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: August 9, 2013
Last verified: August 2013
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
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: August 9, 2013
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 September 30, 2014