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CompletedNCT00127023Updated Sep 21, 2016

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

A Phase 3 interventional study of Measles, Mumps, Rubella and Chickenpox (live vaccine) in Mumps, Varicella and Rubella, sponsored by GlaxoSmithKline. Completed at 85 sites in Germany. Open to participants aged 11 Months to 21 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-21.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
944
Allocation
Randomized
Ages
11 Months to 21 Months
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Mumps
  • Varicella
  • Rubella
  • Measles

Keywords

  • Prophylaxis measles, mumps, rubella and chickenpox
03

In context

Mumps

83 studies on the registry are indexed under Mumps; 8 are open to participants now.

This study's enrollment of 944 is close to the median of 897 across 70 interventional studies indexed under Mumps.

Browse Mumps studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Months to 21 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
944 participants

Interventions

  • BiologicalMeasles, Mumps, Rubella and Chickenpox (live vaccine)

    Drug page: Measles-Mumps-Rubella Vaccine

    Also known as: Measles, Mumps, Rubella and Chickenpox (live vaccine)

06

What researchers measure

Primary outcomes

  1. Antibody levels after vaccination.

Secondary outcomes

  1. Safety of the study vaccines.

07

Study locations

85 sites
  • GSK Investigational Site
    Bad Saulgau, Baden-Wuerttemberg 88348, Germany
  • GSK Investigational Site
    Boennigheim, Baden-Wuerttemberg 74357, Germany
  • GSK Investigational Site
    Bretten, Baden-Wuerttemberg 75015, Germany
  • GSK Investigational Site
    Ehingen, Baden-Wuerttemberg 89584, Germany
  • GSK Investigational Site
    Eppelheim, Baden-Wuerttemberg 69214, Germany
  • GSK Investigational Site
    Ettenheim, Baden-Wuerttemberg 77955, Germany
  • GSK Investigational Site
    Herbolzheim, Baden-Wuerttemberg 79336, Germany
  • GSK Investigational Site
    Karlsruhe, Baden-Wuerttemberg 76185, Germany
  • GSK Investigational Site
    Kehl, Baden-Wuerttemberg 77694, Germany
  • GSK Investigational Site
    Kirchzarten, Baden-Wuerttemberg 79199, Germany
  • GSK Investigational Site
    Ludwigsburg, Baden-Wuerttemberg 71634, Germany
  • GSK Investigational Site
    Mannheim, Baden-Wuerttemberg 68161, Germany
  • GSK Investigational Site
    Mannheim, Baden-Wuerttemberg 68309, Germany
  • GSK Investigational Site
    Marbach, Baden-Wuerttemberg 71672, Germany
  • GSK Investigational Site
    Oberkirch, Baden-Wuerttemberg 77704, Germany
  • GSK Investigational Site
    Oberstenfeld, Baden-Wuerttemberg 71720, Germany
  • GSK Investigational Site
    Offenburg, Baden-Wuerttemberg 77654, Germany
  • GSK Investigational Site
    Offenburg, Baden-Wuerttemberg 77656, Germany
  • GSK Investigational Site
    Pfinztal, Baden-Wuerttemberg 76327, Germany
  • GSK Investigational Site
    Schwaebisch-Hall, Baden-Wuerttemberg 74523, Germany
  • GSK Investigational Site
    Stuttgart, Baden-Wuerttemberg 70469, Germany
  • GSK Investigational Site
    Tauberbischofsheim, Baden-Wuerttemberg 97941, Germany
  • GSK Investigational Site
    Tettnang, Baden-Wuerttemberg 88069, Germany
  • GSK Investigational Site
    Augsburg, Bayern 86163, Germany
  • GSK Investigational Site
    Bindlach, Bayern 95463, Germany
  • GSK Investigational Site
    Marktheidenfeld, Bayern 97828, Germany
  • GSK Investigational Site
    Muenchen, Bayern 81241, Germany
  • GSK Investigational Site
    Nuernberg, Bayern 90473, Germany
  • GSK Investigational Site
    Roding, Bayern 93426, Germany
  • GSK Investigational Site
    Fulda, Hessen 36037, Germany
  • GSK Investigational Site
    Buetzow, Mecklenburg-Vorpommern 18246, Germany
  • GSK Investigational Site
    Rostock, Mecklenburg-Vorpommern 18059, Germany
  • GSK Investigational Site
    Rostock, Mecklenburg-Vorpommern 18146, Germany
  • GSK Investigational Site
    Waren, Mecklenburg-Vorpommern 17192, Germany
  • GSK Investigational Site
    Salzgitter, Niedersachsen 38226, Germany
  • GSK Investigational Site
    Wolfenbuettel, Niedersachsen 38302, Germany
  • GSK Investigational Site
    Bad Oeynhausen, Nordrhein-Westfalen 32549, Germany
  • GSK Investigational Site
    Bochum, Nordrhein-Westfalen 44866, Germany
  • GSK Investigational Site
    Detmold, Nordrhein-Westfalen 32756, Germany
  • GSK Investigational Site
    Erkrath, Nordrhein-Westfalen 40699, Germany
  • GSK Investigational Site
    Heiligenhaus, Nordrhein-Westfalen 42579, Germany
  • GSK Investigational Site
    Hille, Nordrhein-Westfalen 32479, Germany
  • GSK Investigational Site
    Kleve-Materborn, Nordrhein-Westfalen 47533, Germany
  • GSK Investigational Site
    Krefeld, Nordrhein-Westfalen 47798, Germany
  • GSK Investigational Site
    Oberhausen, Nordrhein-Westfalen 46145, Germany
  • GSK Investigational Site
    Willich, Nordrhein-Westfalen 47877, Germany
  • GSK Investigational Site
    Bad Kreuznach, Rheinland-Pfalz 55543, Germany
  • GSK Investigational Site
    Bodenheim, Rheinland-Pfalz 55294, Germany
  • GSK Investigational Site
    Frankenthal, Rheinland-Pfalz 67227, Germany
  • GSK Investigational Site
    Gerolstein, Rheinland-Pfalz 54568, Germany
  • GSK Investigational Site
    Ludwigshafen, Rheinland-Pfalz 67059, Germany
  • GSK Investigational Site
    Mainz, Rheinland-Pfalz 55131, Germany
  • GSK Investigational Site
    Trier, Rheinland-Pfalz 54290, Germany
  • GSK Investigational Site
    Trier, Rheinland-Pfalz 54294, Germany
  • GSK Investigational Site
    Worms, Rheinland-Pfalz 67547, Germany
  • GSK Investigational Site
    Bischofswerda, Sachsen 01877, Germany
  • GSK Investigational Site
    Doebeln, Sachsen 04720, Germany
  • GSK Investigational Site
    Dresden, Sachsen 01169, Germany
  • GSK Investigational Site
    Leipzig, Sachsen 04178, Germany
  • GSK Investigational Site
    Leipzig, Sachsen 04317, Germany
  • GSK Investigational Site
    Stollberg, Sachsen 09366, Germany
  • GSK Investigational Site
    Bredstedt, Schleswig-Holstein 25821, Germany
  • GSK Investigational Site
    Brunsbuettel, Schleswig-Holstein 25541, Germany
  • GSK Investigational Site
    Flensburg, Schleswig-Holstein 24937, Germany
  • GSK Investigational Site
    Flensburg, Schleswig-Holstein 24943, Germany
  • GSK Investigational Site
    Flensburg, Schleswig-Holstein 24944, Germany
  • GSK Investigational Site
    Harrislee, Schleswig-Holstein 24955, Germany
  • GSK Investigational Site
    Husum, Schleswig-Holstein 25813, Germany
  • GSK Investigational Site
    Moelln, Schleswig-Holstein 23879, Germany
  • GSK Investigational Site
    Neumuenster, Schleswig-Holstein 24534, Germany
  • GSK Investigational Site
    Niebuell, Schleswig-Holstein 25899, Germany
  • GSK Investigational Site
    Lobenstein, Thueringen 07356, Germany
  • GSK Investigational Site
    Neuhaus am Rennweg, Thueringen 98724, Germany
  • GSK Investigational Site
    Weimar, Thueringen 99425, Germany
  • GSK Investigational Site
    Berlin, 10315, Germany
  • GSK Investigational Site
    Berlin, 10967, Germany
  • GSK Investigational Site
    Berlin, 10999, Germany
  • GSK Investigational Site
    Berlin, 12627, Germany
  • GSK Investigational Site
    Berlin, 12679, Germany
  • GSK Investigational Site
    Berlin, 13055, Germany
  • GSK Investigational Site
    Berlin, 13355, Germany
  • GSK Investigational Site
    Berlin, 14197, Germany
  • GSK Investigational Site
    Hamburg, 22089, Germany
  • GSK Investigational Site
    Hamburg, 22143, Germany
  • GSK Investigational Site
    Hamburg, 22307, Germany
08

References and documents

Publications

  • 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. PubMed 18600190 ↗
  • 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.
  • Dhillon S, Curran MP. Live attenuated measles, mumps, rubella, and varicella zoster virus vaccine (Priorix-Tetra). Paediatr Drugs. 2008;10(5):337-47. doi: 10.2165/00148581-200810050-00007. PubMed 18754700 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00127023
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 5, 2005
Start date
May 2005
Completion
Nov 2005
Last update
Sep 21, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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