Japanese Encephalitis, Rabies
Conditions
Keywords
Rabies, JE, accelerated schedule
Brief summary
Establish non-inferiority of the immune response and evaluate the safety and tolerability of Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to either of 2 schedules for preexposure prophylaxis.
Interventions
BIOLOGICALRabies
Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).
BIOLOGICALJapanese Encephalitis
Subjects received two doses of Japanese Encephalitis vaccine.
OTHERPlacebo
Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females between 18 and 65 years of age (inclusive). 2. Subjects who have given written consent. 3. Individuals in good health as per investigator judgement.
Exclusion criteria
1. If female, pregnancy or unwillingness to practice acceptable contraception. 2. If female, pregnant or breast-feeding or any positive/indeterminate pregnancy test. 3. Contraindication or precaution against Rabies and Japanese Encephalitis vaccination. 4. Unable to comprehend and to follow all required study procedures for the whole period of the study. 5. Participating in any other clinical trial 30 days prior to first study visit. 6. History of previous rabies/rabies immunoglobulin and/or Japanese Encephalitis immunization. 7. Receiving or planning to receive anti-malarial medications (e.g. Mefloquine) 14 days prior to Day 1 vaccination through Day 43. 8. Received any other vaccines within 2 weeks prior to enrollment in this study or plan to receive any vaccine within 4 weeks from the study vaccines. 9. Ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks. 10. Individuals who are part of study personnel or close family members conducting this study. 11. Body temperature ≥38 degrees Celsius (≥ 100.4° F) within 3 days of intended study vaccination. 12. Plans to travel within the next year to areas where Rabies and/or Japanese Encephalitis vaccine may be considered or offered. This includes but is not limited to India, Asia, Pacific-Rim, African countries.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination | Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule) | Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule. As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv. |
| Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination | Day 28 after last active vaccination (day 36 - group that received accelerated schedule, day 57 - group that received conventional schedule) | Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule. As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination | Day 36 and day 57 (28 days after last active vaccination) | Immune response was measured as the percentages of subjects with RVNA concentration ≥0.5 IU/mL 28 days after last active vaccination, ie, day 36 for the group that received the accelerated schedule and day 57 for the group that received the conventional schedule. As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv. |
| Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination | Day 15 and day 36 (28 after last active vaccination) | Immune response was measured as the percentage of subjects with PRNT50 titer of ≥1:10 7 days after last active vaccination, ie, day 15 for the group that received the accelerated schedule and day 36 for the group that received the conventional schedule. As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv. |
| Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 1, 8, 15, 36, 57, 91, 181 and Day 366 | To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the percentage of subjects with RVNA concentrations ≥0.5 IU/mL on days 1, 8, 15, 36, 57, 91, 181, and 366. |
| Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 1, 8, 15, 36, 57, 91, 181, and 366 | To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the RVNA GMCs on days 1, 8, 15, 36, 57, 91, 181, and 366. |
| Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Days 1, 15, 22, 36, 57, 91, 181 and 366 | To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the percentage of subjects with PRNT50 titer ≥1:10 on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule). |
| RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination | Day 57 (28 days after last active vaccination) | Immune response was measured as the RVNA GMCs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule. Data were adjusted using ANOVA model, as per protocol specification. |
| Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Day 1 through day 7 after each vaccination (on day 1, 4, 8 and 29) | Safety was assessed as the number of subjects who reported solicited local adverse events (AEs) after each rabies vaccination given according to accelerated or conventional schedule as follows: from day 1 through day 7 (vaccination on day 1; all Rabies groups), day 4 through day 10 (vaccination on day 4; in R/JE - Acc group only), day 8 through day 14 (vaccination on day 8; all Rabies groups), or day 29 through day 35 (vaccination on day 29; R/JE - Conv and R - Conv groups). |
| Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Day 1 through day 7 after each vaccination (on day 1, 8 and 29) | Safety was assessed as the number of subjects who reported solicited local AEs after each JE vaccination given according to accelerated or conventional schedule as follow: from day 1 through day 7 (vaccination on day 1; all JE groups), day 8 through day 14 (vaccination on day 8; R/JE - Acc group only), or day 29 through day 35 (vaccination on day 29; R/JE - Con and JE - Conv groups). |
| Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Day 1 through day 7 after each injection (day 1, 4, 8 and 29) | Safety was assessed as the number of subjects who reported solicited local AEs after each placebo injection given according to accelerated and conventional schedule as follow: from day 1 through day 7 (injection on day 1; R - Conv and JE - Conv groups), day 4 through day 10 (injection on day 4; in R/JE - Conv, R - Conv and JE - Conv groups), day 8 through day 14 (injection on day 8; in R/JE - Conv, R - Conv and JE - Conv groups), and day 29 through day 35 (injection on day 29; R/JE - Acc, R - Con and JE - Conv groups). |
| Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29) | Safety was assessed as the number of subjects who reported solicited systemic AEs and other indicators of reactogenicity after each vaccination given according to accelerated and conventional schedule. |
| Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 | Day 1 through Day 57 | Safety was assessed as the number of subjects who reported unsolicited AEs after any vaccination given according to accelerated and conventional schedule. |
| Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule) | To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the PRNT50 GMTs on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule). |
| PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination | Day 57 (28 days after last active vaccination) | Immune response was measured as the PRNT50 GMTs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule. Data were adjusted using ANOVA model, as per protocol specifications. |
Countries
Austria, Germany, Switzerland
Participant flow
Recruitment details
Subjects were enrolled from five sites in Germany, one site in Austria, and one site in Switzerland.
