The Effectiveness of Varicella Vaccination in Children in Germany

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Varicella (Chickenpox)

Chickenpox Vaccines

Treatments

Procedure: Varicella (chickenpox) lesion sampling

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT00679796

109737

Details and patient eligibility

About

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.

Full description

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

Enrollment

1,012 patients

Sex

All

Ages

1+ year old

Volunteers

Accepts Healthy Volunteers

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).