Evaluation of the Safety and Tolerability of a Higher Potency Dose of an Investigational Vaccine Among Adults 50 Years of Age and Older (V211-009)

Phase 3 Completed 695 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindPrevention

Summary

This study compared the safety and tolerability profile of a higher potency investigational vaccine to that of the investigational vaccine at a lower potency dose.

Timeline

Start: 2003-10
Primary completion: 2004-06
Completion: 2004-06

Publications

Background Tyring SK, Diaz-Mitoma F, Padget LG, Nunez M, Poland G, Cassidy WM, Bundick ND, Li J, Chan IS, Stek JE, Annunziato PW; Protocol 009 Study Group. Safety and tolerability of a high-potency zoster vaccine in adults >/= 50 or years of age. Vaccine. 2007 Feb 26;25(10):1877-83. doi: 10.1016/j.vaccine.2006.10.027. Epub 2006 Oct 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Varivax	Vaccine	58000 unknown	Subcutaneous
Subject	Varivax	Vaccine	207000 unknown	Subcutaneous

Indications

No indication recorded.