Clinical trial NCT00679796: The Effectiveness of Varicella Vaccination in Children in Germany
Official title: The Effectiveness of Varicella Vaccination in Children in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicella (Chickenpox)
Chickenpox Vaccines
Keywords: varicella
case-control
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2008-05-19
Enrollment: 1012
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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

Eligibility 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).

Primary outcomes:
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 outcomes:
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
measure: Occurrence of PCR-confirmed severe varicella cases in children administered one dose of Varilrix™ (≥ 28 days after receipt of vaccine) or in unvaccinated children
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
city: Baldham
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Deisenhofen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Freising
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Fuerstenfeldbruck
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Gilching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Grafing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Grafrath
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kirchheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Olching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Taufkirchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Weilheim
country: Germany
facility: GSK Investigational Site
state: Bayern
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.