Trial Outcomes & Findings for Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population (NCT NCT01041573)
NCT ID: NCT01041573
Last Updated: 2021-07-27
Results Overview
Rate of subjects with these types of AEs, comparison vs respective control vaccine stratified by age group: All study participants aged \< 1 year: IC51 0.25mL vs. Prevnar; All study participants aged 1 year and above: IC51 0.25 mL or =.5 mL vs. Havrix.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1869 participants
Primary outcome timeframe
until Day 56
Results posted on
2021-07-27
Participant Flow
Participant milestones
| Measure |
IC51 0.5 mL
Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
|
IC51 0.25 mL
Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
|
Havrix 720
Havrix®720 0.5 ml i.m. at day 0 and month 7
|
Prevnar
Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day 56 and month 7-13
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
540
|
871
|
394
|
64
|
|
Overall Study
COMPLETED
|
535
|
858
|
387
|
62
|
|
Overall Study
NOT COMPLETED
|
5
|
13
|
7
|
2
|
Reasons for withdrawal
| Measure |
IC51 0.5 mL
Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
|
IC51 0.25 mL
Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
|
Havrix 720
Havrix®720 0.5 ml i.m. at day 0 and month 7
|
Prevnar
Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day 56 and month 7-13
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
2
|
1
|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
0
|
|
Overall Study
relocation
|
1
|
4
|
3
|
1
|
|
Overall Study
further blood extraction
|
0
|
1
|
0
|
0
|
|
Overall Study
positive to anti-HCV
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population
Baseline characteristics by cohort
| Measure |
IC51 0.25 mL
n=871 Participants
Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
|
IC51 0.5 mL
n=540 Participants
Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
|
Havrix 720
n=394 Participants
Havrix®720 0.5 ml i.m. at day 0 and month 7
|
Prevnar
n=64 Participants
Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day56 and month 7-13
|
Total
n=1869 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
2 months - < 1 year
|
131 participants
n=113 Participants
|
0 participants
n=163 Participants
|
0 participants
n=160 Participants
|
64 participants
n=483 Participants
|
195 participants
n=36 Participants
|
|
Age, Customized
1 year - < 3 years
|
640 participants
n=113 Participants
|
0 participants
n=163 Participants
|
213 participants
n=160 Participants
|
0 participants
n=483 Participants
|
853 participants
n=36 Participants
|
|
Age, Customized
3 years - < 12 years
|
100 participants
n=113 Participants
|
300 participants
n=163 Participants
|
101 participants
n=160 Participants
|
0 participants
n=483 Participants
|
501 participants
n=36 Participants
|
|
Age, Customized
12 years - < 18 years
|
0 participants
n=113 Participants
|
240 participants
n=163 Participants
|
80 participants
n=160 Participants
|
0 participants
n=483 Participants
|
320 participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
449 Participants
n=113 Participants
|
249 Participants
n=163 Participants
|
197 Participants
n=160 Participants
|
30 Participants
n=483 Participants
|
925 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
422 Participants
n=113 Participants
|
291 Participants
n=163 Participants
|
197 Participants
n=160 Participants
|
34 Participants
n=483 Participants
|
944 Participants
n=36 Participants
|
|
Region of Enrollment
Philippines
|
871 participants
n=113 Participants
|
540 participants
n=163 Participants
|
394 participants
n=160 Participants
|
64 participants
n=483 Participants
|
1869 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: until Day 56Population: As specified per protocol, safety parameters were compared between treatment groups (i.e. IC51 any dose level versus Havrix or Prevnar), stratified by age. Age was the determining factor of the respective safety comparators Prevnar (\<1yrs) and HAVRIX (1+ yrs). Different dose levels of IC51 were grouped for these analyses, to test the hypothesis that events do not occur in higher frequency after vaccination with IC51 compared to vaccination with Prevnar® or Havrix®720.
Rate of subjects with these types of AEs, comparison vs respective control vaccine stratified by age group: All study participants aged \< 1 year: IC51 0.25mL vs. Prevnar; All study participants aged 1 year and above: IC51 0.25 mL or =.5 mL vs. Havrix.
Outcome measures
| Measure |
IC51, Subjects Aged >= 1 Year
n=1280 Participants
IC51 Japanese Encephalitis: 6 mcg or 3 mcg im. at day 0 and day 28
|
Havrix 720
n=394 Participants
Havrix®720 0.5 ml im. at day 0 and month 7; active comparator for subjects aged \> 1 year
|
IC51, Subjects Aged >= 2 Months to <1 Year
n=131 Participants
Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
|
Prevnar
n=64 Participants
Active comparator in subjects aged ≥ 2 months to \< 1 year:
* Subjects aged ≥ 2 to \< 6 months: 4 intramuscular vaccinations, Days 0, 28, 56 and Month 7-13 (subjects aged ≥ 2 to \< 6 months were to receive the fourth Prevnar® vaccination when 12-15 months old, i.e., the vaccination was to be performed outside the study, depending on the subject´s age at day of first vaccination).
* Subjects aged ≥ 6 months to \< 1 year: 3 intramuscular vaccinations, Days 0, 56 and Month 7.
|
|---|---|---|---|---|
|
Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination
|
16.1 percentage of participants
Interval 14.1 to 18.2
|
14.2 percentage of participants
Interval 10.9 to 18.1
|
38.2 percentage of participants
Interval 29.8 to 47.1
|
42.2 percentage of participants
Interval 29.9 to 55.2
|
SECONDARY outcome
Timeframe: Day 0, 56 and at Month 7Population: Intent-to-treat Population: all subjects randomized into the immunogenicity subgroup, who received at least 1 vaccination. Subjects were analyzed according to the treatment group to which they were randomized rather than by the actual vaccine they received.
GMT for JEV neutralizing antibodies is presented per dose group rather than age group due to overlapping age groups. IC51 0.25 mL includes subjects aged 2 months to \< 12 years; IC51 0.5 mL includes subjects aged ≥ 3 years to \< 18 years.
Outcome measures
| Measure |
IC51, Subjects Aged >= 1 Year
n=255 Participants
IC51 Japanese Encephalitis: 6 mcg or 3 mcg im. at day 0 and day 28
|
Havrix 720
n=241 Participants
Havrix®720 0.5 ml im. at day 0 and month 7; active comparator for subjects aged \> 1 year
|
IC51, Subjects Aged >= 2 Months to <1 Year
Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
|
Prevnar
Active comparator in subjects aged ≥ 2 months to \< 1 year:
* Subjects aged ≥ 2 to \< 6 months: 4 intramuscular vaccinations, Days 0, 28, 56 and Month 7-13 (subjects aged ≥ 2 to \< 6 months were to receive the fourth Prevnar® vaccination when 12-15 months old, i.e., the vaccination was to be performed outside the study, depending on the subject´s age at day of first vaccination).
* Subjects aged ≥ 6 months to \< 1 year: 3 intramuscular vaccinations, Days 0, 56 and Month 7.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies
Day 0
|
5.79 Geometric Mean Titer
Standard Deviation 1.802
|
9.78 Geometric Mean Titer
Standard Deviation 2.944
|
—
|
—
|
|
Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies
Day 56
|
199.39 Geometric Mean Titer
Standard Deviation 3.387
|
190.77 Geometric Mean Titer
Standard Deviation 2.747
|
—
|
—
|
|
Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies
Month 7
|
37.99 Geometric Mean Titer
Standard Deviation 3.267
|
64.83 Geometric Mean Titer
Standard Deviation 3.242
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 0, 56 and at Month 7Population: "number analyzed" is dependent on number of serum samples available for testing
Seroconversion was defined as a PRNT50 titer of at least 1:10. SCRs are presented per dose group rather than age group due to overlapping age groups. IC51 0.25 mL includes subjects aged 2 months to \< 12 years; IC51 0.5 mL includes subjects aged ≥ 3 years to \< 18 years.
Outcome measures
| Measure |
IC51, Subjects Aged >= 1 Year
n=255 Participants
IC51 Japanese Encephalitis: 6 mcg or 3 mcg im. at day 0 and day 28
|
Havrix 720
n=241 Participants
Havrix®720 0.5 ml im. at day 0 and month 7; active comparator for subjects aged \> 1 year
|
IC51, Subjects Aged >= 2 Months to <1 Year
Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
|
Prevnar
Active comparator in subjects aged ≥ 2 months to \< 1 year:
* Subjects aged ≥ 2 to \< 6 months: 4 intramuscular vaccinations, Days 0, 28, 56 and Month 7-13 (subjects aged ≥ 2 to \< 6 months were to receive the fourth Prevnar® vaccination when 12-15 months old, i.e., the vaccination was to be performed outside the study, depending on the subject´s age at day of first vaccination).
* Subjects aged ≥ 6 months to \< 1 year: 3 intramuscular vaccinations, Days 0, 56 and Month 7.
|
|---|---|---|---|---|
|
Seroconversion Rate (SCR) at Days 0, 56 and at Month 7
Day 0
|
7.5 percentage of participants
Interval 4.8 to 11.4
|
33.6 percentage of participants
Interval 27.9 to 39.8
|
—
|
—
|
|
Seroconversion Rate (SCR) at Days 0, 56 and at Month 7
Day 56
|
98.0 percentage of participants
Interval 95.3 to 99.1
|
100.0 percentage of participants
Interval 98.4 to 100.0
|
—
|
—
|
|
Seroconversion Rate (SCR) at Days 0, 56 and at Month 7
Month 7
|
83.9 percentage of participants
Interval 78.8 to 87.9
|
94.5 percentage of participants
Interval 90.8 to 96.8
|
—
|
—
|
SECONDARY outcome
Timeframe: up to Month 7Population: As specified per protocol, safety parameters were compared between treatment groups (i.e. IC51 any dose level versus Havrix or Prevnar), stratified by age. Age was the determining factor of the respective safety comparators Prevnar (\<1yrs) and HAVRIX (1+ yrs). Different dose levels of IC51 were grouped for these analyses, to test the hypothesis that events do not occur in higher frequency after vaccination with IC51 compared to vaccination with Prevnar® or Havrix®720.
Rate of subjects with SAEs and medically attended AEs; For this analysis IC51 vaccine recipients are displayed by age group rather than by dose group. This allows comparison of the safety profile of IC51 with the active control for the respective age group: Prevnar for study participants aged \>= 2 months to \<1 year and Havrix 720 for study participants aged \>= 1 year.
Outcome measures
| Measure |
IC51, Subjects Aged >= 1 Year
n=1280 Participants
IC51 Japanese Encephalitis: 6 mcg or 3 mcg im. at day 0 and day 28
|
Havrix 720
n=394 Participants
Havrix®720 0.5 ml im. at day 0 and month 7; active comparator for subjects aged \> 1 year
|
IC51, Subjects Aged >= 2 Months to <1 Year
n=131 Participants
Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
|
Prevnar
n=64 Participants
Active comparator in subjects aged ≥ 2 months to \< 1 year:
* Subjects aged ≥ 2 to \< 6 months: 4 intramuscular vaccinations, Days 0, 28, 56 and Month 7-13 (subjects aged ≥ 2 to \< 6 months were to receive the fourth Prevnar® vaccination when 12-15 months old, i.e., the vaccination was to be performed outside the study, depending on the subject´s age at day of first vaccination).
* Subjects aged ≥ 6 months to \< 1 year: 3 intramuscular vaccinations, Days 0, 56 and Month 7.
|
|---|---|---|---|---|
|
Rate of Subjects With SAEs and Medically Attended AEs
Rate of subjects with SAE
|
0.5 percentage of participants
Interval 0.2 to 1.0
|
1.0 percentage of participants
Interval 0.3 to 2.6
|
0 percentage of participants
Interval 0.0 to 2.8
|
1.6 percentage of participants
Interval 0.0 to 8.4
|
|
Rate of Subjects With SAEs and Medically Attended AEs
Rate of subjects with medically attended AE
|
16.1 percentage of participants
Interval 14.1 to 18.2
|
14.2 percentage of participants
Interval 10.9 to 18.1
|
38.2 percentage of participants
Interval 29.8 to 47.1
|
42.2 percentage of participants
Interval 29.9 to 55.2
|
SECONDARY outcome
Timeframe: 7 days post vaccinationPopulation: As specified per protocol, safety parameters were compared between treatment groups (i.e. IC51 any dose level versus Havrix or Prevnar), stratified by age. Age was the determining factor of the respective safety comparators Prevnar (\<1yrs) and HAVRIX (1+ yrs). Different dose levels of IC51 were grouped for these analyses, to test the hypothesis that events do not occur in higher frequency after vaccination with IC51 compared to vaccination with Prevnar® or Havrix®720.
Rate of subjects with solicited local and systemic AEs. Solicited AEs of local and systemic tolerability, i.e., reactions at the injection site or systemic reactions typical for vaccinations, were to be evaluated for 7 consecutive days after each vaccination (except after the HAVRIX®750 and Prevnar® injections at Month 7 \[Visit 4\]) and recorded in the subject diary. For this analysis IC51 vaccine recipients are displayed by age group rather than by dose group. This allows comparison of the safety profile of IC51 with the active control for the respective age group: Prevnar for study participants aged \>= 2 months to \<1 year and Havrix 720 for study participants aged \>= 1 year.
Outcome measures
| Measure |
IC51, Subjects Aged >= 1 Year
n=1280 Participants
IC51 Japanese Encephalitis: 6 mcg or 3 mcg im. at day 0 and day 28
|
Havrix 720
n=394 Participants
Havrix®720 0.5 ml im. at day 0 and month 7; active comparator for subjects aged \> 1 year
|
IC51, Subjects Aged >= 2 Months to <1 Year
n=131 Participants
Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
|
Prevnar
n=64 Participants
Active comparator in subjects aged ≥ 2 months to \< 1 year:
* Subjects aged ≥ 2 to \< 6 months: 4 intramuscular vaccinations, Days 0, 28, 56 and Month 7-13 (subjects aged ≥ 2 to \< 6 months were to receive the fourth Prevnar® vaccination when 12-15 months old, i.e., the vaccination was to be performed outside the study, depending on the subject´s age at day of first vaccination).
* Subjects aged ≥ 6 months to \< 1 year: 3 intramuscular vaccinations, Days 0, 56 and Month 7.
|
|---|---|---|---|---|
|
Rate of Subjects With Solicited Local and Systemic AEs
|
40.8 percentage of participants
Interval 38.1 to 43.5
|
29.4 percentage of participants
Interval 25.0 to 34.2
|
58 percentage of participants
Interval 49.1 to 66.6
|
59.4 percentage of participants
Interval 46.4 to 71.5
|
SECONDARY outcome
Timeframe: Day 56 and up to Month 7Population: As specified per protocol, safety parameters were compared between treatment groups (i.e. IC51 any dose level versus Havrix or Prevnar), stratified by age. Age was the determining factor of the respective safety comparators Prevnar (\<1yrs) and HAVRIX (1+ yrs). Different dose levels of IC51 were grouped for these analyses, to test the hypothesis that events do not occur in higher frequency after vaccination with IC51 compared to vaccination with Prevnar® or Havrix®720.
Rate of subjects with unsolicited AEs up to Day 56 and up to Month 7; For this analysis IC51 vaccine recipients are displayed by age group rather than by dose group. This allows comparison of the safety profile of IC51 with the active control for the respective age group: Prevnar for study participants aged \>= 2 months to \<1 year and Havrix 720 for study participants aged \>= 1 year.
Outcome measures
| Measure |
IC51, Subjects Aged >= 1 Year
n=1280 Participants
IC51 Japanese Encephalitis: 6 mcg or 3 mcg im. at day 0 and day 28
|
Havrix 720
n=394 Participants
Havrix®720 0.5 ml im. at day 0 and month 7; active comparator for subjects aged \> 1 year
|
IC51, Subjects Aged >= 2 Months to <1 Year
n=131 Participants
Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
|
Prevnar
n=64 Participants
Active comparator in subjects aged ≥ 2 months to \< 1 year:
* Subjects aged ≥ 2 to \< 6 months: 4 intramuscular vaccinations, Days 0, 28, 56 and Month 7-13 (subjects aged ≥ 2 to \< 6 months were to receive the fourth Prevnar® vaccination when 12-15 months old, i.e., the vaccination was to be performed outside the study, depending on the subject´s age at day of first vaccination).
* Subjects aged ≥ 6 months to \< 1 year: 3 intramuscular vaccinations, Days 0, 56 and Month 7.
|
|---|---|---|---|---|
|
Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7
Day 56
|
46.5 percentage of participants
Interval 43.7 to 49.3
|
46.4 percentage of participants
Interval 41.4 to 51.5
|
72.5 percentage of participants
Interval 64.0 to 80.0
|
65.6 percentage of participants
Interval 52.7 to 77.1
|
|
Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7
Month 7
|
58.5 percentage of participants
Interval 55.8 to 61.2
|
57.6 percentage of participants
Interval 52.6 to 62.5
|
77.1 percentage of participants
Interval 68.9 to 84.0
|
81.3 percentage of participants
Interval 69.5 to 89.9
|
SECONDARY outcome
Timeframe: Day 56 and Month 7Population: Urinalysis Evaluations were not mandatory unless the subject was at least 12 years old at V0.
Rate of subjects with abnormal laboratory parameters clinically significant results are shown below
Outcome measures
| Measure |
IC51, Subjects Aged >= 1 Year
n=871 Participants
IC51 Japanese Encephalitis: 6 mcg or 3 mcg im. at day 0 and day 28
|
Havrix 720
n=540 Participants
Havrix®720 0.5 ml im. at day 0 and month 7; active comparator for subjects aged \> 1 year
|
IC51, Subjects Aged >= 2 Months to <1 Year
n=394 Participants
Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
|
Prevnar
n=64 Participants
Active comparator in subjects aged ≥ 2 months to \< 1 year:
* Subjects aged ≥ 2 to \< 6 months: 4 intramuscular vaccinations, Days 0, 28, 56 and Month 7-13 (subjects aged ≥ 2 to \< 6 months were to receive the fourth Prevnar® vaccination when 12-15 months old, i.e., the vaccination was to be performed outside the study, depending on the subject´s age at day of first vaccination).
* Subjects aged ≥ 6 months to \< 1 year: 3 intramuscular vaccinations, Days 0, 56 and Month 7.
|
|---|---|---|---|---|
|
Rate of Subjects With Abnormal Laboratory Parameters
Calcium Month 7
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
AST Day 56
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
AST Month 7
|
5 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
ALT Day 56
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Red Blood Cells Day 56
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Red Blood Cells Month 7
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Hemoglobin Day 56
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Hemoglobin Month 7
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Hematocrit Day 56
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Hematocrit Month 7
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
White Blood Cells Day 56
|
8 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
White Blood Cells Month 7
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Platelets Day 56
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Platelets Month 7
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Potassium Day 56
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Potassium Month 7
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Calcium Day 56
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
ALT Month 7
|
4 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Alkaline Phosphatase Day 56
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Alkaline Phosphatase Month 7
|
7 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Bilirubin Day 56
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Bilirubin Month 7
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Creatinine Day 56
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Creatinine Month 7
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Sodium Day 56
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Rate of Subjects With Abnormal Laboratory Parameters
Sodium Month 7
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
IC51 0.25 mL
Serious events: 16 serious events
Other events: 691 other events
Deaths: 0 deaths
IC51 0.5 mL
Serious events: 7 serious events
Other events: 300 other events
Deaths: 0 deaths
Havrix 720
Serious events: 10 serious events
Other events: 252 other events
Deaths: 0 deaths
Prevnar
Serious events: 1 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IC51 0.25 mL
n=871 participants at risk
Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
|
IC51 0.5 mL
n=540 participants at risk
Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
|
Havrix 720
n=394 participants at risk
Havrix®720 0.5 ml i.m. at day 0 and month 7
|
Prevnar
n=64 participants at risk
Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day 56 and month 7-13
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.34%
3/871 • Number of events 3 • 7 months after first vaccination
|
0.19%
1/540 • Number of events 1 • 7 months after first vaccination
|
0.51%
2/394 • Number of events 2 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Nervous system disorders
Febrile Convulsion
|
0.57%
5/871 • Number of events 5 • 7 months after first vaccination
|
0.00%
0/540 • 7 months after first vaccination
|
0.76%
3/394 • Number of events 3 • 7 months after first vaccination
|
1.6%
1/64 • Number of events 1 • 7 months after first vaccination
|
|
Infections and infestations
Bronchopneumonia
|
0.23%
2/871 • Number of events 2 • 7 months after first vaccination
|
0.00%
0/540 • 7 months after first vaccination
|
0.25%
1/394 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Infections and infestations
Dengue Fever
|
0.11%
1/871 • Number of events 1 • 7 months after first vaccination
|
0.19%
1/540 • Number of events 1 • 7 months after first vaccination
|
0.25%
1/394 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Infections and infestations
Gastroenteritis
|
0.23%
2/871 • Number of events 2 • 7 months after first vaccination
|
0.00%
0/540 • 7 months after first vaccination
|
0.25%
1/394 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Infections and infestations
Cellulitis
|
0.11%
1/871 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/540 • 7 months after first vaccination
|
0.00%
0/394 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Infections and infestations
Hepatitis A
|
0.11%
1/871 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/540 • 7 months after first vaccination
|
0.00%
0/394 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Infections and infestations
Meningitis Bacterial
|
0.00%
0/871 • 7 months after first vaccination
|
0.19%
1/540 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/394 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/871 • 7 months after first vaccination
|
0.19%
1/540 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/394 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Infections and infestations
Typhoid Fever
|
0.00%
0/871 • 7 months after first vaccination
|
0.19%
1/540 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/394 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/871 • 7 months after first vaccination
|
0.19%
1/540 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/394 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Infections and infestations
Urinary Tract Infection
|
0.11%
1/871 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/540 • 7 months after first vaccination
|
0.00%
0/394 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Vascular disorders
Haematoma
|
0.11%
1/871 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/540 • 7 months after first vaccination
|
0.00%
0/394 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Vascular disorders
Kawasaki´s Disease
|
0.00%
0/871 • 7 months after first vaccination
|
0.19%
1/540 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/394 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.00%
0/871 • 7 months after first vaccination
|
0.19%
1/540 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/394 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Congenital, familial and genetic disorders
Familial Periodic Paralysis
|
0.00%
0/871 • 7 months after first vaccination
|
0.00%
0/540 • 7 months after first vaccination
|
0.25%
1/394 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Eye disorders
Strabismus
|
0.00%
0/871 • 7 months after first vaccination
|
0.19%
1/540 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/394 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/871 • 7 months after first vaccination
|
0.19%
1/540 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/394 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/871 • 7 months after first vaccination
|
0.00%
0/540 • 7 months after first vaccination
|
0.25%
1/394 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.00%
0/871 • 7 months after first vaccination
|
0.19%
1/540 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/394 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/871 • 7 months after first vaccination
|
0.00%
0/540 • 7 months after first vaccination
|
0.25%
1/394 • Number of events 1 • 7 months after first vaccination
|
0.00%
0/64 • 7 months after first vaccination
|
Other adverse events
| Measure |
IC51 0.25 mL
n=871 participants at risk
Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
|
IC51 0.5 mL
n=540 participants at risk
Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
|
Havrix 720
n=394 participants at risk
Havrix®720 0.5 ml i.m. at day 0 and month 7
|
Prevnar
n=64 participants at risk
Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day 56 and month 7-13
|
|---|---|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
37.4%
326/871 • Number of events 414 • 7 months after first vaccination
|
12.4%
67/540 • Number of events 72 • 7 months after first vaccination
|
24.6%
97/394 • Number of events 115 • 7 months after first vaccination
|
51.6%
33/64 • Number of events 50 • 7 months after first vaccination
|
|
Infections and infestations
Gastroenteritis
|
6.7%
58/871 • Number of events 61 • 7 months after first vaccination
|
0.56%
3/540 • Number of events 3 • 7 months after first vaccination
|
3.6%
14/394 • Number of events 14 • 7 months after first vaccination
|
14.1%
9/64 • Number of events 12 • 7 months after first vaccination
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
77/871 • Number of events 89 • 7 months after first vaccination
|
2.6%
14/540 • Number of events 16 • 7 months after first vaccination
|
6.9%
27/394 • Number of events 27 • 7 months after first vaccination
|
7.8%
5/64 • Number of events 6 • 7 months after first vaccination
|
|
General disorders
Pyrexia
|
14.0%
122/871 • Number of events 127 • 7 months after first vaccination
|
6.5%
35/540 • Number of events 36 • 7 months after first vaccination
|
9.1%
36/394 • Number of events 40 • 7 months after first vaccination
|
12.5%
8/64 • Number of events 10 • 7 months after first vaccination
|
|
Skin and subcutaneous tissue disorders
Heat Rash
|
1.0%
9/871 • Number of events 10 • 7 months after first vaccination
|
0.74%
4/540 • Number of events 4 • 7 months after first vaccination
|
1.0%
4/394 • Number of events 4 • 7 months after first vaccination
|
6.2%
4/64 • Number of events 5 • 7 months after first vaccination
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
30/871 • Number of events 32 • 7 months after first vaccination
|
0.56%
3/540 • Number of events 3 • 7 months after first vaccination
|
2.5%
10/394 • Number of events 10 • 7 months after first vaccination
|
7.8%
5/64 • Number of events 5 • 7 months after first vaccination
|
|
Infections and infestations
Rhinitis
|
5.2%
45/871 • Number of events 48 • 7 months after first vaccination
|
1.5%
8/540 • Number of events 8 • 7 months after first vaccination
|
4.3%
17/394 • Number of events 19 • 7 months after first vaccination
|
4.7%
3/64 • Number of events 5 • 7 months after first vaccination
|
|
General disorders
Injection Site Pain
|
5.9%
15/256 • Number of events 17 • 7 months after first vaccination
|
12.2%
65/532 • Number of events 74 • 7 months after first vaccination
|
8.8%
20/228 • Number of events 20 • 7 months after first vaccination
|
—
0/0 • 7 months after first vaccination
|
|
General disorders
Tenderness
|
4.4%
38/871 • Number of events 40 • 7 months after first vaccination
|
8.9%
48/540 • Number of events 55 • 7 months after first vaccination
|
6.9%
27/394 • Number of events 27 • 7 months after first vaccination
|
12.7%
8/63 • Number of events 10 • 7 months after first vaccination
|
|
General disorders
Hardening
|
1.1%
10/871 • Number of events 10 • 7 months after first vaccination
|
1.5%
8/540 • Number of events 8 • 7 months after first vaccination
|
0.51%
2/394 • Number of events 2 • 7 months after first vaccination
|
7.9%
5/63 • Number of events 6 • 7 months after first vaccination
|
|
General disorders
Swelling
|
3.9%
34/871 • Number of events 35 • 7 months after first vaccination
|
2.6%
14/540 • Number of events 15 • 7 months after first vaccination
|
3.0%
12/394 • Number of events 15 • 7 months after first vaccination
|
7.9%
5/63 • Number of events 6 • 7 months after first vaccination
|
|
General disorders
Redness
|
9.3%
81/871 • Number of events 93 • 7 months after first vaccination
|
4.1%
22/540 • Number of events 22 • 7 months after first vaccination
|
6.3%
25/394 • Number of events 25 • 7 months after first vaccination
|
36.5%
23/63 • Number of events 30 • 7 months after first vaccination
|
|
General disorders
Flu-like symptoms
|
7.8%
21/268 • Number of events 23 • 7 months after first vaccination
|
3.0%
16/532 • Number of events 17 • 7 months after first vaccination
|
6.8%
16/235 • Number of events 16 • 7 months after first vaccination
|
—
0/0 • 7 months after first vaccination
|
|
Nervous system disorders
Headache
|
4.3%
10/233 • Number of events 10 • 7 months after first vaccination
|
5.8%
31/531 • Number of events 37 • 7 months after first vaccination
|
4.6%
10/219 • Number of events 10 • 7 months after first vaccination
|
—
0/0 • 7 months after first vaccination
|
|
General disorders
Fever
|
28.0%
244/871 • Number of events 316 • 7 months after first vaccination
|
11.3%
61/540 • Number of events 76 • 7 months after first vaccination
|
12.4%
49/394 • Number of events 53 • 7 months after first vaccination
|
38.1%
24/63 • Number of events 31 • 7 months after first vaccination
|
|
General disorders
Irritability
|
10.0%
87/871 • Number of events 111 • 7 months after first vaccination
|
1.1%
6/540 • Number of events 9 • 7 months after first vaccination
|
4.1%
16/394 • Number of events 17 • 7 months after first vaccination
|
14.3%
9/63 • Number of events 16 • 7 months after first vaccination
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
58/871 • Number of events 69 • 7 months after first vaccination
|
1.9%
10/540 • Number of events 11 • 7 months after first vaccination
|
3.3%
13/394 • Number of events 14 • 7 months after first vaccination
|
7.9%
5/63 • Number of events 5 • 7 months after first vaccination
|
|
Gastrointestinal disorders
Diarrhea
|
10.8%
94/871 • Number of events 113 • 7 months after first vaccination
|
1.1%
6/540 • Number of events 6 • 7 months after first vaccination
|
3.3%
13/394 • Number of events 13 • 7 months after first vaccination
|
9.5%
6/63 • Number of events 7 • 7 months after first vaccination
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
49/871 • Number of events 57 • 7 months after first vaccination
|
0.93%
5/540 • Number of events 5 • 7 months after first vaccination
|
1.5%
6/394 • Number of events 6 • 7 months after first vaccination
|
14.3%
9/63 • Number of events 9 • 7 months after first vaccination
|
|
Metabolism and nutrition disorders
Loss of appetite
|
7.5%
65/871 • Number of events 78 • 7 months after first vaccination
|
2.0%
11/540 • Number of events 14 • 7 months after first vaccination
|
3.3%
13/394 • Number of events 16 • 7 months after first vaccination
|
9.5%
6/63 • Number of events 12 • 7 months after first vaccination
|
|
General disorders
Excessive Fatigue
|
3.2%
28/871 • Number of events 32 • 7 months after first vaccination
|
2.2%
12/540 • Number of events 14 • 7 months after first vaccination
|
1.3%
5/394 • Number of events 5 • 7 months after first vaccination
|
7.9%
5/63 • Number of events 7 • 7 months after first vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER