Status:
COMPLETED
Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™
Lead Sponsor:
GlaxoSmithKline
Conditions:
Mumps
Rubella
Eligibility:
All Genders
15-6 years
Phase:
PHASE2
Brief Summary
Since measles-mumps-rubella (MMR) and varicella vaccinations are established as routine childhood practice and often co-administered during the second year of life, a combined measles-mumps-rubella-va...
Eligibility Criteria
Inclusion
- Children must be healthy to participate
Exclusion
- immunosuppressive (including HIV) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to MMR vaccine, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors. Children must have received one dose (but not more) of MMR and of varicella vaccine 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, 30 days before until 56 days after vaccination. They must not have had measles, mumps, rubella or varicella, 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 :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00352898
Start Date
April 1 2006
End Date
November 1 2006
Last Update
October 7 2016
Active Locations (6)
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1
GSK Investigational Site
Edmonton, Alberta, Canada, T5N 4A3
2
GSK Investigational Site
Vancouver, British Columbia, Canada, V6H 3N1
3
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
4
GSK Investigational Site
Enna, Sicily, Italy, 94015