Varicella Clinical Trial
Official title:
Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine
An observer-blind study to evaluate GlaxoSmithKline Biologicals' live attenuated varicella vaccine and GlaxoSmithKline Biologicals' combined measles-mumps-rubella-varicella vaccine in the prevention of varicella disease in children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
According to treatment group allocation, participants will receive study vaccines and be
followed for antibody titres and occurrence of varicella disease.
This study is conducted in 2 phases. Phase A includes the vaccination period and an
observation period for efficacy. The efficacy endpoints will be evaluated over at least two
years after vaccination. During this period, the immunogenicity endpoints will be evaluated
with respect to the immune response 43 days after vaccination and the persistence of
antibodies over two years to varicella (for all subjects) and to measles, mumps and rubella
(for a subset of subjects). Regarding the safety endpoints, SAEs (including any complicated
varicella cases if observed) will be assessed for all subjects during the whole Phase A
duration, whereas, solicited (local and general) and unsolicited adverse events will be
assessed in a subset of subjects within a 43-day period after vaccination.
Phase B is an extension of Phase A. It is a long-term follow-up until Year 10 to examine the
long-term efficacy of the study vaccines against clinical varicella disease as well as the
long-term persistence of antibodies to varicella (for all subjects) and to measles, mumps and
rubella (in a subset of subjects) after vaccination.
;
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