Clinical Trial: The Effectiveness of Varicella Vaccination in Children in Germany

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: The Effectiveness of Varicella Vaccination in Children in Germany

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

Current Primary Outcome: Occurrence of PCR-confirmed varicella cases in children administered one dose of Varilrix™ (≥ 28 days after receipt of vaccine) or in unvaccinated children.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: May 13, 2008
Date Started: February 2008
Date Completion:
Last Updated: October 25, 2012
Last Verified: October 2012