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Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Participants Aged From 50 Years Old (V211-045)

Merck Sharp & Dohme LLC · 2011
ClinicalTrials.gov · Datasets · License: Public Domain · 2011
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herpes-zoster
PRIMARY OBJECTIVES Two co-primary objectives are: * To demonstrate that the immunogenicity of ZOSTAVAX administered by intramuscular route (IM) is non-inferior to ZOSTAVAX administered by subcutaneous route (SC) * To demonstrate that ZOSTAVAX administered by IM route induces an acceptable fold-rise of varicella zoster virus (VZV) antibody titre from pre to 4-week post-vaccination SECONDARY OBJECTIVES Immunogenicity objectives * To evaluate the immunogenicity as measured by VZV antibody titre at 4 weeks following ZOSTAVAX administered by IM or SC route * To evaluate the immune response as measured by a second assay, the VZV Interferon gamma Enzyme-linked immunospot (ELISPOT) at 4 weeks following ZOSTAVAX administered by IM or SC route Safety objective \- To describe the safety profile of ZOSTAVAX administered by IM or SC route
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