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CompletedNCT00127010Updated Sep 26, 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 Measles, Rubella and Mumps, sponsored by GlaxoSmithKline. Completed at 48 sites in 3 countries. Open to participants aged 11 Months to 13 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-26.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
11 Months to 13 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

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

02

Conditions studied

  • Measles
  • Rubella
  • Mumps
  • Varicella

Keywords

  • Prophylaxis measles, mumps, rubella and chickenpox
03

In context

Measles

134 studies on the registry are indexed under Measles; 17 are open to participants now.

Browse Measles 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.

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

04

Who can participate

Ages eligible
11 Months to 13 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
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

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

48 sites
  • GSK Investigational Site
    Brussel, 1090, Belgium
  • GSK Investigational Site
    Leuven, 3000, Belgium
  • GSK Investigational Site
    Bad Saulgau, Baden-Wuerttemberg 88348, Germany
  • GSK Investigational Site
    Boennigheim, Baden-Wuerttemberg 74357, Germany
  • GSK Investigational Site
    Ehingen, Baden-Wuerttemberg 89584, 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
    Marbach, Baden-Wuerttemberg 71672, Germany
  • GSK Investigational Site
    Oberkirch, Baden-Wuerttemberg 77704, Germany
  • GSK Investigational Site
    Offenburg, Baden-Wuerttemberg 77654, 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
    Bindlach, Bayern 95463, Germany
  • GSK Investigational Site
    Cham, Bayern 93413, Germany
  • GSK Investigational Site
    Muenchen, Bayern 81241, Germany
  • GSK Investigational Site
    Muenchen, Bayern 81735, Germany
  • GSK Investigational Site
    Olching, Bayern 82140, Germany
  • GSK Investigational Site
    Weilheim, Bayern 82362, Germany
  • GSK Investigational Site
    Werneck, Bayern 97440, Germany
  • GSK Investigational Site
    Eschwege, Hessen 37269, Germany
  • GSK Investigational Site
    Fulda, Hessen 36037, Germany
  • GSK Investigational Site
    Niedernhausen, Hessen 65527, Germany
  • GSK Investigational Site
    Wolfenbuettel, Niedersachsen 38302, Germany
  • GSK Investigational Site
    Bochum, Nordrhein-Westfalen 44866, Germany
  • GSK Investigational Site
    Detmold, Nordrhein-Westfalen 32756, Germany
  • GSK Investigational Site
    Dortmund, Nordrhein-Westfalen 44329, Germany
  • GSK Investigational Site
    Espelkamp, Nordrhein-Westfalen 32339, Germany
  • GSK Investigational Site
    Herford, Nordrhein-Westfalen 32049, 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
    Loehne, Nordrhein-Westfalen 32584, Germany
  • GSK Investigational Site
    Minden, Nordrhein-Westfalen 32427, Germany
  • GSK Investigational Site
    Muenster, Nordrhein-Westfalen 48163, Germany
  • GSK Investigational Site
    Porta Westfalica, Nordrhein-Westfalen 32457, Germany
  • GSK Investigational Site
    Viersen, Nordrhein-Westfalen 41749, Germany
  • GSK Investigational Site
    Frankenthal, Rheinland-Pfalz 67227, Germany
  • GSK Investigational Site
    Trier, Rheinland-Pfalz 54290, Germany
  • GSK Investigational Site
    Brunsbuettel, Schleswig-Holstein 25541, Germany
  • GSK Investigational Site
    Flensburg, Schleswig-Holstein 24937, Germany
  • GSK Investigational Site
    Gluecksburg, Schleswig-Holstein 24960, Germany
  • GSK Investigational Site
    Husum, Schleswig-Holstein 25813, Germany
  • GSK Investigational Site
    Neumuenster, Schleswig-Holstein 24534, Germany
  • GSK Investigational Site
    Neuhaus am Rennweg, Thueringen 98724, Germany
  • GSK Investigational Site
    Rotterdam, 3015 GE, Netherlands
08

References and documents

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 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00127010
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 5, 2005
Start date
Nov 2005
Completion
Jun 2006
Last update
Sep 26, 2016

Study contacts

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

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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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Studies of the drug tested here: Measles-Mumps-Rubella Vaccine

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