Status:
COMPLETED
Immunogenicity/Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA): Using Two Different Administration Routes
Lead Sponsor:
GlaxoSmithKline
Conditions:
Measles
Mumps
Eligibility:
All Genders
11-22 years
Phase:
PHASE3
Brief Summary
This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered subcutaneously or using an alternative administration route.
Eligibility Criteria
Inclusion
- Children must be healthy and have a birth weight \> 2000 g to participate
Exclusion
- confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chronical administration of salicylates, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
- Children from pregnant mothers who have a negative history of chickenpox are also excluded from the study.
- Children must have received one dose (but not more) of MMR and of varicella at least 6 weeks before entering the study. They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days.
- Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol within 30 days before vaccination.
- Children must not have had measles, mumps, rubella or varicella/zoster, or have been exposed to those diseases within 30 days prior to study start.
- New-born infants (\< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00351923
Start Date
March 1 2006
End Date
December 1 2006
Last Update
October 13 2008
Active Locations (20)
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1
GSK Investigational Site
Bönnigheim, Baden-Wurttemberg, Germany, 74357
2
GSK Investigational Site
Bretten, Baden-Wurttemberg, Germany, 75015
3
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, Germany, 77955
4
GSK Investigational Site
Karlsruhe, Baden-Wurttemberg, Germany, 76189