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

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Single Dose of the Lyophilized Formulation of Merck Staphylococcus Aureus Vaccine (V710) in Healthy Adults

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.

Inclusion Criteria:

• 18 to 80 years of age
• Good physical health based upon medical history and physical examination
• Willing and able to participate in the entire study duration
• Female subject with a negative urine pregnancy test immediately prior to study vaccination

Exclusion Criteria:

• Chronic skin infections or a chronic skin condition (e.g. psoriasis)
• Serious S. aureus infection in the last 12 months
• Allergy to aluminum-containing substance taken in the body or to any other vaccine component
• Oral temperature equal to or greater than 100.4ºF (38.0ºC), within the past 2 days
• Participation in a prior V710 vaccine clinical study
• Participation in any other clinical study in the past 4 weeks, or during the 3-month study duration