Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00127010

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety Study
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:

MedlinePlus related topics: Chickenpox Measles Mumps Rubella Shingles

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

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

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Locations

Belgium
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Brussels, Belgium, 1090
Germany, Baden-Wuerttemberg
GSK Investigational Site
Tettnang, Baden-Wuerttemberg, Germany, 88069
GSK Investigational Site
Boennigheim, Baden-Wuerttemberg, Germany, 74357
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
GSK Investigational Site
Ludwigsburg, Baden-Wuerttemberg, Germany, 71634
GSK Investigational Site
Kirchzarten, Baden-Wuerttemberg, Germany, 79199
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
GSK Investigational Site
Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
GSK Investigational Site
Ehingen, Baden-Wuerttemberg, Germany, 89584
GSK Investigational Site
Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
Germany, Bayern
GSK Investigational Site
Bindlach, Bayern, Germany, 95463
GSK Investigational Site
Werneck, Bayern, Germany, 97440
GSK Investigational Site
Muenchen, Bayern, Germany, 81241
Germany, Hessen
GSK Investigational Site
Fulda, Hessen, Germany, 36037
GSK Investigational Site
Eschwege, Hessen, Germany, 37269
Germany, Niedersachsen
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
Germany, Nordrhein-Westfalen
GSK Investigational Site
Espelkamp, Nordrhein-Westfalen, Germany, 32339
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44866
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47798
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44329
GSK Investigational Site
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48163
GSK Investigational Site
Hille, Nordrhein-Westfalen, Germany, 32479
GSK Investigational Site
Minden, Nordrhein-Westfalen, Germany, 32427
GSK Investigational Site
Herford, Nordrhein-Westfalen, Germany, 32049
GSK Investigational Site
Viersen, Nordrhein-Westfalen, Germany, 41749
GSK Investigational Site
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
Germany, Rheinland-Pfalz
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
GSK Investigational Site
Schöneberg - Kübelberg, Rheinland-Pfalz, Germany, 66901
Germany, Schleswig-Holstein
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
GSK Investigational Site
Gluecksburg, Schleswig-Holstein, Germany, 24960
GSK Investigational Site
Neumuenster, Schleswig-Holstein, Germany, 24534
Germany, Thueringen
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:	GSK ( Study Director )
Study ID Numbers:	103388
Study First Received:	August 4, 2005
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00127010 History of Changes
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:

Mouth Diseases
RNA Virus Infections
Morbillivirus Infections
Paramyxoviridae Infections
Measles
Rubulavirus Infections
Chickenpox
Sialadenitis
Rubella
Togaviridae Infections

Herpesviridae Infections
Virus Diseases
Rubivirus Infections
Parotid Diseases
DNA Virus Infections
Stomatognathic Diseases
Salivary Gland Diseases
Mumps
Parotitis
Mononegavirales Infections

ClinicalTrials.gov processed this record on November 27, 2009