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

Phase 1CompletedNCT00735839

Merck Sharp & Dohme LLC40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Staphylococcal Infection

Interventions

V710BIOLOGICAL

V710 vaccination (60 mcg, 0.5 ml) single injection on Day 1

PlaceboBIOLOGICAL

Saline placebo (0.5 ml) single injection on Day 1

Eligibility

Sex: MALEMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline (Day 1) to Day 84 postvaccination

Data from ClinicalTrials.gov

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