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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00735839
First Posted: August 15, 2008
Last Update Posted: December 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
August 13, 2008
August 15, 2008
May 23, 2012
June 26, 2012
December 21, 2015
March 2008
June 2008   (Final data collection date for primary outcome measure)
  • 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.
Change in Antibody level from baseline as measured at 5 predefined time points. [ Time Frame: Time Frame: 84 Days ]
Complete list of historical versions of study NCT00735839 on ClinicalTrials.gov Archive Site
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V710 Clinical Study in Healthy Male Japanese Subjects (V710-006) (COMPLETED)
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
This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Staphylococcal Infection
  • Biological: V710
    V710 vaccination (60 mcg, 0.5 ml) single injection on Day 1
  • Biological: Placebo
    Saline placebo (0.5 ml) single injection on Day 1
  • Experimental: V710
    V710 vaccination (60 mcg) single dose on Day 1
    Intervention: Biological: V710
  • Placebo Comparator: Placebo
    Placebo single dose on Day 1
    Intervention: Biological: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2008
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
20 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00735839
V710-006
2008_017
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP