Trial Outcomes & Findings for Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country (NCT NCT01296360)
NCT ID: NCT01296360
Last Updated: 2014-12-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
1 month post booster
Results posted on
2014-12-19
Participant Flow
Participant milestones
| Measure |
Booster Group
IC51 booster vaccination \~12 months after primary immunization in study IC51-323
|
Non-Booster Group
No treatment in study IC51-325
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
Visit 2 (Month 12)
|
148
|
149
|
|
Overall Study
Visit 2a (Month 13)
|
148
|
0
|
|
Overall Study
COMPLETED
|
144
|
142
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country
Baseline characteristics by cohort
| Measure |
Booster Group
n=150 Participants
IC51 booster vaccination \~12 months after primary immunization in study IC51-323
|
Non-Booster Group
n=150 Participants
No treatment in study IC51-325
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.23 years
STANDARD_DEVIATION 5.084 • n=5 Participants
|
5.36 years
STANDARD_DEVIATION 5.135 • n=7 Participants
|
5.30 years
STANDARD_DEVIATION 5.101 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month post boosterPopulation: Intent-to-treat Population: primary analysis population for the immunogenicity analyses; defined as all subjects randomized
Outcome measures
| Measure |
>14 Months to <2 Years
n=81 Participants
booster vaccination: IXIARO 0.25 ml i.m. (milliliter, intramuscular)
|
>3 Years - <18 Years
n=67 Participants
booster vaccination: IXIARO 0.5 ml i.m (milliliter, intramuscular)
|
|---|---|---|
|
SCRs (Seroconversion Rate) as Defined by Percentage of Subjects With Plaque Reduction Neutralization Test Titers of>1:10 at 1 Month After the Booster Dose
|
100 percentage of subjects
Interval 95.5 to 100.0
|
100 percentage of subjects
Interval 94.6 to 100.0
|
SECONDARY outcome
Timeframe: 1 monthOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 monthOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 monthOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 monthOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 daysOutcome measures
Outcome data not reported
Adverse Events
Booster Group
Serious events: 7 serious events
Other events: 99 other events
Deaths: 0 deaths
Non-Booster Group
Serious events: 3 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Booster Group
n=150 participants at risk
IC51 booster vaccination \~12 months after primary immunization in study IC51-323
|
Non-Booster Group
n=150 participants at risk
No treatment in study IC51-325
|
|---|---|---|
|
Infections and infestations
Abscess
|
0.67%
1/150
|
0.00%
0/150
|
|
Infections and infestations
Amoebic dysentery
|
0.67%
1/150
|
0.00%
0/150
|
|
Infections and infestations
Bronchopneumonia
|
0.67%
1/150
|
0.00%
0/150
|
|
Infections and infestations
Dengue fever
|
0.67%
1/150
|
0.00%
0/150
|
|
Infections and infestations
Gastroenteritis
|
0.67%
1/150
|
0.00%
0/150
|
|
Infections and infestations
Urinary tract infection
|
0.67%
1/150
|
0.00%
0/150
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/150
|
0.67%
1/150
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/150
|
0.67%
1/150
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/150
|
0.67%
1/150
|
|
Nervous system disorders
Paralysis
|
0.00%
0/150
|
0.67%
1/150
|
|
Surgical and medical procedures
Finger amputation
|
0.67%
1/150
|
0.00%
0/150
|
Other adverse events
| Measure |
Booster Group
n=150 participants at risk
IC51 booster vaccination \~12 months after primary immunization in study IC51-323
|
Non-Booster Group
n=150 participants at risk
No treatment in study IC51-325
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
24.7%
37/150
|
22.7%
34/150
|
|
Infections and infestations
Rhinitis
|
11.3%
17/150
|
10.7%
16/150
|
|
Infections and infestations
Nasopharyngitis
|
10.7%
16/150
|
10.0%
15/150
|
|
Infections and infestations
Varicella
|
6.0%
9/150
|
9.3%
14/150
|
|
Infections and infestations
Gastroenteritis
|
4.7%
7/150
|
5.3%
8/150
|
|
Infections and infestations
Bronchitis
|
4.0%
6/150
|
5.3%
8/150
|
|
Infections and infestations
Impetigo
|
6.7%
10/150
|
2.7%
4/150
|
|
Infections and infestations
Viral infection
|
6.0%
9/150
|
3.3%
5/150
|
|
General disorders
Pyrexia
|
6.7%
10/150
|
5.3%
8/150
|
|
General disorders
Fever
|
8.0%
12/150
|
0.00%
0/150
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER