Status:
COMPLETED
Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™
Lead Sponsor:
GlaxoSmithKline
Conditions:
Varicella
Rubella
Eligibility:
All Genders
15-6 years
Phase:
PHASE2
Brief Summary
As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the ...
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 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.
- Children must not have been vaccinated against varicella.
- 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 :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
446 Patients enrolled
Trial Details
Trial ID
NCT00353288
Start Date
March 1 2006
End Date
November 1 2006
Last Update
October 7 2016
Active Locations (39)
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1
GSK Investigational Site
Ancenis, France, 44150
2
GSK Investigational Site
Boulogne, France, 92100
3
GSK Investigational Site
Dax, France, 40100
4
GSK Investigational Site
Draguignan, France, 83300