Trial Outcomes & Findings for Safety and Efficacy of CJ-50300 in Healthy Volunteers (NCT NCT00607243)
NCT ID: NCT00607243
Last Updated: 2013-07-09
Results Overview
The "take reaction"was defined as a vesicular or pustular lesion or an area of definite palpable induration or congestion surrounding a central lesion (a crust or ulcer) occurring at the vaccination site at any of post-vaccination days (PVDs) 6-8. The vaccination site was photographed, and measures were taken.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
123 participants
Primary outcome timeframe
7-9 day
Results posted on
2013-07-09
Participant Flow
Participant milestones
| Measure |
Conventional-dose Group
Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
|
Low-dose Group
Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
|
|---|---|---|
|
Initial Post-vaccination Period
STARTED
|
82
|
41
|
|
Initial Post-vaccination Period
COMPLETED
|
82
|
41
|
|
Initial Post-vaccination Period
NOT COMPLETED
|
0
|
0
|
|
Telephone Safety Assessment Period
STARTED
|
82
|
41
|
|
Telephone Safety Assessment Period
COMPLETED
|
77
|
39
|
|
Telephone Safety Assessment Period
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of CJ-50300 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Conventional-dose Group
n=82 Participants
Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
|
Low-dose Group
n=41 Participants
Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
82 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
23.9 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
24.3 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
24.0 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
82 participants
n=5 Participants
|
41 participants
n=7 Participants
|
123 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7-9 dayThe "take reaction"was defined as a vesicular or pustular lesion or an area of definite palpable induration or congestion surrounding a central lesion (a crust or ulcer) occurring at the vaccination site at any of post-vaccination days (PVDs) 6-8. The vaccination site was photographed, and measures were taken.
Outcome measures
| Measure |
Conventional-dose Group
n=82 Participants
Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
|
Low-dose Group
n=41 Participants
Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
|
|---|---|---|
|
Cutaneous Take Reaction
|
81 participants
Interval 0.93 to 0.99
|
41 participants
Interval 0.9 to 1.0
|
PRIMARY outcome
Timeframe: 0-28 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 or 28 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 or 28 daysOutcome measures
Outcome data not reported
Adverse Events
Conventional-dose Group
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Low-dose Group
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Conventional-dose Group
n=82 participants at risk
Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
|
Low-dose Group
n=41 participants at risk
Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
|
|---|---|---|
|
Infections and infestations
Chill
|
9.8%
8/82 • 28 days, 3 months, 6 months
In the Conventional-dose Group, all 82 finished the 28 day follow up, 80 were available for 3 months, and 77 were available for the 6 months safety assessment. In the Low-dose Group, all 41 finished the 28 day follow up, 40 were available for 3 months, and 39 were available for the 6 months safety assessment.
|
12.2%
5/41 • 28 days, 3 months, 6 months
In the Conventional-dose Group, all 82 finished the 28 day follow up, 80 were available for 3 months, and 77 were available for the 6 months safety assessment. In the Low-dose Group, all 41 finished the 28 day follow up, 40 were available for 3 months, and 39 were available for the 6 months safety assessment.
|
|
Infections and infestations
Myalgia
|
8.5%
7/82 • 28 days, 3 months, 6 months
In the Conventional-dose Group, all 82 finished the 28 day follow up, 80 were available for 3 months, and 77 were available for the 6 months safety assessment. In the Low-dose Group, all 41 finished the 28 day follow up, 40 were available for 3 months, and 39 were available for the 6 months safety assessment.
|
19.5%
8/41 • 28 days, 3 months, 6 months
In the Conventional-dose Group, all 82 finished the 28 day follow up, 80 were available for 3 months, and 77 were available for the 6 months safety assessment. In the Low-dose Group, all 41 finished the 28 day follow up, 40 were available for 3 months, and 39 were available for the 6 months safety assessment.
|
|
Infections and infestations
Fatigue
|
19.5%
16/82 • 28 days, 3 months, 6 months
In the Conventional-dose Group, all 82 finished the 28 day follow up, 80 were available for 3 months, and 77 were available for the 6 months safety assessment. In the Low-dose Group, all 41 finished the 28 day follow up, 40 were available for 3 months, and 39 were available for the 6 months safety assessment.
|
22.0%
9/41 • 28 days, 3 months, 6 months
In the Conventional-dose Group, all 82 finished the 28 day follow up, 80 were available for 3 months, and 77 were available for the 6 months safety assessment. In the Low-dose Group, all 41 finished the 28 day follow up, 40 were available for 3 months, and 39 were available for the 6 months safety assessment.
|
|
Infections and infestations
Headache
|
11.0%
9/82 • 28 days, 3 months, 6 months
In the Conventional-dose Group, all 82 finished the 28 day follow up, 80 were available for 3 months, and 77 were available for the 6 months safety assessment. In the Low-dose Group, all 41 finished the 28 day follow up, 40 were available for 3 months, and 39 were available for the 6 months safety assessment.
|
19.5%
8/41 • 28 days, 3 months, 6 months
In the Conventional-dose Group, all 82 finished the 28 day follow up, 80 were available for 3 months, and 77 were available for the 6 months safety assessment. In the Low-dose Group, all 41 finished the 28 day follow up, 40 were available for 3 months, and 39 were available for the 6 months safety assessment.
|
|
Infections and infestations
Pain at vaccination site
|
20.7%
17/82 • 28 days, 3 months, 6 months
In the Conventional-dose Group, all 82 finished the 28 day follow up, 80 were available for 3 months, and 77 were available for the 6 months safety assessment. In the Low-dose Group, all 41 finished the 28 day follow up, 40 were available for 3 months, and 39 were available for the 6 months safety assessment.
|
24.4%
10/41 • 28 days, 3 months, 6 months
In the Conventional-dose Group, all 82 finished the 28 day follow up, 80 were available for 3 months, and 77 were available for the 6 months safety assessment. In the Low-dose Group, all 41 finished the 28 day follow up, 40 were available for 3 months, and 39 were available for the 6 months safety assessment.
|
|
Infections and infestations
Axillary pain or lymphadenopathy
|
34.1%
28/82 • 28 days, 3 months, 6 months
In the Conventional-dose Group, all 82 finished the 28 day follow up, 80 were available for 3 months, and 77 were available for the 6 months safety assessment. In the Low-dose Group, all 41 finished the 28 day follow up, 40 were available for 3 months, and 39 were available for the 6 months safety assessment.
|
36.6%
15/41 • 28 days, 3 months, 6 months
In the Conventional-dose Group, all 82 finished the 28 day follow up, 80 were available for 3 months, and 77 were available for the 6 months safety assessment. In the Low-dose Group, all 41 finished the 28 day follow up, 40 were available for 3 months, and 39 were available for the 6 months safety assessment.
|
|
Infections and infestations
Satellite lesion
|
9.8%
8/82 • 28 days, 3 months, 6 months
In the Conventional-dose Group, all 82 finished the 28 day follow up, 80 were available for 3 months, and 77 were available for the 6 months safety assessment. In the Low-dose Group, all 41 finished the 28 day follow up, 40 were available for 3 months, and 39 were available for the 6 months safety assessment.
|
9.8%
4/41 • 28 days, 3 months, 6 months
In the Conventional-dose Group, all 82 finished the 28 day follow up, 80 were available for 3 months, and 77 were available for the 6 months safety assessment. In the Low-dose Group, all 41 finished the 28 day follow up, 40 were available for 3 months, and 39 were available for the 6 months safety assessment.
|
Additional Information
Myoung-don Oh, M.D.
Seoul National University Hospital
Phone: +82-2-2072-2945
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place