Skip to main content
OpenTrials
Completed

NCT Number: NCT00679796

The Effectiveness of Varicella Vaccination in Children in Germany

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Varicella (Chickenpox) Chickenpox Chickenpox Vaccines DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Baldham, Bavaria, Germany

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Varicella (chickenpox) lesion sampling

Procedure

Primary outcomes

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

Secondary outcomes

  1. 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

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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • Ludwig-Maximilians - University of Munich

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 19, 2008
Registry last updated
Oct 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.