Varicella (Chickenpox)NCT00679796
The Effectiveness of Varicella Vaccination in Children in Germany
An observational study of Varicella (Chickenpox) and Chickenpox Vaccines, run by GlaxoSmithKline at 33 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Varicella (Chickenpox), Chickenpox Vaccines
- What is being tested?
- Varicella (chickenpox) lesion sampling
- Type of treatment
- Surgery or procedure
- How many people
- 1,012 participants
- Where
- 33 sitesGermany
- Study dates
- Feb 2008to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Germany33 sites
GSK Investigational Site
Baldham, Bavaria, 85598
GSK Investigational Site
Deisenhofen, Bavaria, 82041
GSK Investigational Site
Freising, Bavaria, 85354
GSK Investigational Site
Fürstenfeldbruck, Bavaria, 82256
GSK Investigational Site
Gilching, Bavaria, 82205
GSK Investigational Site
Grafing, Bavaria, 85567
GSK Investigational Site
Grafrath, Bavaria, 82284
GSK Investigational Site
Kirchheim, Bavaria, 85551
GSK Investigational Site
Munich, Bavaria, 80339
GSK Investigational Site
Munich, Bavaria, 80538
GSK Investigational Site
Munich, Bavaria, 80796
GSK Investigational Site
Munich, Bavaria, 80802
GSK Investigational Site
Munich, Bavaria, 80804
GSK Investigational Site
Munich, Bavaria, 80939
GSK Investigational Site
Munich, Bavaria, 81241
GSK Investigational Site
Munich, Bavaria, 81243
GSK Investigational Site
Munich, Bavaria, 81247
GSK Investigational Site
Munich, Bavaria, 81249
GSK Investigational Site
Munich, Bavaria, 81369
GSK Investigational Site
Munich, Bavaria, 81371
GSK Investigational Site
Munich, Bavaria, 81375
GSK Investigational Site
Munich, Bavaria, 81377
GSK Investigational Site
Munich, Bavaria, 81479
GSK Investigational Site
Munich, Bavaria, 81543
GSK Investigational Site
Munich, Bavaria, 81545
GSK Investigational Site
Munich, Bavaria, 81547
GSK Investigational Site
Munich, Bavaria, 81669
GSK Investigational Site
Munich, Bavaria, 81735
GSK Investigational Site
Munich, Bavaria, 81737
GSK Investigational Site
Munich, Bavaria, 81925
GSK Investigational Site
Olching, Bavaria, 82140
GSK Investigational Site
Taufkirchen, Bavaria, 82024
GSK Investigational Site
Weilheim, Bavaria, 82362
About this study
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.
Read the detailed description
Observational, multicenter, population-based, matched case-control study conducted in selected pediatric practices in the Munich area.
- Conditions
- Varicella (Chickenpox), Chickenpox Vaccines
- Being tested
- Varicella (chickenpox) lesion sampling
- Keywords
- varicella, case-control
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varicella (chickenpox) lesion samplingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A | Subjects with PCR confirmed varicella Receives: Procedure: Varicella (chickenpox) lesion sampling | |
| Group B | Age- and practice-matched control subjects Receives: Procedure: Varicella (chickenpox) lesion sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startFeb 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Varicella (Chickenpox)Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ludwig-Maximilians - University of Munich
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679796
- Sponsor's protocol ID
- 109737
- Status last verified
- Oct 2012
- First submitted
- 13 May 2008
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
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.
PubMed 23694831
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Varicella Vaccination in Children in Germany
- ClinicalTrials.gov ID
- NCT00679796
- Acronym / sponsor ID
- 109737
- Conditions
- Varicella (Chickenpox), Chickenpox Vaccines
- Keywords
- varicella, case-control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,012 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Ludwig-Maximilians - University of Munich
- Study start
- Feb 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Varicella (chickenpox) lesion samplingSubjects with PCR confirmed varicella |
| Group B | – | Procedure: Varicella (chickenpox) lesion samplingAge- and practice-matched control subjects |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (7 listed)
- Ineligible for varicella vaccination, due to any medical contraindication. These contraindications are:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varicella (chickenpox) lesion sampling | Procedure or surgery | Group A, Group B |
Primary outcome
Occurrence of PCR-confirmed varicella cases in children administered one dose of Varilrix™ (≥ 28 days after receipt of vaccine) or in unvaccinated children.
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
- BackgroundLiese 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.
- BackgroundLiese 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.
- Derived from this study: PubMed 23694831Liese 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicella (Chickenpox) and Chickenpox Vaccines, run by GlaxoSmithKline at 33 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of PCR-confirmed varicella cases in children administered one dose of Varilrix™ (≥ 28 days after receipt of vaccine) or in unvaccinated children.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00679796, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2012.