Pre-assignment details
All subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| R/JE - Conv Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm. | 167 |
| R/JE - Acc Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm. | 217 |
| R - Conv Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm. | 221 |
| JE - Conv Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm. | 56 |
| Total | 661 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 1 |
| Overall Study | Death | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 | 4 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 |
| Overall Study | Subject moved to another country. | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | R/JE - Conv | R/JE - Acc | R - Conv | JE - Conv | Total |
|---|---|---|---|---|---|
| Age, Continuous | 37.3 year STANDARD_DEVIATION 13.4 | 36.8 year STANDARD_DEVIATION 12.7 | 35.7 year STANDARD_DEVIATION 12.6 | 38.8 year STANDARD_DEVIATION 13.3 | 36.7 year STANDARD_DEVIATION 12.9 |
| Sex: Female, Male Female | 76 Participants | 128 Participants | 125 Participants | 30 Participants | 359 Participants |
| Sex: Female, Male Male | 91 Participants | 89 Participants | 96 Participants | 26 Participants | 302 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 138 / 166 | 186 / 217 | 185 / 220 | 45 / 56 |
| serious Total, serious adverse events | 2 / 166 | 3 / 217 | 2 / 220 | 3 / 56 |
Outcome results
Primary
Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination
Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule. As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.
Time frame: Day 28 after last active vaccination (day 36 - group that received accelerated schedule, day 57 - group that received conventional schedule)
Population: Analysis was done on the PP dataset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| R/JE - Acc | Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination | 99 Percentages of subjects |
| R - Conv | Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination | 100 Percentages of subjects |
Comparison: Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) accelerated schedule as compared to conventional schedule at 28 day after last active vaccination97.5% CI: [-4.8, 7.9]
Primary
Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination
Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule. As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.
Time frame: Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule)
Population: Analysis was done on the per-protocol (PP) dataset, ie, the subjects who received the vaccine correctly, provided evaluable serum samples at the relevant time points, and had no major protocol violations as defined prior to unblinding.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| R/JE - Acc | Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination | 100 Percentages of subjects |
| R - Conv | Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination | 100 Percentages of subjects |
Comparison: To establish non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) accelerated schedule as compared to conventional schedule at 7 days after last active vaccination.97.5% CI: [-2.8, 2.8]
Secondary
Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10
To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the percentage of subjects with PRNT50 titer ≥1:10 on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).
