V710 Clinical Study in Healthy Male Japanese Subjects (V710-006) (COMPLETED)
This study has been completed.
Information provided by (Responsible Party):
First received: August 13, 2008
Last updated: August 9, 2013
Last verified: August 2013
This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.
|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:
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.
|Study Start Date:||March 2008|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
V710 vaccination (60 mcg) single dose on Day 1
V710 vaccination (60 mcg, 0.5 ml) single injection on Day 1
Placebo Comparator: Placebo
Placebo single dose on Day 1
Saline placebo (0.5 ml) single injection on Day 1
Contacts and Locations