The Effectiveness of Varicella Vaccination in Children in Germany

Chickenpox Vaccines Clinical Trial

Official title:

The Effectiveness of Varicella Vaccination in Children in Germany

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679796
• Other study ID #: 109737
• Status: Completed
• Phase: N/A
• First received: May 13, 2008
• Last updated: October 25, 2012
• Start date: February 2008
• Est. completion date: October 2010

Study information

• Verified date: October 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1012
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chickenpox
• Chickenpox Vaccines
• Herpes Zoster
• Varicella (Chickenpox)

Intervention

Procedure:
• Varicella (chickenpox) lesion sampling

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Baldham	Bayern
Germany	GSK Investigational Site	Deisenhofen	Bayern
Germany	GSK Investigational Site	Freising	Bayern
Germany	GSK Investigational Site	Fuerstenfeldbruck	Bayern
Germany	GSK Investigational Site	Gilching	Bayern
Germany	GSK Investigational Site	Grafing	Bayern
Germany	GSK Investigational Site	Grafrath	Bayern
Germany	GSK Investigational Site	Kirchheim	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Olching	Bayern
Germany	GSK Investigational Site	Taufkirchen	Bayern
Germany	GSK Investigational Site	Weilheim	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of PCR-confirmed varicella cases in children administered one dose of Varilrix™ (= 28 days after receipt of vaccine) or in unvaccinated children.
Secondary	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
Secondary	Occurrence of PCR-confirmed severe varicella cases in children administered one dose of Varilrix™ (= 28 days after receipt of vaccine) or in unvaccinated children
Secondary	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
Secondary	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
Secondary	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