Trial Outcomes & Findings for Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries (NCT NCT01047839)
NCT ID: NCT01047839
Last Updated: 2020-06-30
Results Overview
Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
until Day 56
Results posted on
2020-06-30
Participant Flow
Participant milestones
| Measure |
>=2 Months to <3 Years
IC51 0.25 ml, 2 intramuscular vaccinations at Day 0 and Day 28
|
>=3 to <12 Years
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
>=12 to <18 Years
IC51, 0.5 ml, 2 intramuscular vaccinations at Day 0 and 28
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
29
|
59
|
|
Overall Study
COMPLETED
|
10
|
29
|
53
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
Baseline characteristics by cohort
| Measure |
>=2 Months to <3 Years
n=12 Participants
IC51 0.25 ml, 2 i.m.vaccinations at Day 0 and Day 28
|
>=3 to <12 Years
n=29 Participants
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
>=12 to <18 Years
n=59 Participants
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
1.81 years
STANDARD_DEVIATION 0.811 • n=5 Participants
|
6.98 years
STANDARD_DEVIATION 2.417 • n=7 Participants
|
15.90 years
STANDARD_DEVIATION 1.176 • n=5 Participants
|
11.62 years
STANDARD_DEVIATION 5.605 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: until Day 56Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.
Outcome measures
| Measure |
>=2 Months to <3 Years
n=12 Participants
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
|
>=3 to <12 Years
n=29 Participants
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
>=12 to <18 Years
n=59 Participants
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
|---|---|---|---|
|
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination
|
33.3 percentage of participants
Interval 9.9 to 65.1
|
20.7 percentage of participants
Interval 8.0 to 39.7
|
3.4 percentage of participants
Interval 0.4 to 11.7
|
SECONDARY outcome
Timeframe: up to Month 7Outcome measures
| Measure |
>=2 Months to <3 Years
n=12 Participants
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
|
>=3 to <12 Years
n=88 Participants
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
>=12 to <18 Years
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
|---|---|---|---|
|
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination
SAEs
|
0 percentage of participants
Interval 0.0 to 26.5
|
3.4 percentage of participants
Interval 0.7 to 9.6
|
—
|
|
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination
medically attended AEs
|
33.3 percentage of participants
Interval 9.9 to 65.1
|
18.2 percentage of participants
Interval 10.8 to 27.8
|
—
|
SECONDARY outcome
Timeframe: 7 daysOutcome measures
| Measure |
>=2 Months to <3 Years
n=12 Participants
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
|
>=3 to <12 Years
n=88 Participants
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
>=12 to <18 Years
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
|---|---|---|---|
|
Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination
any Local after 1st Vaccination
|
28.6 percentage of participants
Interval 2.1 to 48.4
|
48.9 percentage of participants
Interval 38.1 to 59.8
|
—
|
|
Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination
any Systemic after 1st Vaccination
|
33.3 percentage of participants
Interval 2.1 to 48.4
|
46.0 percentage of participants
Interval 34.8 to 56.4
|
—
|
|
Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination
any Local after 2nd Vaccination
|
22.2 percentage of participants
Interval 2.3 to 51.8
|
29.4 percentage of participants
Interval 20.0 to 40.3
|
—
|
|
Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination
any Systemic after 2nd Vaccination
|
28.6 percentage of participants
Interval 2.3 to 51.8
|
22.6 percentage of participants
Interval 14.0 to 32.7
|
—
|
SECONDARY outcome
Timeframe: up to Day 56 and upt to Month 7Outcome measures
| Measure |
>=2 Months to <3 Years
n=12 Participants
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
|
>=3 to <12 Years
n=88 Participants
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
>=12 to <18 Years
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
|---|---|---|---|
|
Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination
any unsolicited AE up to Day 56
|
83.3 percentage of participants
Interval 51.6 to 97.9
|
29.5 percentage of participants
Interval 20.3 to 40.2
|
—
|
|
Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination
any unsolicited AE up to Month 7
|
91.7 percentage of participants
Interval 61.5 to 99.8
|
43.2 percentage of participants
Interval 32.7 to 54.2
|
—
|
SECONDARY outcome
Timeframe: up to Month 7Population: not from all subjects samples were collected, Overall number of participants analyzed were number of participants at Day 0
Laboratory parameters were assessed at the Day 28, Day 56 and Month 7 visit. Endpoint reflects abnormal laboratory parameters assessed as clinically significant by the investigator.
Outcome measures
| Measure |
>=2 Months to <3 Years
n=12 Participants
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
|
>=3 to <12 Years
n=88 Participants
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
>=12 to <18 Years
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
|---|---|---|---|
|
Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination
White Blood cells on Day 28
|
1 Participants
|
0 Participants
|
—
|
|
Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination
Platelets on Day 28
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: at Day 56 and Month 7Population: number analyzed = number of subjects achieving seroconversion Overall number of participants analyzed were number of participants at Day 0
Outcome measures
| Measure |
>=2 Months to <3 Years
n=12 Participants
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
|
>=3 to <12 Years
n=88 Participants
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
>=12 to <18 Years
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
|---|---|---|---|
|
SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)
SCR Day 56
|
100.0 percentage of participants
Interval 56.6 to 100.0
|
100.0 percentage of participants
Interval 93.7 to 100.0
|
—
|
|
SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)
SCR Month 7
|
100.0 percentage of participants
Interval 34.2 to 100.0
|
90.6 percentage of participants
Interval 75.8 to 96.8
|
—
|
SECONDARY outcome
Timeframe: at Day 56 and Month 7Outcome measures
| Measure |
>=2 Months to <3 Years
n=5 Participants
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
|
>=3 to <12 Years
n=59 Participants
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
>=12 to <18 Years
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
|---|---|---|---|
|
GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7
GMT Day 56
|
216.18 Titer
Interval 105.97 to 441.0
|
340.74 Titer
Interval 269.83 to 430.28
|
—
|
|
GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7
GMT Month 7
|
47.96 Titer
Interval 0.0 to 3214485.72
|
57.12 Titer
Interval 38.41 to 84.94
|
—
|
SECONDARY outcome
Timeframe: at Day 56 and Month 7Population: number analyzed = number of subjects achieving seroconversion Overall number of participants analyzed were number of participants at Day 0
Outcome measures
| Measure |
>=2 Months to <3 Years
n=12 Participants
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
|
>=3 to <12 Years
n=29 Participants
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
>=12 to <18 Years
n=59 Participants
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
|---|---|---|---|
|
SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups
SCR Day 56
|
100 percentage of participants
Interval 56.6 to 100.0
|
100.0 percentage of participants
Interval 79.6 to 100.0
|
100.0 percentage of participants
Interval 91.6 to 100.0
|
|
SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups
SCR Month 7
|
100.0 percentage of participants
Interval 34.2 to 100.0
|
66.7 percentage of participants
Interval 20.8 to 93.9
|
93.1 percentage of participants
Interval 78.0 to 98.1
|
SECONDARY outcome
Timeframe: at Day 56 and Month 7Outcome measures
| Measure |
>=2 Months to <3 Years
n=5 Participants
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
|
>=3 to <12 Years
n=15 Participants
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
>=12 to <18 Years
n=42 Participants
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
|---|---|---|---|
|
GMTs at Day 56 and Month 7 Stratified According to Age Groups
GMT Day 56
|
216.18 Titer
Interval 105.97 to 441.0
|
508.03 Titer
Interval 267.76 to 963.9
|
295.44 Titer
Interval 235.96 to 369.9
|
|
GMTs at Day 56 and Month 7 Stratified According to Age Groups
GMT Month 7
|
47.96 Titer
Interval 0.0 to 3214485.72
|
31.96 Titer
Interval 0.48 to 2120.78
|
60.65 Titer
Interval 40.72 to 90.36
|
Adverse Events
>=2 Months to <3 Years
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
>=3 to <12 Years
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
>=12 to <18 Years
Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
>=2 Months to <3 Years
n=12 participants at risk
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
|
>=3 to <12 Years
n=29 participants at risk
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
>=12 to <18 Years
n=59 participants at risk
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/12
|
0.00%
0/29
|
1.7%
1/59 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12
|
0.00%
0/29
|
1.7%
1/59 • Number of events 1
