V710 Clinical Study in Healthy Male Japanese Subjects (V710-006) (COMPLETED)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Single Dose of Merck S. Aureus Vaccine (V710) in Healthy Male Japanese Subjects

This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.

Study Overview

• Status: Completed
• Conditions: Staphylococcal Infection
• Intervention / Treatment: Biological: V710; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Generally Good Physical Health

Exclusion Criteria:

• Received V710 Vaccine, Any Other Investigational S. Aureus Vaccine, Or Investigational S. Aureus Antibodies Before
• Temperature Of Equal/Greater Than 100.4 Degrees F(38 Degrees C) Within The Past 48 Hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V710; V710 vaccination (60 mcg) single dose on Day 1	Biological: V710; V710 vaccination (60 mcg, 0.5 ml) single injection on Day 1
Placebo Comparator: Placebo; Placebo single dose on Day 1	Biological: Placebo; Saline placebo (0.5 ml) single injection on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level	Geometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers.	Baseline (Day 1) to Day 14 postvaccination
Number of Participants With Vaccine-related Serious Adverse Experiences	Vaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related.	Baseline (Day 1) to Day 84 postvaccination

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: August 13, 2008
• First Submitted That Met QC Criteria: August 13, 2008
• First Posted (Estimate): August 15, 2008

Study Record Updates

• Last Update Posted (Estimate): December 21, 2015
• Last Update Submitted That Met QC Criteria: December 18, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Staphylococcal Infections
• Other Study ID Numbers: V710-006; 2008_017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No