Open study to determine the immunogenicity and reactogenicity of Influsplit SSW 2005/2006 in children from 6 years until 13 years of age - Flu-062
- Conditions
- Immunization against Influenza in healthy children and children with underlying diseases aged between 6 and 13 years
- Registration Number
- EUCTR2005-004517-14-DE
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method