Last updated: 11/03/2018 10:36:04
The effectiveness of varicella vaccination in children in Germany
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: The effectiveness of varicella vaccination in children in Germany
Trial description: 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 immunization calendar.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
1012
Primary completion date:
2010-14-10
Observational study model:
Case-Control
Time perspective:
Prospective
Clinical publications:
Liese J et al. Effectiveness of one dose of varicella vaccine after introduction of routine varicella vaccination in Germany. Abstract presented at the 20th Congress of German Society for pediatric infectious diseases (GSPID). e.V.Mannheim, Germany, 19-21 April 2012.
Liese J et al. Pediatric practice-based case-control study to evaluate the effectiveness of vaccination against laboratory-confirmed varicella in young children in Germany. Abstract presented at the 30th Annual Meeting of the European Society for Pediatric Infectious Diseases (ESPID) meeting, Thessaloniki, Greece 8-12 May 2012.
Liese JG et al. (2013) The effectiveness of varicella vaccination in children in Germany: a case-control study. Pediatr Infect Dis J. [Epub ahead of print]
Medical condition
Varicella (chickenpox)
Product
SB208133, SB208136
Collaborators
University of Munich
Study date(s)
February 2008 to October 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
1+ years
Accepts healthy volunteers
Yes
- Male or female child at least one year of age, born on or after July 1 2003.
- Residence in Germany
- Ineligible for varicella vaccination, due to any medical contraindication. These contraindications are:
- * History of hypersensitivity to any of the components of the vaccines
Inclusion and exclusion criteria
Inclusion criteria:
- 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 criteria:
- 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).
Trial location(s)
Location
GSK Investigational Site
Fuerstenfeldbruck, Bayern, Germany, 82256
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2010-14-10
Actual study completion date
2010-14-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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