Status:
COMPLETED
Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
6-13 years
Phase:
PHASE4
Brief Summary
The study will evaluate the immune response and the tolerability of the influenza vaccine administered in children aged 6-13 years old.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 17 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2006
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00372255
Start Date
November 17 2005
End Date
March 28 2006
Last Update
May 6 2019
Active Locations (18)
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1
GSK Investigational Site
Würzburg, Bavaria, Germany, 97070
2
GSK Investigational Site
Bützow, Mecklenburg-Vorpommern, Germany, 18246
3
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18106
4
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18109