Staphylococcal Infection
Conditions
Brief summary
This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.
Interventions
BIOLOGICALV710
V710 vaccination (60 mcg, 0.5 ml) single injection on Day 1
BIOLOGICALPlacebo
Saline placebo (0.5 ml) single injection on Day 1
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level | Baseline (Day 1) to Day 14 postvaccination | 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 | Baseline (Day 1) to Day 84 postvaccination | Vaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| V710 V710 vaccination (60 mcg) single dose on Day 1 | 30 |
| Placebo Placebo single dose on Day 1 | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | V710 | Placebo | Total |
|---|---|---|---|
| Age, Customized 20-74 years | 30 participants | 10 participants | 40 participants |
| Age, Customized <20 years | 0 participants | 0 participants | 0 participants |
| Age, Customized >74 years | 0 participants | 0 participants | 0 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 10 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 30 | 2 / 10 |
| serious Total, serious adverse events | 0 / 30 | 0 / 10 |
Outcome results
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.
Time frame: Baseline (Day 1) to Day 14 postvaccination
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V710 | Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level | 4.4 Ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level | 0.9 Ratio |
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.
Time frame: Baseline (Day 1) to Day 84 postvaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V710 | Number of Participants With Vaccine-related Serious Adverse Experiences | 0 Participants |
| Placebo | Number of Participants With Vaccine-related Serious Adverse Experiences | 0 Participants |