The Effectiveness of Varicella Vaccination in Children in Germany

NCT ID: NCT00679796

Last Updated: 2012-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1012 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-10-31

Brief Summary

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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 Description

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

Conditions

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Varicella (Chickenpox) Chickenpox Vaccines

Keywords

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varicella case-control

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Subjects with PCR confirmed varicella

Varicella (chickenpox) lesion sampling

Intervention Type PROCEDURE

Group B

Age- and practice-matched control subjects

Varicella (chickenpox) lesion sampling

Intervention Type PROCEDURE

Interventions

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Varicella (chickenpox) lesion sampling

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Baldham, Bavaria, Germany

Site Status

GSK Investigational Site

Deisenhofen, Bavaria, Germany

Site Status

GSK Investigational Site

Freising, Bavaria, Germany

Site Status

GSK Investigational Site

Fürstenfeldbruck, Bavaria, Germany

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GSK Investigational Site

Gilching, Bavaria, Germany

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GSK Investigational Site

Grafing, Bavaria, Germany

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GSK Investigational Site

Grafrath, Bavaria, Germany

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GSK Investigational Site

Kirchheim, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Olching, Bavaria, Germany

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GSK Investigational Site

Taufkirchen, Bavaria, Germany

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GSK Investigational Site

Weilheim, Bavaria, Germany

Site Status

Countries

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Germany

References

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Liese J et al. Effectiveness of one dose of varicella vaccine after introduction of routine varicella vaccination in Germany. Abstract presented at the 20th Congress of German Society for pediatric infectious diseases (GSPID). e.V.Mannheim, Germany, 19-21 April 2012.

Reference Type BACKGROUND

Liese J et al. Pediatric practice-based case-control study to evaluate the effectiveness of vaccination against laboratory-confirmed varicella in young children in Germany. Abstract presented at the 30th Annual Meeting of the European Society for Pediatric Infectious Diseases (ESPID) meeting, Thessaloniki, Greece 8-12 May 2012.

Reference Type BACKGROUND

Liese JG, Cohen C, Rack A, Pirzer K, Eber S, Blum M, Greenberg M, Streng A. The effectiveness of varicella vaccination in children in Germany: a case-control study. Pediatr Infect Dis J. 2013 Sep;32(9):998-1004. doi: 10.1097/INF.0b013e31829ae263.

Reference Type DERIVED
PMID: 23694831 (View on PubMed)

Other Identifiers

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109737

Identifier Type: -

Identifier Source: org_study_id