Trial Outcomes & Findings for V710 Clinical Study in Healthy Male Japanese Subjects (V710-006) (COMPLETED) (NCT NCT00735839)
NCT ID: NCT00735839
Last Updated: 2015-12-21
Results Overview
Geometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Baseline (Day 1) to Day 14 postvaccination
Results posted on
2015-12-21
Participant Flow
Participant milestones
| Measure |
V710
V710 vaccination (60 mcg) single dose on Day 1
|
Placebo
Placebo single dose on Day 1
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
10
|
|
Overall Study
COMPLETED
|
30
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
V710 Clinical Study in Healthy Male Japanese Subjects (V710-006) (COMPLETED)
Baseline characteristics by cohort
| Measure |
V710
n=30 Participants
V710 vaccination (60 mcg) single dose on Day 1
|
Placebo
n=10 Participants
Placebo single dose on Day 1
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<20 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
20-74 years
|
30 participants
n=5 Participants
|
10 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Age, Customized
>74 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Day 14 postvaccinationGeometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers.
Outcome measures
| Measure |
V710
n=30 Participants
V710 vaccination (60 mcg) single dose on Day 1
|
Placebo
n=10 Participants
Placebo single dose on Day 1
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level
|
4.4 Ratio
Interval 3.0 to 6.4
|
0.9 Ratio
Interval 0.8 to 1.0
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Day 84 postvaccinationVaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related.
Outcome measures
| Measure |
V710
n=30 Participants
V710 vaccination (60 mcg) single dose on Day 1
|
Placebo
n=10 Participants
Placebo single dose on Day 1
|
|---|---|---|
|
Number of Participants With Vaccine-related Serious Adverse Experiences
|
0 Participants
|
0 Participants
|
Adverse Events
V710
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
V710
n=30 participants at risk
V710 vaccination (60 mcg) single dose on Day 1
|
Placebo
n=10 participants at risk
Placebo single dose on Day 1
|
|---|---|---|
|
General disorders
Injection site erythema
|
3.3%
1/30 • Number of events 1 • Day 1 through Day 14 postvaccination
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 14 postvaccination
|
|
General disorders
Injection site pain
|
36.7%
11/30 • Number of events 11 • Day 1 through Day 14 postvaccination
|
0.00%
0/10 • Day 1 through Day 14 postvaccination
|
|
General disorders
Injection site swelling
|
6.7%
2/30 • Number of events 2 • Day 1 through Day 14 postvaccination
|
0.00%
0/10 • Day 1 through Day 14 postvaccination
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/30 • Day 1 through Day 14 postvaccination
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 14 postvaccination
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place