Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004)

Phase 1 Completed 51 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindPrevention

Summary

This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to provide necessary safety and immunogenicity data for the lyophilized formulation of V710 prior to its subsequent evaluation in patients at risk for developing serious S. aureus infections.

Timeline

Start: 2007-08
Primary completion: 2007-10
Completion: 2007-12

Publications

Results Harro CD, Betts RF, Hartzel JS, Onorato MT, Lipka J, Smugar SS, Kartsonis NA. The immunogenicity and safety of different formulations of a novel Staphylococcus aureus vaccine (V710): results of two Phase I studies. Vaccine. 2012 Feb 21;30(9):1729-36. doi: 10.1016/j.vaccine.2011.12.045. Epub 2011 Dec 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	V710	Vaccine	60 ug	Intramuscular

Indications

No indication recorded.