Clinical trial NCT00127010: Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Measles
Rubella
Mumps
Varicella
Keywords: Prophylaxis measles, mumps, rubella and chickenpox
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-08-05
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Eligibility 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

Primary outcomes:
measure: Antibody levels after vaccination
Secondary outcomes:
measure: Safety of the study vaccines
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Bad Saulgau
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Boennigheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ehingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kehl
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kirchzarten
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ludwigsburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Marbach
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Oberkirch
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Offenburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Schwaebisch-Hall
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tauberbischofsheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tettnang
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Bindlach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Cham
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Olching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Weilheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Werneck
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Eschwege
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Fulda
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Niedernhausen
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Wolfenbuettel
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Detmold
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Espelkamp
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Herford
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Hille
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kleve-Materborn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Krefeld
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Loehne
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Minden
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Porta Westfalica
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Viersen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Frankenthal
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Brunsbuettel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Gluecksburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Husum
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Neumuenster
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Neuhaus am Rennweg
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: