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

NCT ID: NCT00735839

Last Updated: 2015-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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Conditions

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Staphylococcal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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V710

V710 vaccination (60 mcg) single dose on Day 1

Group Type EXPERIMENTAL

V710

Intervention Type BIOLOGICAL

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

Placebo

Placebo single dose on Day 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Saline placebo (0.5 ml) single injection on Day 1

Interventions

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V710

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

Intervention Type BIOLOGICAL

Placebo

Saline placebo (0.5 ml) single injection on Day 1

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2008_017

Identifier Type: -

Identifier Source: secondary_id

V710-006

Identifier Type: -

Identifier Source: org_study_id