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

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

Completed

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Key information

Conditions

Staphylococcal Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Staphylococcal Infections

Age range

20 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V710

Biological

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

Placebo

Biological

Saline placebo (0.5 ml) single injection on Day 1

Primary outcomes

Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Aug 15, 2008
Registry last updated: Dec 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed