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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00127010
Other study ID # 103388
Secondary ID
Status Completed
Phase Phase 3
First received August 4, 2005
Last updated September 23, 2016
Start date November 2005
Est. completion date June 2006

Study information

Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Months to 13 Months
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Measles, Mumps, Rubella and Chickenpox (live vaccine)


Locations

Country Name City State
Belgium GSK Investigational Site Brussel
Belgium GSK Investigational Site Leuven
Germany GSK Investigational Site Bad Saulgau Baden-Wuerttemberg
Germany GSK Investigational Site Bindlach Bayern
Germany GSK Investigational Site Bochum Nordrhein-Westfalen
Germany GSK Investigational Site Boennigheim Baden-Wuerttemberg
Germany GSK Investigational Site Brunsbuettel Schleswig-Holstein
Germany GSK Investigational Site Cham Bayern
Germany GSK Investigational Site Detmold Nordrhein-Westfalen
Germany GSK Investigational Site Dortmund Nordrhein-Westfalen
Germany GSK Investigational Site Ehingen Baden-Wuerttemberg
Germany GSK Investigational Site Eschwege Hessen
Germany GSK Investigational Site Espelkamp Nordrhein-Westfalen
Germany GSK Investigational Site Flensburg Schleswig-Holstein
Germany GSK Investigational Site Frankenthal Rheinland-Pfalz
Germany GSK Investigational Site Fulda Hessen
Germany GSK Investigational Site Gluecksburg Schleswig-Holstein
Germany GSK Investigational Site Herford Nordrhein-Westfalen
Germany GSK Investigational Site Hille Nordrhein-Westfalen
Germany GSK Investigational Site Husum Schleswig-Holstein
Germany GSK Investigational Site Kehl Baden-Wuerttemberg
Germany GSK Investigational Site Kirchzarten Baden-Wuerttemberg
Germany GSK Investigational Site Kleve-Materborn Nordrhein-Westfalen
Germany GSK Investigational Site Krefeld Nordrhein-Westfalen
Germany GSK Investigational Site Loehne Nordrhein-Westfalen
Germany GSK Investigational Site Ludwigsburg Baden-Wuerttemberg
Germany GSK Investigational Site Marbach Baden-Wuerttemberg
Germany GSK Investigational Site Minden Nordrhein-Westfalen
Germany GSK Investigational Site Muenchen Bayern
Germany GSK Investigational Site Muenchen Bayern
Germany GSK Investigational Site Muenster Nordrhein-Westfalen
Germany GSK Investigational Site Neuhaus am Rennweg Thueringen
Germany GSK Investigational Site Neumuenster Schleswig-Holstein
Germany GSK Investigational Site Niedernhausen Hessen
Germany GSK Investigational Site Oberkirch Baden-Wuerttemberg
Germany GSK Investigational Site Offenburg Baden-Wuerttemberg
Germany GSK Investigational Site Olching Bayern
Germany GSK Investigational Site Porta Westfalica Nordrhein-Westfalen
Germany GSK Investigational Site Schwaebisch-Hall Baden-Wuerttemberg
Germany GSK Investigational Site Stuttgart Baden-Wuerttemberg
Germany GSK Investigational Site Tauberbischofsheim Baden-Wuerttemberg
Germany GSK Investigational Site Tettnang Baden-Wuerttemberg
Germany GSK Investigational Site Trier Rheinland-Pfalz
Germany GSK Investigational Site Viersen Nordrhein-Westfalen
Germany GSK Investigational Site Weilheim Bayern
Germany GSK Investigational Site Werneck Bayern
Germany GSK Investigational Site Wolfenbuettel Niedersachsen
Netherlands GSK Investigational Site Rotterdam

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antibody levels after vaccination
Secondary Safety of the study vaccines
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