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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00127010
First received: August 4, 2005
Last updated: October 9, 2008
Last verified: October 2008
History of Changes
  Purpose

This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.


Condition Intervention Phase
Measles
Mumps
Rubella
Chickenpox
 Biological: Measles, Mumps, Rubella and Chickenpox (live vaccine)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Blinded, Randomized Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Measles-Mumps-Rubella-Varicella Candidate Vaccine Given to Healthy Children During the Second Year of Life

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Antibody levels after vaccination

Secondary Outcome Measures:
  • Safety of the study vaccines

Study Start Date: November 2005
Intervention Details:
    Biological: Measles, Mumps, Rubella and Chickenpox (live vaccine)
    Other Name: Measles, Mumps, Rubella and Chickenpox (live vaccine)
Detailed Description:

This study included an active control group who received the licensed Priorix (measles, mumps, rubella [MMR] vaccine).

  Eligibility

Ages Eligible for Study:   11 Months to 13 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127010

Locations
Belgium
GSK Investigational Site
Brussels, Belgium, 1090
GSK Investigational Site
Leuven, Belgium, 3000
Germany
GSK Investigational Site
Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
GSK Investigational Site
Boennigheim, Baden-Wuerttemberg, Germany, 74357
GSK Investigational Site
Ehingen, Baden-Wuerttemberg, Germany, 89584
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
GSK Investigational Site
Kirchzarten, Baden-Wuerttemberg, Germany, 79199
GSK Investigational Site
Ludwigsburg, Baden-Wuerttemberg, Germany, 71634
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
GSK Investigational Site
Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
GSK Investigational Site
Tettnang, Baden-Wuerttemberg, Germany, 88069
GSK Investigational Site
Bindlach, Bayern, Germany, 95463
GSK Investigational Site
Muenchen, Bayern, Germany, 81241
GSK Investigational Site
Werneck, Bayern, Germany, 97440
GSK Investigational Site
Eschwege, Hessen, Germany, 37269
GSK Investigational Site
Fulda, Hessen, Germany, 36037
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
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
Herford, Nordrhein-Westfalen, Germany, 32049
GSK Investigational Site
Hille, Nordrhein-Westfalen, Germany, 32479
GSK Investigational Site
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
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
Muenster, Nordrhein-Westfalen, Germany, 48163
GSK Investigational Site
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
GSK Investigational Site
Viersen, Nordrhein-Westfalen, Germany, 41749
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
GSK Investigational Site
Schöneberg - Kübelberg, Rheinland-Pfalz, Germany, 66901
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
GSK Investigational Site
Gluecksburg, Schleswig-Holstein, Germany, 24960
GSK Investigational Site
Neumuenster, Schleswig-Holstein, Germany, 24534
GSK Investigational Site
Neuhaus am Rennweg, Thueringen, Germany, 98724
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00127010     History of Changes
Other Study ID Numbers: 103388
Study First Received: August 4, 2005
Last Updated: October 9, 2008
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

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

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

ClinicalTrials.gov processed this record on May 23, 2013