Influenza H1N1 Immunogenicity study - Tilburg Study
- Conditions
- o medical condition.Our aim is to study the immunogenicity against influenza virus H1N1(2009) before and after vaccination
- Registration Number
- EUCTR2009-017138-36-NL
- Lead Sponsor
- St Elisabeth Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
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
none
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).<br><br>To determine the requirement of a second vaccination with Influenza A virus (H1N1) 2009 Monovalent MF59-Adjuvanted Vaccine.<br>;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.
- Secondary Outcome Measures
Name Time Method