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

Measles Clinical Trial

Official title:

Blinded, Randomised, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Combined Measles-mumps-rubella-varicella Candidate Vaccine Given to Healthy Children in Their Second Year of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127023
• Other study ID #: 104389
• Status: Completed
• Phase: Phase 3
• First received: August 4, 2005
• Last updated: September 20, 2016
• Start date: May 2005
• Est. completion date: November 2005

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• 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:

Separate injections of the licensed Priorix (MMR vaccine) and Varilrix (chickenpox vaccine) serve as control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 944
• Est. completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Months to 21 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: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Measles
• Mumps
• Rubella
• Varicella

Intervention

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

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Bad Kreuznach	Rheinland-Pfalz
Germany	GSK Investigational Site	Bad Oeynhausen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bad Saulgau	Baden-Wuerttemberg
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bindlach	Bayern
Germany	GSK Investigational Site	Bischofswerda	Sachsen
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bodenheim	Rheinland-Pfalz
Germany	GSK Investigational Site	Boennigheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Bredstedt	Schleswig-Holstein
Germany	GSK Investigational Site	Bretten	Baden-Wuerttemberg
Germany	GSK Investigational Site	Brunsbuettel	Schleswig-Holstein
Germany	GSK Investigational Site	Buetzow	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Detmold	Nordrhein-Westfalen
Germany	GSK Investigational Site	Doebeln	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Ehingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Eppelheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Erkrath	Nordrhein-Westfalen
Germany	GSK Investigational Site	Ettenheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Frankenthal	Rheinland-Pfalz
Germany	GSK Investigational Site	Fulda	Hessen
Germany	GSK Investigational Site	Gerolstein	Rheinland-Pfalz
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Harrislee	Schleswig-Holstein
Germany	GSK Investigational Site	Heiligenhaus	Nordrhein-Westfalen
Germany	GSK Investigational Site	Herbolzheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Hille	Nordrhein-Westfalen
Germany	GSK Investigational Site	Husum	Schleswig-Holstein
Germany	GSK Investigational Site	Karlsruhe	Baden-Wuerttemberg
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	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Lobenstein	Thueringen
Germany	GSK Investigational Site	Ludwigsburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Ludwigshafen	Rheinland-Pfalz
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Marbach	Baden-Wuerttemberg
Germany	GSK Investigational Site	Marktheidenfeld	Bayern
Germany	GSK Investigational Site	Moelln	Schleswig-Holstein
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Neuhaus am Rennweg	Thueringen
Germany	GSK Investigational Site	Neumuenster	Schleswig-Holstein
Germany	GSK Investigational Site	Niebuell	Schleswig-Holstein
Germany	GSK Investigational Site	Nuernberg	Bayern
Germany	GSK Investigational Site	Oberhausen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Oberkirch	Baden-Wuerttemberg
Germany	GSK Investigational Site	Oberstenfeld	Baden-Wuerttemberg
Germany	GSK Investigational Site	Offenburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Offenburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Pfinztal	Baden-Wuerttemberg
Germany	GSK Investigational Site	Roding	Bayern
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Salzgitter	Niedersachsen
Germany	GSK Investigational Site	Schwaebisch-Hall	Baden-Wuerttemberg
Germany	GSK Investigational Site	Stollberg	Sachsen
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	Trier	Rheinland-Pfalz
Germany	GSK Investigational Site	Waren	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Weimar	Thueringen
Germany	GSK Investigational Site	Willich	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wolfenbuettel	Niedersachsen
Germany	GSK Investigational Site	Worms	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Dhillon S, Curran MP. Live attenuated measles, mumps, rubella, and varicella zoster virus vaccine (Priorix-Tetra). Paediatr Drugs. 2008;10(5):337-47. Review. — View Citation

Schuster V et al. Immunogenicity of a Refrigerator-Stable Tetravalent MMRV Vaccine after One and Two Doses. Presented at the 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 3-5 May 2006.

Schuster V et al. Tolerability of a Refrigerator-Stable Tetravalent MMRV vaccine after One and Two Doses. Presented at the 12th International Congress on Infectious Diseases (ICID), Lisbon, Portugal, 15-18 June 2006.

Schuster V, Otto W, Maurer L, Tcherepnine P, Pfletschinger U, Kindler K, Soemantri P, Walther U, Macholdt U, Douha M, Pierson P, Willems P. Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life. Pediatr Infect Dis J. 2008 Aug;27(8):724-30. doi: 10.1097/INF.0b013e318170bb22. Erratum in: Pediatr Infect Dis J. 2013 Apr;32(4):e163. — View Citation

Outcome

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

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.