The Effectiveness of Varicella Vaccination in Children in Germany

NCT00679796 | Completed

• 1 other identifier: 109737
• Study Type: observational
• Target: 1,012
• Locations: 1 country
• Sites: 33

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.

Conditions

Varicella (Chickenpox); Chickenpox Vaccines

Keywords

varicella; case-control

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• 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

Study Arms (2)

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

Interventions

Varicella (chickenpox) lesion sampling PROCEDURE

Group A; Group B

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Suspected primary varicella disease (i.e. chickenpox) at the time of study entry

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (33)

GSK Investigational Site

Baldham, Bavaria, 85598, Germany

Location

GSK Investigational Site

Deisenhofen, Bavaria, 82041, Germany

Location

GSK Investigational Site

Freising, Bavaria, 85354, Germany

Location

GSK Investigational Site

Fürstenfeldbruck, Bavaria, 82256, Germany

Location

GSK Investigational Site

Gilching, Bavaria, 82205, Germany

Location

GSK Investigational Site

Grafing, Bavaria, 85567, Germany

Location

GSK Investigational Site

Grafrath, Bavaria, 82284, Germany

Location

GSK Investigational Site

Kirchheim, Bavaria, 85551, Germany

Location

GSK Investigational Site

Munich, Bavaria, 80339, Germany

Location

GSK Investigational Site

Munich, Bavaria, 80538, Germany

Location

GSK Investigational Site

Munich, Bavaria, 80796, Germany

Location

GSK Investigational Site

Munich, Bavaria, 80802, Germany

Location

GSK Investigational Site

Munich, Bavaria, 80804, Germany

Location

GSK Investigational Site

Munich, Bavaria, 80939, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81241, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81243, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81247, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81249, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81369, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81371, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81375, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81377, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81479, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81543, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81545, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81547, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81669, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81735, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81737, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81925, Germany

Location

GSK Investigational Site

Olching, Bavaria, 82140, Germany

Location

GSK Investigational Site

Taufkirchen, Bavaria, 82024, Germany

Location

GSK Investigational Site

Weilheim, Bavaria, 82362, Germany

Location

Related Publications (3)

• 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.

  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.

  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.

  PMID: 23694831 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

samples from skin lesions

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2008
• First Posted: May 19, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 29, 2012

Record last verified: 2012-10

Locations

DE (33)