Trial Outcomes & Findings for Immunogenicity Study of the Japanese Encephalitis Vaccine IC51 (NCT NCT00604708)
NCT ID: NCT00604708
Last Updated: 2024-03-21
Results Overview
SCR: anti-JEV neutralizing antibody titer ≥1:10
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
867 participants
Primary outcome timeframe
Day 56
Results posted on
2024-03-21
Participant Flow
Participant milestones
| Measure |
IC51
IC51
|
JE-VAX
JE-VAX
|
|---|---|---|
|
Overall Study
STARTED
|
430
|
437
|
|
Overall Study
COMPLETED
|
399
|
397
|
|
Overall Study
NOT COMPLETED
|
31
|
40
|
Reasons for withdrawal
| Measure |
IC51
IC51
|
JE-VAX
JE-VAX
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
10
|
|
Overall Study
Protocol Violation
|
2
|
8
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
administrative reasons
|
9
|
11
|
|
Overall Study
Adverse Event
|
6
|
6
|
Baseline Characteristics
Immunogenicity Study of the Japanese Encephalitis Vaccine IC51
Baseline characteristics by cohort
| Measure |
IC51
n=430 Participants
IC51
|
JE-VAX
n=437 Participants
JE-VAX
|
Total
n=867 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
41.3 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
267 participants
n=5 Participants
|
258 participants
n=7 Participants
|
525 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
161 participants
n=5 Participants
|
177 participants
n=7 Participants
|
338 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
100 participants
n=5 Participants
|
103 participants
n=7 Participants
|
203 participants
n=5 Participants
|
|
Region of Enrollment
North America
|
330 participants
n=5 Participants
|
334 participants
n=7 Participants
|
664 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 56Population: Per Protocol Population: all randomized subjects without any protocol deviations as defined in the Statistical Analysis Plan
SCR: anti-JEV neutralizing antibody titer ≥1:10
Outcome measures
| Measure |
IC51
n=365 Participants
IC51
|
JE-VAX
n=370 Participants
JE-VAX
|
|---|---|---|
|
SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56
|
96.4 percentage of participants
|
93.6 percentage of participants
|
PRIMARY outcome
Timeframe: Day 56Population: PP Population: All randomized subjects without any major protocol deviations as assessed during a Data Review Meeting. Subjects who were randomized incorrectly or took the wrong study medications were also excluded.
GMT: geometric mean of PRNT50
Outcome measures
| Measure |
IC51
n=361 Participants
IC51
|
JE-VAX
n=364 Participants
JE-VAX
|
|---|---|---|
|
GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56
|
243.6 titers
Standard Deviation 1163.1
|
102 titers
Standard Deviation 221
|
SECONDARY outcome
Timeframe: until Day 56Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 28Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 56Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 56Outcome measures
Outcome data not reported
Adverse Events
IC51
Serious events: 1 serious events
Other events: 217 other events
Deaths: 0 deaths
JE-VAX
Serious events: 0 serious events
Other events: 213 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IC51
n=428 participants at risk
IC51
|
JE-VAX
n=435 participants at risk
JE-VAX
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.23%
1/428 • Number of events 1
numbers provided for safety population (N= 863)
|
0.00%
0/435
numbers provided for safety population (N= 863)
|
Other adverse events
| Measure |
IC51
n=428 participants at risk
IC51
|
JE-VAX
n=435 participants at risk
JE-VAX
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.8%
29/428
numbers provided for safety population (N= 863)
|
9.0%
39/435
numbers provided for safety population (N= 863)
|
|
General disorders
Fatigue
|
12.6%
54/428
numbers provided for safety population (N= 863)
|
11.0%
48/435
numbers provided for safety population (N= 863)
|
|
General disorders
Influenza like Ilness
|
12.6%
54/428
numbers provided for safety population (N= 863)
|
12.6%
55/435
numbers provided for safety population (N= 863)
|
|
General disorders
Pyrexia
|
5.6%
24/428
numbers provided for safety population (N= 863)
|
4.8%
21/435
numbers provided for safety population (N= 863)
|
|
Infections and infestations
Nasopharyngitis
|
6.1%
26/428
numbers provided for safety population (N= 863)
|
7.6%
33/435
numbers provided for safety population (N= 863)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.6%
88/428
numbers provided for safety population (N= 863)
|
15.9%
69/435
numbers provided for safety population (N= 863)
|
|
Nervous system disorders
Headache
|
26.4%
113/428
numbers provided for safety population (N= 863)
|
28.7%
125/435
numbers provided for safety population (N= 863)
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
7/428
numbers provided for safety population (N= 863)
|
2.1%
9/435
numbers provided for safety population (N= 863)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
10/428
numbers provided for safety population (N= 863)
|
2.5%
11/435
numbers provided for safety population (N= 863)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
2.8%
12/428
numbers provided for safety population (N= 863)
|
1.1%
5/435
numbers provided for safety population (N= 863)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER