Immunogenicity and Safety of Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00126997
First received: August 4, 2005
Last updated: June 12, 2014
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Mumps
Rubella
Measles
Varicella
Biological: Measles, Mumps, Rubella and Chickenpox (live vaccine)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Antibody levels after vaccination. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of the study vaccines. [ Designated as safety issue: No ]

Enrollment: 1439
Study Start Date: May 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   11 Months to 21 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126997

  Hide Study Locations
Locations
Finland
GSK Investigational Site
Espoo, Finland, 02100
GSK Investigational Site
Lahti, Finland, 15140
GSK Investigational Site
Oulu, Finland, 90100
GSK Investigational Site
Pori, Finland, 28120
GSK Investigational Site
Tampere, Finland, 33200
GSK Investigational Site
Turku, Finland, 20520
GSK Investigational Site
Vantaa, Finland, 01300
Germany
GSK Investigational Site
Bayreuth, Bayern, Germany, 95444
GSK Investigational Site
Bindlach, Bayern, Germany, 95463
GSK Investigational Site
Bobingen, Bayern, Germany, 86399
GSK Investigational Site
Cham, Bayern, Germany, 93413
GSK Investigational Site
Kempten, Bayern, Germany, 87435
GSK Investigational Site
Muenchen, Bayern, Germany, 81241
GSK Investigational Site
Muenchen, Bayern, Germany, 81735
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
GSK Investigational Site
Nuernberg, Bayern, Germany, 90473
GSK Investigational Site
Olching, Bayern, Germany, 82140
GSK Investigational Site
Tegernsee, Bayern, Germany, 83684
GSK Investigational Site
Tutzing, Bayern, Germany, 82327
GSK Investigational Site
Veitshoechheim, Bayern, Germany, 97209
GSK Investigational Site
Eschwege, Hessen, Germany, 37269
GSK Investigational Site
Frankfurt, Hessen, Germany, 60389
GSK Investigational Site
Fulda, Hessen, Germany, 36037
GSK Investigational Site
Nidderau, Hessen, Germany, 61130
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65205
GSK Investigational Site
Salzgitter, Niedersachsen, Germany, 38226
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
GSK Investigational Site
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44866
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44329
GSK Investigational Site
Espelkamp, Nordrhein-Westfalen, Germany, 32339
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
GSK Investigational Site
Guetersloh, Nordrhein-Westfalen, Germany, 33332
GSK Investigational Site
Hille, Nordrhein-Westfalen, Germany, 32479
GSK Investigational Site
Kirchlengern, Nordrhein-Westfalen, Germany, 32278
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47798
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
GSK Investigational Site
Minden, Nordrhein-Westfalen, Germany, 32427
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41061
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41236
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48159
GSK Investigational Site
Wesseling, Nordrhein-Westfalen, Germany, 50389
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
Greece
GSK Investigational Site
Arta, Greece, 471 00
GSK Investigational Site
Athens, Greece, 11527
GSK Investigational Site
Komotini, Greece, 69100
GSK Investigational Site
Rhodes, Greece, 851 00
GSK Investigational Site
Thessaloniki, Greece, 54636
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-021
GSK Investigational Site
Krakow, Poland, 31-202
GSK Investigational Site
Poznan, Poland, 61-709
GSK Investigational Site
Siemianowice Slaskie, Poland, 41-103
GSK Investigational Site
Trzebnica, Poland, 55-100
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00126997     History of Changes
Other Study ID Numbers: 104020
Study First Received: August 4, 2005
Last Updated: June 12, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
Prophylaxis measles, mumps, rubella and chickenpox

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Measles
Mumps
Rubella
DNA Virus Infections
Herpesviridae Infections
Mononegavirales Infections
Morbillivirus Infections
Mouth Diseases
Paramyxoviridae Infections
Parotid Diseases
Parotitis
RNA Virus Infections
Rubivirus Infections
Rubulavirus Infections
Salivary Gland Diseases
Stomatognathic Diseases
Togaviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014