NCT00735839

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

June 26, 2012

Completed
Last Updated

December 21, 2015

Status Verified

December 1, 2015

Enrollment Period

3 months

First QC Date

August 13, 2008

Results QC Date

May 23, 2012

Last Update Submit

December 18, 2015

Conditions

Staphylococcal Infection

Outcome Measures

Primary Outcomes (2)

  • Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level

    Geometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers.

    Baseline (Day 1) to Day 14 postvaccination

  • Number of Participants With Vaccine-related Serious Adverse Experiences

    Vaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related.

    Baseline (Day 1) to Day 84 postvaccination

Study Arms (2)

V710

EXPERIMENTAL

V710 vaccination (60 mcg) single dose on Day 1

Biological: V710

Placebo

PLACEBO COMPARATOR

Placebo single dose on Day 1

Biological: Placebo

Interventions

V710BIOLOGICAL

V710 vaccination (60 mcg, 0.5 ml) single injection on Day 1

V710
PlaceboBIOLOGICAL

Saline placebo (0.5 ml) single injection on Day 1

Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Generally Good Physical Health

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

V710 vaccine

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 15, 2008

Study Start

March 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

December 21, 2015

Results First Posted

June 26, 2012

Record last verified: 2015-12