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The Effectiveness of Varicella Vaccination in Children in Germany
This study is currently recruiting participants.
Verified by GlaxoSmithKline, September 2009
First Received: May 13, 2008   Last Updated: September 11, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00679796
  Purpose

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.


Condition Intervention
Varicella (Chickenpox)
 Procedure: Varicella (chickenpox) lesion sampling

Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Pediatric Practice-based Case-control Study to Evaluate the Effectiveness of Vaccination Against Laboratory-confirmed Varicella in Young Children in Germany

Resource links provided by NLM:

MedlinePlus related topics: Chickenpox Shingles
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

samples from skin lesions


Estimated Enrollment: 420
Study Start Date: February 2008
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679796

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

Locations
Germany, Bayern
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 81479
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 81543
GSK Investigational Site Recruiting
Fuerstenfeldbruck, Bayern, Germany, 82256
GSK Investigational Site Completed
Muenchen, Bayern, Germany, 81669
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 81377
GSK Investigational Site Recruiting
Freising, Bayern, Germany, 85354
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 80538
GSK Investigational Site Recruiting
Kirchheim, Bayern, Germany, 85551
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 81241
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 81375
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 80939
GSK Investigational Site Recruiting
Taufkirchen, Bayern, Germany, 82024
GSK Investigational Site Recruiting
Grafrath, Bayern, Germany, 82284
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 81925
GSK Investigational Site Recruiting
Weilheim, Bayern, Germany, 82362
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 80796
GSK Investigational Site Recruiting
Baldham, Bayern, Germany, 85598
GSK Investigational Site Not yet recruiting
Gruenwald, Bayern, Germany, 82031
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 81369
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 80339
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 81545
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 80804
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 81737
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 81547
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 81735
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 81243
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 81249
GSK Investigational Site Recruiting
Gilching, Bayern, Germany, 82205
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 81247
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 81371
GSK Investigational Site Recruiting
Olching, Bayern, Germany, 82140
GSK Investigational Site Recruiting
Grafing, Bayern, Germany, 85567
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 80802
GSK Investigational Site Recruiting
Deisenhofen, Bayern, Germany, 82041
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 109737
Study First Received: May 13, 2008
Last Updated: September 11, 2009
ClinicalTrials.gov Identifier: NCT00679796     History of Changes
Health Authority: Germany: Ethics Commission

Keywords provided by GlaxoSmithKline:
case-control,
varicella

Additional relevant MeSH terms:
Virus Diseases
Herpes Zoster
Chickenpox
DNA Virus Infections
Herpesviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010



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