The Effectiveness of Varicella Vaccination in Children in Germany

Completed

• Conditions: Chickenpox Vaccines; Varicella (Chickenpox)
• Interventions: Procedure: Varicella (chickenpox) lesion sampling

• Registration Number: NCT00679796
• Lead Sponsor: GlaxoSmithKline

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-05-13
• Study First Submitted QC: 2008-05-16
• Study First Posted: 2008-05-19
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-25
• Last Update Posted: 2012-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1012

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Varicella (chickenpox) lesion sampling	Subjects with PCR confirmed varicella
Group B	Varicella (chickenpox) lesion sampling	Age- and practice-matched control subjects

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 two doses of commercially-available varicella vaccine (≥ 28 days after receipt of the second dose of vaccine) or in unvaccinated children
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 clinical varicella cases in children administered one dose of commercially-available varicella vaccine (≥ 28 days after receipt of vaccine) or in unvaccinated children

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Weilheim, Bayern, Germany