Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)

Summary

Primary objective: To demonstrate whether or not ZOSTAVAX® at minimum release specification approaching expiry potency elicits an acceptable Varicella-Zoster Virus (VZV) antibody fold rise (measured by glycoprotein Enzyme Linked ImmunoSorbent Assay \[gpELISA\]) from pre-vaccination to 4 weeks post-vaccination. Secondary objectives: To describe the safety profile of ZOSTAVAX® at minimum release specification approaching expiry potency.

Timeline

Start

2008-05-14

Primary completion

2008-06-25

Completion

2008-06-25

Publications

• Arnou R, Fiquet A, Thomas S, Sadorge C. Immunogenicity and safety of ZOSTAVAX((R)) approaching expiry potency in individuals aged >/=50 years. Hum Vaccin. 2011 Oct;7(10):1060-5. doi: 10.4161/hv.7.10.16480. Epub 2011 Oct 1.

Drugs

Indications