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

Phase 1

Completed

• Conditions: Staphylococcal Infection
• Interventions: Biological: Placebo; Biological: V710

• Registration Number: NCT00735839
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-15
• Results First Submitted: 2012-05-23
• Results First Submitted QC: 2012-05-23
• Results First Posted: 2012-06-26
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-18
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Generally Good Physical Health

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo single dose on Day 1
V710	V710	V710 vaccination (60 mcg) single dose on Day 1

Primary Outcome Measures

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