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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: Comparator: V710

Biological: Comparator: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00822757

V710-004

2007_531

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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