Last updated: 11/04/2018 00:39:47
A phase III, randomised, controlled study to evaluate the immunogenicity and safety of three production lots of GlaxoSmithKline Biologicals’ combined measles-mumps-rubella-varicella (MeMuRu-OKA) candidate vaccine given on a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GlaxoSmithKline Biologicals’ measles-mumps-rubella vaccine (Priorix®) and varicella vaccine (Varilrix®).
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: A phase III, randomised, controlled study to evaluate the immunogenicity and safety of three production lots of GlaxoSmithKline Biologicals’ combined measles-mumps-rubella-varicella (MeMuRu-OKA) candidate vaccine given on a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GlaxoSmithKline Biologicals’ measles-mumps-rubella vaccine (Priorix®) and varicella vaccine (Varilrix®).
Trial description: A phase III, randomised, controlled study to evaluate the immunogenicity and safety of three production lots of GlaxoSmithKline Biologicals’ combined measles-mumps-rubella-varicella (MeMuRu-OKA) candidate vaccine given on a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GlaxoSmithKline Biologicals’ measles-mumps-rubella vaccine (Priorix®) and varicella vaccine (Varilrix®).
Primary purpose:
Not applicable
Trial design:
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Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
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Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
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Clinical publications:
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Medical condition
Measles-Mumps-Rubella-Varicella Vaccine
Product
SB208133, SB208136, SB209762
Collaborators
Not applicable
Study date(s)
July 2003 to January 2004
Type
Not applicable
Phase
2/3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
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
Not applicable
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
2004-09-01
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
Not applicable
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