Status:
COMPLETED
The Effectiveness of Varicella Vaccination in Children in Germany
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Ludwig-Maximilians - University of Munich
Conditions:
Varicella (Chickenpox)
Chickenpox Vaccines
Eligibility:
All Genders
1+ years
Brief Summary
This study is undertaken to evaluate the effectiveness of currently licensed varicella vaccines under conditions of routine use in a setting where varicella vaccine is included in the childhood immuni...
Detailed Description
Observational, multicenter, population-based, matched case-control study conducted in selected pediatric practices in the Munich area.
Eligibility Criteria
Inclusion
- Male or female child at least one year of age, born on or after July 1 2003.
- Residence in Germany
- At least one previous well-child visit to the practice
- Written informed consent obtained from parents/guardians of the subject as per local requirements.
- Specific inclusion criterion for cases:
- Suspected primary varicella disease (i.e. chickenpox) at the time of study entry
Exclusion
- Ineligible for varicella vaccination, due to any medical contraindication. These contraindications are:
- History of hypersensitivity to any of the components of the vaccines
- Congenital or acquired immunodeficiency
- Treatment with immunosuppressive therapy
- HIV-infected patients, when CD4 \< 25% of total lymphocytes
- Previous history of chickenpox by physician record or parental report.
- Lack of documented vaccination history (written or computerised practice records or child's vaccination card/booklet).
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
1012 Patients enrolled
Trial Details
Trial ID
NCT00679796
Start Date
February 1 2008
End Date
October 1 2010
Last Update
October 29 2012
Active Locations (33)
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1
GSK Investigational Site
Baldham, Bavaria, Germany, 85598
2
GSK Investigational Site
Deisenhofen, Bavaria, Germany, 82041
3
GSK Investigational Site
Freising, Bavaria, Germany, 85354
4
GSK Investigational Site
Fürstenfeldbruck, Bavaria, Germany, 82256