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| Name | Class |
|---|---|
| Ludwig-Maximilians - University of Munich | OTHER |
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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.
Observational, multicenter, population-based, matched case-control study conducted in selected pediatric practices in the Munich area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Subjects with PCR confirmed varicella |
| |
| Group B | Age- and practice-matched control subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varicella (chickenpox) lesion sampling | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of PCR-confirmed varicella cases in children administered one dose of Varilrix™ (≥ 28 days after receipt of vaccine) or in unvaccinated children. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Ineligible for varicella vaccination, due to any medical contraindication. These contraindications are:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Baldham | Bavaria | 85598 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| Background | 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. | ||
| 23694831 | Derived | Liese JG, Cohen C, Rack A, Pirzer K, Eber S, Blum M, Greenberg M, Streng A. The effectiveness of varicella vaccination in children in Germany: a case-control study. Pediatr Infect Dis J. 2013 Sep;32(9):998-1004. doi: 10.1097/INF.0b013e31829ae263. |
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samples from skin lesions
| 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 |
| Deisenhofen |
| Bavaria |
| 82041 |
| Germany |
| GSK Investigational Site | Freising | Bavaria | 85354 | Germany |
| GSK Investigational Site | Fürstenfeldbruck | Bavaria | 82256 | Germany |
| GSK Investigational Site | Gilching | Bavaria | 82205 | Germany |
| GSK Investigational Site | Grafing | Bavaria | 85567 | Germany |
| GSK Investigational Site | Grafrath | Bavaria | 82284 | Germany |
| GSK Investigational Site | Kirchheim | Bavaria | 85551 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80339 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80538 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80796 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80802 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80804 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80939 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81241 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81243 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81247 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81249 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81369 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81371 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81375 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81377 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81479 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81543 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81545 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81547 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81669 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81735 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81737 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81925 | Germany |
| GSK Investigational Site | Olching | Bavaria | 82140 | Germany |
| GSK Investigational Site | Taufkirchen | Bavaria | 82024 | Germany |
| GSK Investigational Site | Weilheim | Bavaria | 82362 | Germany |
| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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