The Effectiveness of Varicella Vaccination in Children in Germany

October 25, 2012 updated by: GlaxoSmithKline
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

1012

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Baldham, Bayern, Germany, 85598
        • GSK Investigational Site
      • Deisenhofen, Bayern, Germany, 82041
        • GSK Investigational Site
      • Freising, Bayern, Germany, 85354
        • GSK Investigational Site
      • Fuerstenfeldbruck, Bayern, Germany, 82256
        • GSK Investigational Site
      • Gilching, Bayern, Germany, 82205
        • GSK Investigational Site
      • Grafing, Bayern, Germany, 85567
        • GSK Investigational Site
      • Grafrath, Bayern, Germany, 82284
        • GSK Investigational Site
      • Kirchheim, Bayern, Germany, 85551
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80339
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81375
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81735
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81377
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80804
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81241
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81737
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80802
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80939
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81925
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81371
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80538
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80796
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81243
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81247
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81249
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81369
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81479
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81543
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81545
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81547
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81669
        • GSK Investigational Site
      • Olching, Bayern, Germany, 82140
        • GSK Investigational Site
      • Taufkirchen, Bayern, Germany, 82024
        • GSK Investigational Site
      • Weilheim, Bayern, Germany, 82362
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All children 12 months of age or older and born on or after 1 July 2003 whose parents contact the pediatrician at the selected sites for suspected varicella after study start. Pediatric practices in Munich and the Munich area will be initially selected.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Subjects with PCR confirmed varicella
Procedure: Varicella (chickenpox) lesion sampling
Group B
Age- and practice-matched control subjects
Procedure: Varicella (chickenpox) lesion sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

Ludwig-Maximilians - University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

May 13, 2008

First Submitted That Met QC Criteria

May 16, 2008

First Posted (ESTIMATE)

May 19, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 29, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109737 (German Cancer Aid)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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