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

Staphylococcal Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735839
• Other study ID #: V710-006
• Secondary ID: 2008_017
• Status: Completed
• Phase: Phase 1
• First received: August 13, 2008
• Last updated: December 18, 2015
• Start date: March 2008
• Est. completion date: June 2008

Study information

• Verified date: December 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Staphylococcal Infection
• Staphylococcal Infections

Intervention

Biological:
• V710
V710 vaccination (60 mcg, 0.5 ml) single injection on Day 1
• Placebo
Saline placebo (0.5 ml) single injection on Day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes