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