Chickenpox Vaccines, Varicella (Chickenpox)
Conditions
Keywords
varicella, case-control
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 immunization calendar.
Detailed description
Observational, multicenter, population-based, matched case-control study conducted in selected pediatric practices in the Munich area.
Interventions
PROCEDUREVaricella (chickenpox) lesion sampling
Sponsors
Ludwig-Maximilians - University of Munich
GlaxoSmithKline
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | 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
| Measure | 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 | — |
Countries
Germany
Outcome results
None listed