or the only one dose (Group 2) of the trivalent influenza split vaccine 2005/2006 measured by the geometric mean titers (GMTs) of the haemagglutination-inhibition antibodies and the criteria seroconversion rate, seroconversion factor and protection rate according to the CPMP criteria for adults | — |
Countries
Germany
Outcome results
None listed