The Effectiveness of Varicella Vaccination in Children in Germany

Study Overview
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Brief Summary
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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.

Detailed Description
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Observational, multicenter, population-based, matched case-control study conducted in selected pediatric practices in the Munich area.

Official Title
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The Effectiveness of Varicella Vaccination in Children in Germany

Conditions
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Varicella (Chickenpox), Chickenpox Vaccines

Intervention / Treatment
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* Procedure: Varicella (chickenpox) lesion sampling


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Subjects with PCR confirmed varicella | Procedure: Varicella (chickenpox) lesion sampling<br> <br> |
| Group B<br>Age- and practice-matched control subjects | Procedure: Varicella (chickenpox) lesion sampling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varicella, case-control