Immunogenicity and Safety of a 1-dose Regimen of a Zoster Vaccine Versus Different 2-dose Regimens in Participants ≥ 70 Years of Age. (V211-043)

Summary

Primary objective: Immunogenicity To demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a 0-1 month schedule or as a 0-3 month schedule in subjects ≥70 years of age as measured at 4 weeks post-vaccination Secondary objectives Immunogenicity * To summarise the VZV antibody titres at 4 weeks post-vaccination after a 1-dose regimen and 4 weeks post-vaccination after each dose of each 2-doses regimen of ZOSTAVAX®. * To compare the VZV antibody titres at 12 months after completion of a 1-dose regimen with the VZV antibody titres at 12 months after completion of each 2-doses regimen of ZOSTAVAX® * To summarise the VZV antibody titres at 24 and 36 months after completion of a 1-dose regimen and at 24 and 36 months after completion of each 2-doses regimen of ZOSTAVAX®

Timeline

Start

2007-10-26

Primary completion

2009-06-03

Completion

2009-06-03

Publications

• Vesikari T, Hardt R, Rumke HC, Icardi G, Montero J, Thomas S, Sadorge C, Fiquet A. Immunogenicity and safety of a live attenuated shingles (herpes zoster) vaccine (Zostavax(R)) in individuals aged >/= 70 years: a randomized study of a single dose vs. two different two-dose schedules. Hum Vaccin Immunother. 2013 Apr;9(4):858-64. doi: 10.4161/hv.23412. Epub 2013 Jan 14.

Drugs

Indications