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An open-label, randomised, comparative, multicentre study of the immunogenicity and safety of ZOSTAVAX® when administered by intramuscular route or subcutaneous route to subjects ≥50 years of age

Update Il y a 4 ans
Reference: EUCTR2009-012458-19

Woman and Man

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Extract

Two co-primary objectives are: To demonstrate that ZOSTAVAX® administered by intramuscular (IM) route is non-inferior to ZOSTAVAX® administered by subcutaneous (SC) route in terms of 4-week post-vaccination antibody titres as measured by glycoprotein enzyme-linked immunosorbent assay (gpELISA) to varicella-zoster virus (VZV) in subjects ≥50 years of age. To demonstrate that ZOSTAVAX® administered by IM route induces an acceptable fold-rise of VZV antibody titres (gpELISA) from pre to 4-week post-vaccination in subjects ≥50 years of age.

Inclusion criteria

  • Not applicable as Prevention of herpes zoster ("zoster" or shingles) and herpes zoster-related post-herpetic neuralgia (PHN)

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