Trial Outcomes & Findings for Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With JE-CV (NCT NCT01190228)
NCT ID: NCT01190228
Last Updated: 2022-03-28
Results Overview
The presence of JE virus neutralizing antibodies was measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Day 7 and Day 28) was defined as neutralizing antibody titer ≥ 10 (1/dilution).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
454 participants
Primary outcome timeframe
Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination
Results posted on
2022-03-28
Participant Flow
Study participants were enrolled from 25 August 2010 to 12 October 2015 at 3 clinic sites in the Philippines.
A total of 454 participants who met all inclusion criteria and no exclusion criteria were enrolled in Group 1 or randomized to Group 2 or Group 3 on Day 0. All except 4 participants in Group 1 were vaccinated as planned (345 participants in Group 1, 46 participants in Group 2, and 59 participants in Group 3).
Participant milestones
| Measure |
JE-CV Vaccine Booster
Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
|
JE-CV Vaccine First Dose
JE vaccine naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
|
Varicella Vaccine Group
JE vaccine naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
|
|---|---|---|---|
|
Overall Study
STARTED
|
349
|
46
|
59
|
|
Overall Study
COMPLETED
|
344
|
46
|
59
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
0
|
Reasons for withdrawal
| Measure |
JE-CV Vaccine Booster
Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
|
JE-CV Vaccine First Dose
JE vaccine naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
|
Varicella Vaccine Group
JE vaccine naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With JE-CV
Baseline characteristics by cohort
| Measure |
JE-CV Vaccine Booster
n=345 Participants
Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
|
JE-CV Vaccine First Dose
n=46 Participants
JE vaccine naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
|
Varicella Vaccine Group
n=59 Participants
JE vaccine naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
|
Total
n=450 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
345 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
450 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
39.6 Months
STANDARD_DEVIATION 1.71 • n=5 Participants
|
39.3 Months
STANDARD_DEVIATION 1.99 • n=7 Participants
|
39.3 Months
STANDARD_DEVIATION 2.09 • n=5 Participants
|
39.5 Months
STANDARD_DEVIATION 1.79 • n=4 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
226 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
173 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Region of Enrollment
Philippines
|
345 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
450 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccinationPopulation: Seroprotection against JE-CV vaccine was assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.
The presence of JE virus neutralizing antibodies was measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Day 7 and Day 28) was defined as neutralizing antibody titer ≥ 10 (1/dilution).
Outcome measures
| Measure |
JE-CV Booster
n=340 Participants
Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
|
JE-CV First Dose
n=39 Participants
JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
|
Varicella Vaccine Group
JE naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
|
|---|---|---|---|
|
Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV
Day 0 (pre-vaccination)
|
80.3 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV
Day 7 post-vaccination
|
96.2 Percentage of participants
|
15.4 Percentage of participants
|
—
|
|
Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV
Day 28 post-vaccination
|
100.0 Percentage of participants
|
89.7 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccinationPopulation: Seroconversion was assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or participants with pre vaccination titer ≥10 (1/dilution) and a ≥4-fold increase from pre- to post-vaccination.
Outcome measures
| Measure |
JE-CV Booster
n=340 Participants
Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
|
JE-CV First Dose
n=39 Participants
JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
|
Varicella Vaccine Group
JE naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
|
|---|---|---|---|
|
Percentage of Participants With JE Seroconversion Following a Dose of Live Attenuated JE-CV Vaccine
Day 7 post-vaccination
|
66.8 Percentage of participants
|
15.4 Percentage of participants
|
—
|
|
Percentage of Participants With JE Seroconversion Following a Dose of Live Attenuated JE-CV Vaccine
Day 28 post-vaccination
|
95.3 Percentage of participants
|
89.7 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccinationPopulation: Geometric mean titers of JE virus antibodies were assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
Outcome measures
| Measure |
JE-CV Booster
n=340 Participants
Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
|
JE-CV First Dose
n=39 Participants
JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
|
Varicella Vaccine Group
JE naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
|
|---|---|---|---|
|
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV
Day 0 (pre-vaccination)
|
39.4 Titers (1/dilution)
Interval 33.7 to 46.0
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
—
|
|
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV
Day 7 post-vaccination
|
231 Titers (1/dilution)
Interval 191.0 to 279.0
|
6.41 Titers (1/dilution)
Interval 5.11 to 8.05
|
—
|
|
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV
Day 28 post-vaccination
|
2242 Titers (1/dilution)
Interval 1913.0 to 2628.0
|
178 Titers (1/dilution)
Interval 99.7 to 318.0
|
—
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccinationPopulation: Geometric mean titer ratios of JE virus antibodies were assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
Outcome measures
| Measure |
JE-CV Booster
n=340 Participants
Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
|
JE-CV First Dose
n=39 Participants
JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
|
Varicella Vaccine Group
JE naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
|
|---|---|---|---|
|
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV
Day 7 post-vaccination
|
5.87 Titer ratios (1/dilution)
Interval 5.06 to 6.8
|
1.28 Titer ratios (1/dilution)
Interval 1.02 to 1.61
|
—
|
|
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV
Day 28 post-vaccination
|
57.0 Titer ratios (1/dilution)
Interval 47.8 to 67.9
|
35.6 Titer ratios (1/dilution)
Interval 19.9 to 63.6
|
—
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination)Population: Serological flavivirus status at baseline was assessed in the Full Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Flavivirus positive was defined as titers against JE virus ≥10 (1/dilution) or titers against at least 1 dengue serotype ≥10 (1/dilution). Flavivirus negative was defined as titers against JE virus \<10 (1/dilution) and titers against the 4 dengue serotypes \<10 (1/dilution).
Outcome measures
| Measure |
JE-CV Booster
n=345 Participants
Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
|
JE-CV First Dose
n=46 Participants
JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
|
Varicella Vaccine Group
JE naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
|
|---|---|---|---|
|
Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV
Any JE-CV and/or dengue virus; Flavivirus positive
|
289 Number of participants
|
14 Number of participants
|
—
|
|
Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV
Any JE-CV and/or dengue virus; Flavivirus negative
|
56 Number of participants
|
32 Number of participants
|
—
|
|
Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV
JE-CV virus strain
|
277 Number of participants
|
7 Number of participants
|
—
|
|
Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV
Any dengue serotype
|
121 Number of participants
|
11 Number of participants
|
—
|
|
Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV
Dengue serotype 1
|
116 Number of participants
|
11 Number of participants
|
—
|
|
Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV
Dengue serotype 2
|
102 Number of participants
|
11 Number of participants
|
—
|
|
Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV
Dengue serotype 3
|
96 Number of participants
|
9 Number of participants
|
—
|
|
Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV
Dengue serotype 4
|
108 Number of participants
|
9 Number of participants
|
—
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Days 7 and 28, and Year 1, 2, 3, 4, and 5 post-vaccinationPopulation: Seroprotection was assessed in the Full Analysis Set. Data for JE-CV Vaccine First Dose and Varicella Vaccine Groups were not analyzed for this outcome measure as pre-specified in the study protocol.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Days 7 and 28 and Years 1, 2, 3, 4, and 5) was defined as neutralizing antibody titer ≥ 10 (1/dilution).
Outcome measures
| Measure |
JE-CV Booster
n=345 Participants
Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
|
JE-CV First Dose
JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
|
Varicella Vaccine Group
JE naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
|
|---|---|---|---|
|
Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Day 0 (pre-vaccination)
|
80.3 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Day 7 post-vaccination
|
96.2 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Day 28 post-vaccination
|
100.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Year 1 post-vaccination
|
99.4 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Year 2 post-vaccination
|
98.8 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Year 3 post-vaccination
|
99.1 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Year 4 post-vaccination
|
98.2 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Year 5 post-vaccination
|
98.2 Percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Days 7 and 28 and Year 1, 2, 3, 4, and 5 post-vaccinationPopulation: Geometric mean titers of JE virus antibodies were assessed in the Full Analysis Set. Data for JE-CV Vaccine First Dose and Varicella Vaccine Groups were not analyzed for this outcome measure as pre-specified in the study protocol.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
Outcome measures
| Measure |
JE-CV Booster
n=345 Participants
Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
|
JE-CV First Dose
JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
|
Varicella Vaccine Group
JE naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
|
|---|---|---|---|
|
Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Day 0 (pre-vaccination)
|
39.3 Titers (1/dilution)
Interval 33.7 to 45.8
|
—
|
—
|
|
Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Day 7 post-vaccination
|
233 Titers (1/dilution)
Interval 193.0 to 281.0
|
—
|
—
|
|
Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Day 28 post-vaccination
|
2259 Titers (1/dilution)
Interval 1930.0 to 2645.0
|
—
|
—
|
|
Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Year 1 post-vaccination
|
596 Titers (1/dilution)
Interval 502.0 to 708.0
|
—
|
—
|
|
Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Year 2 post-vaccination
|
368 Titers (1/dilution)
Interval 313.0 to 432.0
|
—
|
—
|
|
Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Year 3 post-vaccination
|
301 Titers (1/dilution)
Interval 257.0 to 352.0
|
—
|
—
|
|
Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Year 4 post-vaccination
|
249 Titers (1/dilution)
Interval 215.0 to 289.0
|
—
|
—
|
|
Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Year 5 post-vaccination
|
161 Titers (1/dilution)
Interval 141.0 to 184.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Year 1, 2, 3, 4, and 5 post-vaccinationPopulation: Geometric mean titer ratios of JE virus antibodies were assessed in the Full Analysis Set. Data for JE-CV Vaccine First Dose and Varicella Vaccine Groups were not analyzed for this outcome measure as pre-specified in the study protocol.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
Outcome measures
| Measure |
JE-CV Booster
n=345 Participants
Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
|
JE-CV First Dose
JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
|
Varicella Vaccine Group
JE naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
|
|---|---|---|---|
|
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Year 2/Year 1
|
0.615 Titer ratios (1/dilution)
Interval 0.539 to 0.701
|
—
|
—
|
|
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Year 3/Year 2
|
0.821 Titer ratios (1/dilution)
Interval 0.734 to 0.919
|
—
|
—
|
|
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Year 4/Year 3
|
0.827 Titer ratios (1/dilution)
Interval 0.746 to 0.916
|
—
|
—
|
|
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Year 5/Year 4
|
0.646 Titer ratios (1/dilution)
Interval 0.584 to 0.715
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 up to Day 14 post-vaccinationPopulation: Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection-site reactions: Pain, Incapacitating, unable to perform usual activities. Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, 39.0°C; Headache, Malaise, and Myalgia, Significant; prevents daily activities.
Outcome measures
| Measure |
JE-CV Booster
n=345 Participants
Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
|
JE-CV First Dose
n=46 Participants
JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
|
Varicella Vaccine Group
n=59 Participants
JE naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
|
|---|---|---|---|
|
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
Injection-site Pain
|
73 Participants
|
13 Participants
|
12 Participants
|
|
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
Grade 3 Injection-site Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
Injection-site Erythema
|
29 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
Grade 3 Injection-site Erythema
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
Injection-site Swelling
|
19 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
Grade 3 Injection-site Swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
Fever
|
49 Participants
|
1 Participants
|
9 Participants
|
|
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
Grade 3 Fever
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
Headache
|
41 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
Grade 3 Headache
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
Malaise
|
49 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
Grade 3 Malaise
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
Myalgia
|
19 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
Grade 3 Myalgia
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
JE-CV Vaccine Booster
Serious events: 3 serious events
Other events: 73 other events
Deaths: 0 deaths
JE-CV Vaccine First Dose
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Varicella Vaccine Group
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
JE-CV Vaccine Booster
n=345 participants at risk
Participants previously received a single dose of JE-CV Vaccine in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
|
JE-CV Vaccine First Dose
n=46 participants at risk
JE vaccine naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
|
Varicella Vaccine Group
n=59 participants at risk
JE vaccine naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
|
|---|---|---|---|
|
Infections and infestations
Dengue fever
|
0.58%
2/345 • Number of events 2 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
0.00%
0/46 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
0.00%
0/59 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
|
Nervous system disorders
Febrile convulsion
|
0.29%
1/345 • Number of events 1 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
0.00%
0/46 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
0.00%
0/59 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
Other adverse events
| Measure |
JE-CV Vaccine Booster
n=345 participants at risk
Participants previously received a single dose of JE-CV Vaccine in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
|
JE-CV Vaccine First Dose
n=46 participants at risk
JE vaccine naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
|
Varicella Vaccine Group
n=59 participants at risk
JE vaccine naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
|
|---|---|---|---|
|
Infections and infestations
Rhinitis
|
3.5%
12/345 • Number of events 12 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
2.2%
1/46 • Number of events 1 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
5.1%
3/59 • Number of events 3 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.7%
37/345 • Number of events 41 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
6.5%
3/46 • Number of events 4 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
10.2%
6/59 • Number of events 6 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
|
General disorders
Injection site Pain
|
21.2%
73/345 • Number of events 73 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
28.3%
13/46 • Number of events 13 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
20.3%
12/59 • Number of events 12 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
|
General disorders
Injection site Erythema
|
8.4%
29/345 • Number of events 29 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
2.2%
1/46 • Number of events 1 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
6.8%
4/59 • Number of events 4 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
|
General disorders
Injection site Swelling
|
5.5%
19/345 • Number of events 19 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
0.00%
0/46 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
1.7%
1/59 • Number of events 1 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
|
General disorders
Fever
|
14.2%
49/345 • Number of events 49 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
2.2%
1/46 • Number of events 1 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
15.3%
9/59 • Number of events 9 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
|
Nervous system disorders
Headache
|
11.9%
41/345 • Number of events 41 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
10.9%
5/46 • Number of events 5 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
13.6%
8/59 • Number of events 8 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
|
General disorders
Malaise
|
14.2%
49/345 • Number of events 49 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
13.0%
6/46 • Number of events 6 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
10.2%
6/59 • Number of events 6 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.5%
19/345 • Number of events 19 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
4.3%
2/46 • Number of events 2 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
3.4%
2/59 • Number of events 2 • Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER