Last updated: 11/03/2018 00:08:23
Immunogenicity and safety of a 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, randomized study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ measles-mumps-rubella-varicella candidate vaccine given to healthy children during the second year of life
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Measles, Rubella, Mumps, Varicella
Product
SB208136, SB209762
Collaborators
Not applicable
Study date(s)
November 2005 to June 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
11 - 13 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
Herford, Nordrhein-Westfalen, Germany, 32049
Status
Study Complete
Location
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
Status
Study Complete
Location
GSK Investigational Site
Minden, Nordrhein-Westfalen, Germany, 32427
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44866
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
Status
Study Complete
Showing 1 - 6 of 48 Results
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
2006-09-06
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
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