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/12
|
0.00%
0/29
|
1.7%
1/59 • Number of events 1
|
Other adverse events
| Measure |
>=2 Months to <3 Years
n=12 participants at risk
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
|
>=3 to <12 Years
n=29 participants at risk
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
>=12 to <18 Years
n=59 participants at risk
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
33.3%
4/12 • Number of events 4
|
13.8%
4/29 • Number of events 4
|
0.00%
0/59
|
|
Infections and infestations
Bronchitis
|
8.3%
1/12 • Number of events 1
|
0.00%
0/29
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.3%
1/12 • Number of events 2
|
6.9%
2/29 • Number of events 3
|
0.00%
0/59
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
8.3%
1/12 • Number of events 1
|
0.00%
0/29
|
5.1%
3/59 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • Number of events 3
|
3.4%
1/29 • Number of events 1
|
3.4%
2/59 • Number of events 2
|
|
Gastrointestinal disorders
Haematochezia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/29
|
0.00%
0/59
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12
|
6.9%
2/29 • Number of events 2
|
5.1%
3/59 • Number of events 7
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1
|
6.9%
2/29 • Number of events 2
|
5.1%
3/59 • Number of events 3
|
|
General disorders
Pyrexia
|
25.0%
3/12 • Number of events 5
|
6.9%
2/29 • Number of events 3
|
1.7%
1/59 • Number of events 1
|
|
General disorders
Influenza like Illness
|
8.3%
1/12 • Number of events 1
|
0.00%
0/29
|
1.7%
1/59 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
2/12 • Number of events 2
|
10.3%
3/29 • Number of events 3
|
1.7%
1/59 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Erythema
|
8.3%
1/12 • Number of events 1
|
6.9%
2/29 • Number of events 2
|
1.7%
1/59 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
16.7%
2/12 • Number of events 2
|
10.3%
3/29 • Number of events 4
|
0.00%
0/59
|
|
Ear and labyrinth disorders
Ear Canal Erythema
|
8.3%
1/12 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
0.00%
0/59
|
|
Injury, poisoning and procedural complications
Excoriation
|
8.3%
1/12 • Number of events 1
|
0.00%
0/29
|
0.00%
0/59
|
|
Investigations
White Blood Cell Count Decreased
|
8.3%
1/12 • Number of events 1
|
0.00%
0/29
|
0.00%
0/59
|
|
Psychiatric disorders
Initial Insomnia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/29
|
0.00%
0/59
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 1
|
3.4%
1/29 • Number of events 2
|
0.00%
0/59
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
8.3%
1/12 • Number of events 1
|
0.00%
0/29
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/12
|
6.9%
2/29 • Number of events 3
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/12
|
6.9%
2/29 • Number of events 2
|
0.00%
0/59
|
|
Nervous system disorders
Headache
|
0.00%
0/12
|
10.3%
3/29 • Number of events 5
|
6.8%
4/59 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Orapharyngeal Pain
|
0.00%
0/12
|
3.4%
1/29 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
|
General disorders
Injection Site Pain
|
0.00%
0/12
|
10.3%
3/29 • Number of events 3
|
32.2%
19/59 • Number of events 25
|
|
General disorders
Injection Site Itching
|
0.00%
0/12
|
3.4%
1/29 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
|
General disorders
Tenderness
|
8.3%
1/12 • Number of events 1
|
44.8%
13/29 • Number of events 19
|
52.5%
31/59 • Number of events 42
|
|
General disorders
Hardening
|
8.3%
1/12 • Number of events 2
|
0.00%
0/29
|
6.8%
4/59 • Number of events 4
|
|
General disorders
Redness
|
25.0%
3/12 • Number of events 3
|
6.9%
2/29 • Number of events 2
|
3.4%
2/59 • Number of events 2
|
|
General disorders
Irritability
|
0.00%
0/12
|
17.2%
5/29 • Number of events 7
|
1.7%
1/59 • Number of events 1
|
|
General disorders
Excessive Fatigue
|
0.00%
0/12
|
10.3%
3/29 • Number of events 3
|
11.9%
7/59 • Number of events 7
|
|
General disorders
Muscle Pain
|
0.00%
0/12
|
13.8%
4/29 • Number of events 5
|
39.0%
23/59 • Number of events 29
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12
|
10.3%
3/29 • Number of events 4
|
1.7%
1/59 • Number of events 1
|
|
General disorders
Loss of appetite
|
8.3%
1/12 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
0.00%
0/59
|
|
General disorders
Fever
|
0.00%
0/12
|
3.4%
1/29 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
Additional Information
Senior Scientist Clinical Research
Valneva Austria GmbH
Phone: +43 1 206 20
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER