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

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ClinicalTrials.gov Identifier: NCT00735839
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : June 26, 2012
Last Update Posted : December 21, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Staphylococcal Infection Biological: V710 Biological: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official 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
Study Start Date : March 2008
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735839

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00735839     History of Changes
Other Study ID Numbers: V710-006
First Posted: August 15, 2008    Key Record Dates
Results First Posted: June 26, 2012
Last Update Posted: December 21, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections