No medical condition. Our aim is to study the immunogenicity against influenza virus H1N1(2009) before and after vaccination
Conditions
Interventions
Product Name: Focetria
Product Code: Focetria-H-C-710-PU-05
Pharmaceutical Form: Suspension for injection
Sponsors
St Elisabeth Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All the subjects are between 18 and 65 years of age 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the humoral and cellular immunity before and after vaccination with the Influenza A (H1N1) 2009 Monovalent MF59-Adjuvanted Vaccine.;Secondary Objective: To study the impact of earlier seasonal vaccination on the immune response against the influenza virus H1N1 (2009). To determine the requirement of a second vaccination with Influenza A virus (H1N1) 2009 Monovalent MF59-Adjuvanted Vaccine. ;Primary end point(s): The study parameters for humoral immune response are hemagglutination-inhibition antibodies titers. Sera will be analyzed by a hemagglutination-inhibition (HAI) test, according to standard procedures. | — |
Countries
Netherlands
Outcome results
None listed