Trial Outcomes & Findings for Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51 (NCT NCT00594958)
NCT ID: NCT00594958
Last Updated: 2024-03-21
Results Overview
Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
639 participants
Primary outcome timeframe
day 56
Results posted on
2024-03-21
Participant Flow
Participant milestones
| Measure |
IC51 Group A
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
IC51 Group B
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
IC51 Group C
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
|---|---|---|---|
|
Overall Study
STARTED
|
214
|
213
|
212
|
|
Overall Study
Randomized and at Least 1 Vaccination
|
212
|
213
|
211
|
|
Overall Study
COMPLETED
|
200
|
210
|
202
|
|
Overall Study
NOT COMPLETED
|
14
|
3
|
10
|
Reasons for withdrawal
| Measure |
IC51 Group A
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
IC51 Group B
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
IC51 Group C
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
4
|
1
|
2
|
|
Overall Study
Pregnancy
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
0
|
3
|
|
Overall Study
administrative
|
3
|
0
|
2
|
Baseline Characteristics
Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
Baseline characteristics by cohort
| Measure |
IC51 Group A
n=212 Participants
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
IC51 Group B
n=213 Participants
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
IC51 Group C
n=211 Participants
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
Total
n=636 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
31.3 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
30.7 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
31.3 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
350 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
286 Participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
212 participants
n=5 Participants
|
213 participants
n=7 Participants
|
211 participants
n=5 Participants
|
636 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: day 56Population: Per Protocol Population (observed values)
Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.
Outcome measures
| Measure |
IC51 Group A
n=197 Participants
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
IC51 Group B
n=202 Participants
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
IC51 Group C
n=200 Participants
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
|---|---|---|---|
|
GMT for Anti-JEV Neutralizing Antibody
|
160.71 GMT
Interval 140.54 to 183.76
|
272.24 GMT
Interval 237.22 to 312.43
|
127.56 GMT
Interval 109.51 to 148.57
|
SECONDARY outcome
Timeframe: study durationSafety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: day 56Outcome measures
Outcome data not reported
Adverse Events
IC51 Group A
Serious events: 3 serious events
Other events: 102 other events
Deaths: 0 deaths
IC51 Group B
Serious events: 2 serious events
Other events: 124 other events
Deaths: 0 deaths
IC51 Group C
Serious events: 5 serious events
Other events: 114 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IC51 Group A
n=212 participants at risk
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
IC51 Group B
n=213 participants at risk
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
IC51 Group C
n=211 participants at risk
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
|---|---|---|---|
|
Gastrointestinal disorders
Reflux Oesophagitis
|
0.47%
1/212 • up to Month 6
|
0.00%
0/213 • up to Month 6
|
0.00%
0/211 • up to Month 6
|
|
Gastrointestinal disorders
Acute Abdomen
|
0.00%
0/212 • up to Month 6
|
0.00%
0/213 • up to Month 6
|
0.47%
1/211 • up to Month 6
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/212 • up to Month 6
|
0.00%
0/213 • up to Month 6
|
0.47%
1/211 • up to Month 6
|
|
Infections and infestations
Erysipelas
|
0.00%
0/212 • up to Month 6
|
0.47%
1/213 • up to Month 6
|
0.00%
0/211 • up to Month 6
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/212 • up to Month 6
|
0.00%
0/213 • up to Month 6
|
0.47%
1/211 • up to Month 6
|
|
Infections and infestations
Peritonsillar Abscess
|
0.00%
0/212 • up to Month 6
|
0.47%
1/213 • up to Month 6
|
0.00%
0/211 • up to Month 6
|
|
Infections and infestations
Respiratory Tract Infection
|
0.47%
1/212 • up to Month 6
|
0.00%
0/213 • up to Month 6
|
0.00%
0/211 • up to Month 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/212 • up to Month 6
|
0.00%
0/213 • up to Month 6
|
0.47%
1/211 • up to Month 6
|
|
Nervous system disorders
Intracranial Aneurysm
|
0.47%
1/212 • up to Month 6
|
0.00%
0/213 • up to Month 6
|
0.00%
0/211 • up to Month 6
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/212 • up to Month 6
|
0.00%
0/213 • up to Month 6
|
0.47%
1/211 • up to Month 6
|
Other adverse events
| Measure |
IC51 Group A
n=212 participants at risk
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
IC51 Group B
n=213 participants at risk
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
IC51 Group C
n=211 participants at risk
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.7%
10/212 • up to Month 6
|
9.9%
21/213 • up to Month 6
|
7.1%
15/211 • up to Month 6
|
|
General disorders
Fatigue
|
9.9%
21/212 • up to Month 6
|
14.1%
30/213 • up to Month 6
|
16.1%
34/211 • up to Month 6
|
|
General disorders
Influenza Like Ilness
|
11.3%
24/212 • up to Month 6
|
16.4%
35/213 • up to Month 6
|
15.2%
32/211 • up to Month 6
|
|
Infections and infestations
Nasopharyngitis
|
13.2%
28/212 • up to Month 6
|
16.0%
34/213 • up to Month 6
|
14.2%
30/211 • up to Month 6
|
|
Infections and infestations
Rhinitis
|
5.7%
12/212 • up to Month 6
|
5.6%
12/213 • up to Month 6
|
4.7%
10/211 • up to Month 6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.6%
14/212 • up to Month 6
|
9.9%
21/213 • up to Month 6
|
8.5%
18/211 • up to Month 6
|
|
Nervous system disorders
Headache
|
19.8%
42/212 • up to Month 6
|
23.9%
51/213 • up to Month 6
|
24.6%
52/211 • up to Month 6
|
|
Gastrointestinal disorders
Diarrhoea
|
0.94%
2/212 • up to Month 6
|
2.3%
5/213 • up to Month 6
|
1.9%
4/211 • up to Month 6
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
2.4%
5/212 • up to Month 6
|
2.8%
6/213 • up to Month 6
|
1.4%
3/211 • up to Month 6
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
4/212 • up to Month 6
|
2.3%
5/213 • up to Month 6
|
0.47%
1/211 • up to Month 6
|
|
Infections and infestations
Acute Tonsillitis
|
2.4%
5/212 • up to Month 6
|
0.00%
0/213 • up to Month 6
|
0.00%
0/211 • up to Month 6
|
|
Infections and infestations
Gastroenteritis
|
0.47%
1/212 • up to Month 6
|
3.3%
7/213 • up to Month 6
|
0.95%
2/211 • up to Month 6
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.9%
4/212 • up to Month 6
|
2.3%
5/213 • up to Month 6
|
0.47%
1/211 • up to Month 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER