NCT01391546

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

An Open-label, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of ZOSTAVAX When Administered by Intramuscular Route or Subcutaneous Route to Subjects of 50 Years of Age and Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	ZOSTAVAX	1 dose 0.65 mL

Timeline

• Start date: 2011-06-20
• Primary completion: 2012-10-15
• Completion: 2012-10-15
• First posted: 2011-07-12
• Last updated: 2019-01-09
• Results posted: 2017-11-20

Regulatory

• FDA-regulated drug study