The Effectiveness of Varicella Vaccination in Children in Germany
This study has been completed.
Sponsor:
GlaxoSmithKline
Collaborator:
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00679796
First received: May 13, 2008
Last updated: October 25, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Varicella (Chickenpox) Chickenpox Vaccines |
Procedure: Varicella (chickenpox) lesion sampling |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | The Effectiveness of Varicella Vaccination in Children in Germany |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of PCR-confirmed varicella cases in children administered one dose of Varilrix™ (≥ 28 days after receipt of vaccine) or in unvaccinated children.
Secondary Outcome Measures:
- Occurrence of PCR-confirmed varicella cases in children administered one dose of commercially-available varicella vaccine (≥ 28 days after receipt of vaccine) or in unvaccinated children
- Occurrence of PCR-confirmed severe varicella cases in children administered one dose of Varilrix™ (≥ 28 days after receipt of vaccine) or in unvaccinated children
- Occurrence of PCR-confirmed severe varicella cases in children administered one dose of commercially-available varicella vaccine (≥ 28 days after receipt of vaccine) or in unvaccinated children
- Occurrence of clinical varicella cases in children administered one dose of commercially-available varicella vaccine (≥ 28 days after receipt of vaccine) or in unvaccinated children
- Occurrence of clinical varicella cases in children administered two doses of commercially-available varicella vaccine (≥ 28 days after receipt of the second dose of vaccine) or in unvaccinated children
Biospecimen Retention: Samples With DNA
samples from skin lesions
| Enrollment: | 1012 |
| Study Start Date: | February 2008 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Group A
Subjects with PCR confirmed varicella
|
Procedure: Varicella (chickenpox) lesion sampling
Other Name: Varicella (chickenpox) lesion sampling
|
|
Group B
Age- and practice-matched control subjects
|
Procedure: Varicella (chickenpox) lesion sampling
Other Name: Varicella (chickenpox) lesion sampling
|
Detailed Description:
Observational, multicenter, population-based, matched case-control study conducted in selected pediatric practices in the Munich area.
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
All children 12 months of age or older and born on or after 1 July 2003 whose parents contact the pediatrician at the selected sites for suspected varicella after study start. Pediatric practices in Munich and the Munich area will be initially selected.
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679796
Locations
| Germany | |
| GSK Investigational Site | |
| Baldham, Bayern, Germany, 85598 | |
| GSK Investigational Site | |
| Deisenhofen, Bayern, Germany, 82041 | |
| GSK Investigational Site | |
| Freising, Bayern, Germany, 85354 | |
| GSK Investigational Site | |
| Fuerstenfeldbruck, Bayern, Germany, 82256 | |
| GSK Investigational Site | |
| Gilching, Bayern, Germany, 82205 | |
| GSK Investigational Site | |
| Grafing, Bayern, Germany, 85567 | |
| GSK Investigational Site | |
| Grafrath, Bayern, Germany, 82284 | |
| GSK Investigational Site | |
| Kirchheim, Bayern, Germany, 85551 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 80804 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81377 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81249 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81543 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81925 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 80939 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81371 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 80339 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 80538 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81375 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 80802 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81241 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81737 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81669 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81369 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81479 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81243 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 80796 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81247 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81547 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81545 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81735 | |
| GSK Investigational Site | |
| Olching, Bayern, Germany, 82140 | |
| GSK Investigational Site | |
| Taufkirchen, Bayern, Germany, 82024 | |
| GSK Investigational Site | |
| Weilheim, Bayern, Germany, 82362 | |
Sponsors and Collaborators
GlaxoSmithKline
Ludwig-Maximilians - University of Munich
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00679796 History of Changes |
| Other Study ID Numbers: | 109737 |
| Study First Received: | May 13, 2008 |
| Last Updated: | October 25, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by GlaxoSmithKline:
|
varicella case-control |
Additional relevant MeSH terms:
|
Chickenpox Herpes Zoster Herpesviridae Infections DNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 21, 2013