ClinicalTrials.gg
CompletedNCT00126997Updated Sep 21, 2016

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

A Phase 4 interventional study of Measles, Mumps, Rubella and Chickenpox (live vaccine) in Mumps, Rubella and Measles, sponsored by GlaxoSmithKline. Completed at 54 sites in 4 countries. Open to participants aged 11 Months to 21 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-21.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
1,439
Allocation
Randomized
Ages
11 Months to 21 Months
Sex
All
01

Study summary

This is a study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals live attenuated measles-mumps-rubella-varicella vaccine given to healthy children in their second year of life.

02

Conditions studied

  • Mumps
  • Rubella
  • Measles
  • Varicella

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 1,439 is above 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.

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 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
1,439 participants (actual)

Interventions

  • BiologicalMeasles, 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

54 sites
  • GSK Investigational Site
    Espoo, 02100, Finland
  • GSK Investigational Site
    Lahti, 15140, Finland
  • GSK Investigational Site
    Oulu, 90100, Finland
  • GSK Investigational Site
    Pori, 28120, Finland
  • GSK Investigational Site
    Tampere, 33200, Finland
  • GSK Investigational Site
    Turku, 20520, Finland
  • GSK Investigational Site
    Vantaa, 01300, Finland
  • GSK Investigational Site
    Bayreuth, Bayern 95444, Germany
  • GSK Investigational Site
    Bindlach, Bayern 95463, Germany
  • GSK Investigational Site
    Bobingen, Bayern 86399, Germany
  • GSK Investigational Site
    Cham, Bayern 93413, Germany
  • GSK Investigational Site
    Kempten, Bayern 87435, Germany
  • GSK Investigational Site
    Muenchen, Bayern 81241, Germany
  • GSK Investigational Site
    Muenchen, Bayern 81735, Germany
  • GSK Investigational Site
    Noerdlingen, Bayern 86720, Germany
  • GSK Investigational Site
    Nuernberg, Bayern 90473, Germany
  • GSK Investigational Site
    Olching, Bayern 82140, Germany
  • GSK Investigational Site
    Tegernsee, Bayern 83684, Germany
  • GSK Investigational Site
    Tutzing, Bayern 82327, Germany
  • GSK Investigational Site
    Veitshoechheim, Bayern 97209, Germany
  • GSK Investigational Site
    Eschwege, Hessen 37269, Germany
  • GSK Investigational Site
    Frankfurt, Hessen 60389, Germany
  • GSK Investigational Site
    Fulda, Hessen 36037, Germany
  • GSK Investigational Site
    Nidderau, Hessen 61130, Germany
  • GSK Investigational Site
    Wiesbaden, Hessen 65205, 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
    Dortmund, Nordrhein-Westfalen 44329, Germany
  • GSK Investigational Site
    Espelkamp, Nordrhein-Westfalen 32339, Germany
  • GSK Investigational Site
    Goch, Nordrhein-Westfalen 47574, Germany
  • GSK Investigational Site
    Guetersloh, Nordrhein-Westfalen 33332, Germany
  • GSK Investigational Site
    Hille, Nordrhein-Westfalen 32479, Germany
  • GSK Investigational Site
    Kirchlengern, Nordrhein-Westfalen 32278, 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
    Moenchengladbach, Nordrhein-Westfalen 41061, Germany
  • GSK Investigational Site
    Moenchengladbach, Nordrhein-Westfalen 41236, Germany
  • GSK Investigational Site
    Muenster, Nordrhein-Westfalen 48159, Germany
  • GSK Investigational Site
    Wesseling, Nordrhein-Westfalen 50389, Germany
  • GSK Investigational Site
    Willich, Nordrhein-Westfalen 47877, Germany
  • GSK Investigational Site
    Arta, 471 00, Greece
  • GSK Investigational Site
    Athens, 11527, Greece
  • GSK Investigational Site
    Komotini, 69100, Greece
  • GSK Investigational Site
    Rhodes, 851 00, Greece
  • GSK Investigational Site
    Thessaloniki, 54636, Greece
  • GSK Investigational Site
    Bydgoszcz, 85-021, Poland
  • GSK Investigational Site
    Krakow, 31-202, Poland
  • GSK Investigational Site
    Poznan, 61-709, Poland
  • GSK Investigational Site
    Siemianowice Slaskie, 41-103, Poland
  • GSK Investigational Site
    Trzebnica, 55-100, Poland
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

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2005, a primary completion of Nov 2005 and a completion of Nov 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2005
First posted
Aug 5, 2005
Start
May 2005
Primary completionActual
Nov 2005
CompletionActual
Nov 2005
Last update
Sep 21, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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
NCT00126997
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 5, 2005
Start date
May 2005
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Sep 21, 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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