Chickenpox Clinical Trial
Official title:
Safety and Immunogenicity Study of 2 Formulations of GSK Biologicals' Varicella Vaccines Given as a 2-dose Course in the Second Year of Life.
The purpose of this study is to evaluate the safety and immunogenicity of 2 formulations of GSK Biologicals' varicella vaccines given as a 2-dose course in the second year of life.
GSK Biologicals has removed human serum albumin (a stabilizer) from its varicella vaccine to
minimize as much as possible the use of animal or human-derived products in the production of
vaccines. The study is intended to provide information on the safety and immunogenicity of
GlaxoSmithKline (GSK) Biologicals' candidate varicella vaccine formulated without human serum
albumin (HSA) in contrast to Varilrix™ (GSK) which contains HSA when both are used in a
two-dose schedule, with the first and second doses given approximately 42 days apart in the
second year of life.
The immunogenicity sub-cohort will be comprised of approximately 400 subjects, representing
approximately 100 subjects enrolled in each of the participating countries.
Rationale for amendment 1: Sites in the UK can perform home visits. For subjects
participating through home visits, the subject's parent(s) / Legally Acceptable
Representative(s) [LAR(s)] will be requested to sign a Recruitment/Randomisation agreement to
provide personal information and to agree to have their child randomised before providing
written consent to participate in the study (to be provided at the 1st home visit).
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