ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)

Summary

The purpose of the study is to evaluate the general safety of ZOSTAVAX™ in subjects 60 years of age or older as required by the FDA.

Timeline

Start

2007-09

Primary completion

2009-01

Completion

2009-01

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper indicating no statistically significant difference between groups, meeting the pre-specified success criterion. PMID 22048110 ↗

Publications

• Results Murray AV, Reisinger KS, Kerzner B, Stek JE, Sausser TA, Xu J, Wang WW, Chan IS, Annunziato PW, Parrino J. Safety and tolerability of zoster vaccine in adults >/=60 years old. Hum Vaccin. 2011 Nov;7(11):1130-6. doi: 10.4161/hv.7.11.17982. Epub 2011 Nov 1.

Drugs

Indications