Status:
COMPLETED
Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Rubella
Varicella
Eligibility:
All Genders
12-18 years
Phase:
PHASE3
Brief Summary
Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared...
Eligibility Criteria
Inclusion
- Written informed consent from the parents/guardians of the child before participating in the long-term follow-up.
- Subjects must have received their complete vaccination course according to the group allocation (i.e. subjects must have received either two doses of MMRV combined vaccine, or two doses of Priorix vaccine and one dose of Varilrix vaccine as separate injections in the primary vaccination study.
- Subjects were aged between 12 to 18 months of age at the time of the first vaccination in the primary study.
Exclusion
- Subjects must not have received an additional dose of measles, mumps, rubella or varicella containing vaccines.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
398 Patients enrolled
Trial Details
Trial ID
NCT00406211
Start Date
July 1 2004
End Date
December 1 2004
Last Update
September 15 2016
Active Locations (41)
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1
GSK Investigational Site
Klagenfurt, Austria, A-9020
2
GSK Investigational Site
Neufeld/Leitha, Austria, A 2491
3
GSK Investigational Site
Salzburg, Austria, A-5020
4
GSK Investigational Site
Villach, Austria, A-9500