Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years

An Open, Phase IV Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years

The study will evaluate the immune response and the tolerability of the influenza vaccine administered in children aged 6-13 years old.

Inclusion Criteria:

• Healthy children or children with an increased health risk due to an underlying chronic disease-such as chronic airways diseases (including asthma), chronic cardiovascular, hepatic and renal diseases as well as diabetes and other metabolic diseases-aged between 6 and 13 years.
• All subjects must not have received a prior influenza vaccination.
• All subjects must not have had a prior influenza disease.

Exclusion Criteria:

• Use of any study or unlicensed medications/ vaccine other than the study vaccine within 30 days of the vaccination and/or during the study period.
• Acute illness at the start of the study.
• Acute, clinically significant pulmonary, cardiovascular abnormalities or abnormalities of the hepatic or renal function.
• Known allergic reactions which might be caused by the ingredients of the vaccine.
• Girls post-menarche: pregnancy or positive pregnancy-test
• Multiple sclerosis or congenital or acquired immunodeficiencies.