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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
ClinicalTrials.gov Identifier:
NCT00735839
First received: August 13, 2008
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Staphylococcal Infection
 Biological: V710
Biological: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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.


Enrollment: 40
Study Start Date: March 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735839

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00735839     History of Changes
Other Study ID Numbers: V710-006, 2008_017
Study First Received: August 13, 2008
Results First Received: May 23, 2012
Last Updated: May 23, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on May 23, 2013