- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00126997
Immunogenicity and Safety of Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
September 20, 2016 updated by: GlaxoSmithKline
Blinded, Randomised Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Live Attenuated Measles-mumps-rubella-varicella Candidate Vaccine When Given to Healthy Children in Their Second Year of Life
This is a study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals live attenuated measles-mumps-rubella-varicella vaccine given to healthy children in their second year of life.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1439
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Espoo, Finland, 02100
- GSK Investigational Site
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Lahti, Finland, 15140
- GSK Investigational Site
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Oulu, Finland, 90100
- GSK Investigational Site
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Pori, Finland, 28120
- GSK Investigational Site
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Tampere, Finland, 33200
- GSK Investigational Site
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Turku, Finland, 20520
- GSK Investigational Site
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Vantaa, Finland, 01300
- GSK Investigational Site
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Bayern
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Bayreuth, Bayern, Germany, 95444
- GSK Investigational Site
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Bindlach, Bayern, Germany, 95463
- GSK Investigational Site
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Bobingen, Bayern, Germany, 86399
- GSK Investigational Site
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Cham, Bayern, Germany, 93413
- GSK Investigational Site
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Kempten, Bayern, Germany, 87435
- GSK Investigational Site
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Muenchen, Bayern, Germany, 81735
- GSK Investigational Site
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Muenchen, Bayern, Germany, 81241
- GSK Investigational Site
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Noerdlingen, Bayern, Germany, 86720
- GSK Investigational Site
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Nuernberg, Bayern, Germany, 90473
- GSK Investigational Site
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Olching, Bayern, Germany, 82140
- GSK Investigational Site
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Tegernsee, Bayern, Germany, 83684
- GSK Investigational Site
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Tutzing, Bayern, Germany, 82327
- GSK Investigational Site
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Veitshoechheim, Bayern, Germany, 97209
- GSK Investigational Site
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Hessen
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Eschwege, Hessen, Germany, 37269
- GSK Investigational Site
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Frankfurt, Hessen, Germany, 60389
- GSK Investigational Site
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Fulda, Hessen, Germany, 36037
- GSK Investigational Site
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Nidderau, Hessen, Germany, 61130
- GSK Investigational Site
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Wiesbaden, Hessen, Germany, 65205
- GSK Investigational Site
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Niedersachsen
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Salzgitter, Niedersachsen, Germany, 38226
- GSK Investigational Site
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Wolfenbuettel, Niedersachsen, Germany, 38302
- GSK Investigational Site
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Nordrhein-Westfalen
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Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549
- GSK Investigational Site
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Bochum, Nordrhein-Westfalen, Germany, 44866
- GSK Investigational Site
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Detmold, Nordrhein-Westfalen, Germany, 32756
- GSK Investigational Site
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Dortmund, Nordrhein-Westfalen, Germany, 44329
- GSK Investigational Site
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Espelkamp, Nordrhein-Westfalen, Germany, 32339
- GSK Investigational Site
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Goch, Nordrhein-Westfalen, Germany, 47574
- GSK Investigational Site
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Guetersloh, Nordrhein-Westfalen, Germany, 33332
- GSK Investigational Site
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Hille, Nordrhein-Westfalen, Germany, 32479
- GSK Investigational Site
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Kirchlengern, Nordrhein-Westfalen, Germany, 32278
- GSK Investigational Site
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Krefeld, Nordrhein-Westfalen, Germany, 47798
- GSK Investigational Site
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Loehne, Nordrhein-Westfalen, Germany, 32584
- GSK Investigational Site
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Minden, Nordrhein-Westfalen, Germany, 32427
- GSK Investigational Site
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Moenchengladbach, Nordrhein-Westfalen, Germany, 41061
- GSK Investigational Site
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Moenchengladbach, Nordrhein-Westfalen, Germany, 41236
- GSK Investigational Site
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Muenster, Nordrhein-Westfalen, Germany, 48159
- GSK Investigational Site
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Wesseling, Nordrhein-Westfalen, Germany, 50389
- GSK Investigational Site
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Willich, Nordrhein-Westfalen, Germany, 47877
- GSK Investigational Site
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Arta, Greece, 471 00
- GSK Investigational Site
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Athens, Greece, 11527
- GSK Investigational Site
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Komotini, Greece, 69100
- GSK Investigational Site
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Rhodes, Greece, 851 00
- GSK Investigational Site
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Thessaloniki, Greece, 54636
- GSK Investigational Site
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Bydgoszcz, Poland, 85-021
- GSK Investigational Site
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Krakow, Poland, 31-202
- GSK Investigational Site
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Poznan, Poland, 61-709
- GSK Investigational Site
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Siemianowice Slaskie, Poland, 41-103
- GSK Investigational Site
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Trzebnica, Poland, 55-100
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 months to 1 year (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A male or female subject between 11-13 months of age (i.e. from 11 month birthday until the day before the 14 month birthday) at the time of the first vaccination.
Exclusion Criteria:
- History of previous measles, mumps, rubella and/or varicella vaccination or disease, or known exposure to any of these diseases within 30 days prior to the start of the trial
- Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Antibody levels after vaccination.
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Secondary Outcome Measures
Outcome Measure |
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Safety of the study vaccines.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
November 1, 2005
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
August 4, 2005
First Submitted That Met QC Criteria
August 4, 2005
First Posted (Estimate)
August 5, 2005
Study Record Updates
Last Update Posted (Estimate)
September 21, 2016
Last Update Submitted That Met QC Criteria
September 20, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Stomatognathic Diseases
- Mouth Diseases
- DNA Virus Infections
- Morbillivirus Infections
- Paramyxoviridae Infections
- Mononegavirales Infections
- Herpesviridae Infections
- Varicella Zoster Virus Infection
- Salivary Gland Diseases
- Togaviridae Infections
- Rubivirus Infections
- Rubulavirus Infections
- Parotitis
- Parotid Diseases
- Measles
- Herpes Zoster
- Chickenpox
- Rubella
- Mumps
Other Study ID Numbers
- 104020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Dataset Specification
Information identifier: 104020Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 104020Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 104020Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 104020Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 104020Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 104020Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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