Last updated: 11/03/2018 00:27:23
Immunogenicity and safety of combined vaccine to prevent measles, mumps, rubella and chickenpox diseases
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
1439
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Mumps, Rubella, Measles, Varicella
Product
SB208133, SB208136, SB209762
Collaborators
Not applicable
Study date(s)
May 2005 to November 2005
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
11 - 21 months
Accepts healthy volunteers
Yes
- 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.
- 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
Inclusion and exclusion criteria
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
Trial location(s)
Location
GSK Investigational Site
Kirchlengern, Nordrhein-Westfalen, Germany, 32278
Status
Study Complete
Location
GSK Investigational Site
Minden, Nordrhein-Westfalen, Germany, 32427
Status
Study Complete
Location
GSK Investigational Site
Guetersloh, Nordrhein-Westfalen, Germany, 33332
Status
Study Complete
Location
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47798
Status
Study Complete
Location
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44329
Status
Study Complete
Location
GSK Investigational Site
Veitshoechheim, Bayern, Germany, 97209
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41236
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549
Status
Study Complete
Location
GSK Investigational Site
Wesseling, Nordrhein-Westfalen, Germany, 50389
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
Status
Study Complete
Location
GSK Investigational Site
Salzgitter, Niedersachsen, Germany, 38226
Status
Study Complete
Location
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41061
Status
Study Complete
Location
GSK Investigational Site
Hille, Nordrhein-Westfalen, Germany, 32479
Status
Study Complete
Location
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
Status
Study Complete
Location
GSK Investigational Site
Espelkamp, Nordrhein-Westfalen, Germany, 32339
Status
Study Complete
Location
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65205
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44866
Status
Study Complete
Location
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48159
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-22-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website