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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00735839
First received: August 13, 2008
Last updated: November 13, 2014
Last verified: November 2014

August 13, 2008
November 13, 2014
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00735839 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Not Provided

*   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
Male
20 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00735839
V710-006, 2008_017
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2014

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