Trial Outcomes & Findings for Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51 (NCT NCT00595465)
NCT ID: NCT00595465
Last Updated: 2014-05-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
389 participants
Primary outcome timeframe
Day 56
Results posted on
2014-05-16
Participant Flow
Participant milestones
| Measure |
IC51 Batch IC51/07E/006A
|
IC51 Batch IC51/07E/007A
|
IC51 Batch IC51/07E/008A
|
|---|---|---|---|
|
Overall Study
STARTED
|
130
|
129
|
128
|
|
Overall Study
COMPLETED
|
124
|
125
|
121
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
7
|
Reasons for withdrawal
| Measure |
IC51 Batch IC51/07E/006A
|
IC51 Batch IC51/07E/007A
|
IC51 Batch IC51/07E/008A
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
3
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
|
Overall Study
administrative reason
|
0
|
0
|
1
|
Baseline Characteristics
Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51
Baseline characteristics by cohort
| Measure |
IC51 Batch IC51/07E/006A
n=130 Participants
|
IC51 Batch IC51/07E/007A
n=129 Participants
|
IC51 Batch IC51/07E/008A
n=128 Participants
|
Total
n=387 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
130 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
385 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
29.3 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
28.9 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
30.2 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
29.5 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
228 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
130 participants
n=5 Participants
|
129 participants
n=7 Participants
|
128 participants
n=5 Participants
|
387 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 56Population: Per Protocol Population (PP Population, N= 364): includes all subjects randomized who received at least one dose of study medication without any major protocol violations identified at the blind data review meeting.
Outcome measures
| Measure |
IC51 Batch IC51/07E/006A
n=124 Participants
|
IC51 Batch IC51/07E/007A
n=121 Participants
|
IC51 Batch IC51/07E/008A
n=119 Participants
|
|---|---|---|---|
|
Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody
|
160.8 titers
Standard Deviation 398.0
|
188.2 titers
Standard Deviation 410.2
|
168.4 titers
Standard Deviation 483.6
|
SECONDARY outcome
Timeframe: Day 56Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 56Outcome measures
Outcome data not reported
Adverse Events
IC51 Batch IC51/07E/006A
Serious events: 2 serious events
Other events: 64 other events
Deaths: 0 deaths
IC51 Batch IC51/07E/007A
Serious events: 1 serious events
Other events: 74 other events
Deaths: 0 deaths
IC51 Batch IC51/07E/008A
Serious events: 0 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IC51 Batch IC51/07E/006A
n=130 participants at risk
|
IC51 Batch IC51/07E/007A
n=129 participants at risk
|
IC51 Batch IC51/07E/008A
n=128 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/130
389 subjects were randomized, 2 of them were not treated
|
0.78%
1/129
389 subjects were randomized, 2 of them were not treated
|
0.00%
0/128
389 subjects were randomized, 2 of them were not treated
|
|
Infections and infestations
Tubo-Ovarian Abscess
|
0.77%
1/130
389 subjects were randomized, 2 of them were not treated
|
0.00%
0/129
389 subjects were randomized, 2 of them were not treated
|
0.00%
0/128
389 subjects were randomized, 2 of them were not treated
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.77%
1/130
389 subjects were randomized, 2 of them were not treated
|
0.00%
0/129
389 subjects were randomized, 2 of them were not treated
|
0.00%
0/128
389 subjects were randomized, 2 of them were not treated
|
Other adverse events
| Measure |
IC51 Batch IC51/07E/006A
n=130 participants at risk
|
IC51 Batch IC51/07E/007A
n=129 participants at risk
|
IC51 Batch IC51/07E/008A
n=128 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
3.1%
4/130
389 subjects were randomized, 2 of them were not treated
|
0.78%
1/129
389 subjects were randomized, 2 of them were not treated
|
0.78%
1/128
389 subjects were randomized, 2 of them were not treated
|
|
Ear and labyrinth disorders
Vertigo
|
0.77%
1/130
389 subjects were randomized, 2 of them were not treated
|
3.1%
4/129
389 subjects were randomized, 2 of them were not treated
|
0.78%
1/128
389 subjects were randomized, 2 of them were not treated
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/130
389 subjects were randomized, 2 of them were not treated
|
0.78%
1/129
389 subjects were randomized, 2 of them were not treated
|
2.3%
3/128
389 subjects were randomized, 2 of them were not treated
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/130
389 subjects were randomized, 2 of them were not treated
|
0.00%
0/129
389 subjects were randomized, 2 of them were not treated
|
2.3%
3/128
389 subjects were randomized, 2 of them were not treated
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
4/130
389 subjects were randomized, 2 of them were not treated
|
3.1%
4/129
389 subjects were randomized, 2 of them were not treated
|
2.3%
3/128
389 subjects were randomized, 2 of them were not treated
|
|
Gastrointestinal disorders
Nausea
|
9.2%
12/130
389 subjects were randomized, 2 of them were not treated
|
7.8%
10/129
389 subjects were randomized, 2 of them were not treated
|
7.0%
9/128
389 subjects were randomized, 2 of them were not treated
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
2/130
389 subjects were randomized, 2 of them were not treated
|
2.3%
3/129
389 subjects were randomized, 2 of them were not treated
|
3.1%
4/128
389 subjects were randomized, 2 of them were not treated
|
|
General disorders
Fatigue
|
13.1%
17/130
389 subjects were randomized, 2 of them were not treated
|
14.7%
19/129
389 subjects were randomized, 2 of them were not treated
|
10.9%
14/128
389 subjects were randomized, 2 of them were not treated
|
|
General disorders
Influenza Like Illness
|
14.6%
19/130
389 subjects were randomized, 2 of them were not treated
|
19.4%
25/129
389 subjects were randomized, 2 of them were not treated
|
19.5%
25/128
389 subjects were randomized, 2 of them were not treated
|
|
General disorders
Injection Site Haematoma
|
1.5%
2/130
389 subjects were randomized, 2 of them were not treated
|
3.1%
4/129
389 subjects were randomized, 2 of them were not treated
|
1.6%
2/128
389 subjects were randomized, 2 of them were not treated
|
|
General disorders
Injection Site Pain
|
3.1%
4/130
389 subjects were randomized, 2 of them were not treated
|
3.9%
5/129
389 subjects were randomized, 2 of them were not treated
|
0.78%
1/128
389 subjects were randomized, 2 of them were not treated
|
|
General disorders
Pyrexia
|
6.2%
8/130
389 subjects were randomized, 2 of them were not treated
|
2.3%
3/129
389 subjects were randomized, 2 of them were not treated
|
2.3%
3/128
389 subjects were randomized, 2 of them were not treated
|
|
Infections and infestations
Bronchitis
|
2.3%
3/130
389 subjects were randomized, 2 of them were not treated
|
3.1%
4/129
389 subjects were randomized, 2 of them were not treated
|
1.6%
2/128
389 subjects were randomized, 2 of them were not treated
|
|
Infections and infestations
Gastroenteritis
|
0.77%
1/130
389 subjects were randomized, 2 of them were not treated
|
1.6%
2/129
389 subjects were randomized, 2 of them were not treated
|
2.3%
3/128
389 subjects were randomized, 2 of them were not treated
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
7/130
389 subjects were randomized, 2 of them were not treated
|
7.0%
9/129
389 subjects were randomized, 2 of them were not treated
|
5.5%
7/128
389 subjects were randomized, 2 of them were not treated
|
|
Infections and infestations
Rhinitis
|
2.3%
3/130
389 subjects were randomized, 2 of them were not treated
|
2.3%
3/129
389 subjects were randomized, 2 of them were not treated
|
5.5%
7/128
389 subjects were randomized, 2 of them were not treated
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.8%
14/130
389 subjects were randomized, 2 of them were not treated
|
7.8%
10/129
389 subjects were randomized, 2 of them were not treated
|
11.7%
15/128
389 subjects were randomized, 2 of them were not treated
|
|
Nervous system disorders
Headache
|
17.7%
23/130
389 subjects were randomized, 2 of them were not treated
|
27.9%
36/129
389 subjects were randomized, 2 of them were not treated
|
29.7%
38/128
389 subjects were randomized, 2 of them were not treated
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
5/130
389 subjects were randomized, 2 of them were not treated
|
0.00%
0/129
389 subjects were randomized, 2 of them were not treated
|
0.00%
0/128
389 subjects were randomized, 2 of them were not treated
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
2.3%
3/130
389 subjects were randomized, 2 of them were not treated
|
1.6%
2/129
389 subjects were randomized, 2 of them were not treated
|
4.7%
6/128
389 subjects were randomized, 2 of them were not treated
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER