The Effectiveness of Varicella Vaccination in Children in Germany - Full Text View

Sponsored by:	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

MedlinePlus related topics: Chickenpox Shingles

U.S. FDA Resources

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

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, 81543
GSK Investigational Site	Active, not recruiting
Freising, Bayern, Germany, 85354
GSK Investigational Site	Active, not recruiting
Muenchen, Bayern, Germany, 81247
GSK Investigational Site	Active, not recruiting
Muenchen, Bayern, Germany, 81479
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	Active, not recruiting
Grafing, Bayern, Germany, 85567
GSK Investigational Site	Not yet recruiting
Neufahrn, Bayern, Germany, 85375
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	Withdrawn
Muenchen, Bayern, Germany, 80337
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	Withdrawn
Puchheim, Bayern, Germany, 82178
GSK Investigational Site	Recruiting
Grafrath, Bayern, Germany, 82284
GSK Investigational Site	Recruiting
Muenchen, Bayern, Germany, 81925
GSK Investigational Site	Recruiting
Muenchen, Bayern, Germany, 81249
GSK Investigational Site	Recruiting
Muenchen, Bayern, Germany, 80796
GSK Investigational Site	Recruiting
Baldham, Bayern, Germany, 85598
GSK Investigational Site	Recruiting
Gilching, Bayern, Germany, 82205
GSK Investigational Site	Withdrawn
Muenchen, Bayern, Germany, 81373
GSK Investigational Site	Withdrawn
Muenchen, Bayern, Germany, 81675
GSK Investigational Site	Withdrawn
Muenchen, Bayern, Germany, 81673
GSK Investigational Site	Recruiting
Deisenhofen, Bayern, Germany, 82041
GSK Investigational Site	Withdrawn
Muenchen, Bayern, Germany, 80807
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	Withdrawn
Muenchen, Bayern, Germany, 81737
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	Active, not recruiting
Muenchen, Bayern, Germany, 81675
GSK Investigational Site	Recruiting
Weilheim, Bayern, Germany, 82362

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	109737
Study First Received:	May 13, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00679796
Health Authority:	Germany: Ethics Commission

Keywords provided by GlaxoSmithKline:

case-control,
varicella

Study placed in the following topic categories:

Virus Diseases
Herpes Zoster
Chickenpox

DNA Virus Infections
Chicken pox
Herpesviridae Infections

ClinicalTrials.gov processed this record on January 14, 2009