Time frame: Days 1, 15, 22, 36, 57, 91, 181 and 366
Population: Analysis was done on the PP dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| R/JE - Acc | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 366 (N=154, 199, 48) | 86 Percentages of subjects |
| R/JE - Acc | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 36 (157, 206, 47) | 99 Percentages of subjects |
| R/JE - Acc | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 181 (N=155, 200, 49) | 94 Percentages of subjects |
| R/JE - Acc | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 1 | 1 Percentages of subjects |
| R/JE - Acc | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 57 (N=157, 204, 49) | 100 Percentages of subjects |
| R/JE - Acc | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 22 (N=0, 208, 0) | NA Percentages of subjects |
| R/JE - Acc | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 15 (N=0, 209, 0) | NA Percentages of subjects |
| R/JE - Acc | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 91 (N=0, 206, 0) | NA Percentages of subjects |
| R - Conv | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 1 | 6 Percentages of subjects |
| R - Conv | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 15 (N=0, 209, 0) | 99 Percentages of subjects |
| R - Conv | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 181 (N=155, 200, 49) | 98 Percentages of subjects |
| R - Conv | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 366 (N=154, 199, 48) | 94 Percentages of subjects |
| R - Conv | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 22 (N=0, 208, 0) | 100 Percentages of subjects |
| R - Conv | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 91 (N=0, 206, 0) | 98 Percentages of subjects |
| R - Conv | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 36 (157, 206, 47) | 99 Percentages of subjects |
| R - Conv | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 57 (N=157, 204, 49) | 98 Percentages of subjects |
| R - Conv | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 366 (N=154, 199, 48) | 88 Percentages of subjects |
| R - Conv | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 1 | 9 Percentages of subjects |
| R - Conv | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 22 (N=0, 208, 0) | NA Percentages of subjects |
| R - Conv | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 36 (157, 206, 47) | 100 Percentages of subjects |
| R - Conv | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 57 (N=157, 204, 49) | 100 Percentages of subjects |
| R - Conv | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 91 (N=0, 206, 0) | NA Percentages of subjects |
| R - Conv | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 181 (N=155, 200, 49) | 92 Percentages of subjects |
| R - Conv | Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 | Day 15 (N=0, 209, 0) | NA Percentages of subjects |
Secondary
Kinetics of JE Immune Response Measured as PRNT50 GMTs
To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the PRNT50 GMTs on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).
Time frame: Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule)
Population: Analysis was done on the PP dataset.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| R/JE - Acc | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 91 (N=0, 206, 0) | NA Titers |
| R/JE - Acc | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 36 (N=157, 206, 47) | 292 Titers |
| R/JE - Acc | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 366 (N=154, 199, 48) | 39 Titers |
| R/JE - Acc | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 57 (N= 157, 204, 49) | 299 Titers |
| R/JE - Acc | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 15 (N=0, 209, 0) | NA Titers |
| R/JE - Acc | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 1 | 5.13 Titers |
| R/JE - Acc | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 181 (N=155, 200, 49) | 63 Titers |
| R/JE - Acc | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 22 (0, 208, 0) | NA Titers |
| R - Conv | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 22 (0, 208, 0) | 1255 Titers |
| R - Conv | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 1 | 5.63 Titers |
| R - Conv | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 15 (N=0, 209, 0) | 715 Titers |
| R - Conv | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 36 (N=157, 206, 47) | 690 Titers |
| R - Conv | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 57 (N= 157, 204, 49) | 372 Titers |
| R - Conv | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 91 (N=0, 206, 0) | 228 Titers |
| R - Conv | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 181 (N=155, 200, 49) | 151 Titers |
| R - Conv | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 366 (N=154, 199, 48) | 117 Titers |
| R - Conv | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 1 | 5.73 Titers |
| R - Conv | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 91 (N=0, 206, 0) | NA Titers |
| R - Conv | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 15 (N=0, 209, 0) | NA Titers |
| R - Conv | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 366 (N=154, 199, 48) | 39 Titers |
| R - Conv | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 36 (N=157, 206, 47) | 376 Titers |
| R - Conv | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 181 (N=155, 200, 49) | 64 Titers |
| R - Conv | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 57 (N= 157, 204, 49) | 337 Titers |
| R - Conv | Kinetics of JE Immune Response Measured as PRNT50 GMTs | Day 22 (0, 208, 0) | NA Titers |
Secondary
Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL
To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the percentage of subjects with RVNA concentrations ≥0.5 IU/mL on days 1, 8, 15, 36, 57, 91, 181, and 366.
Time frame: Day 1, 8, 15, 36, 57, 91, 181 and Day 366
Population: Analysis was done on the PP dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| R/JE - Acc | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 1 | 1 Percentages of subjects |
| R/JE - Acc | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 8 (N=161, 210, 213) | 4 Percentages of subjects |
| R/JE - Acc | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 15 (N=161, 209, 210) | 99 Percentages of subjects |
| R/JE - Acc | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 36 (N=157, 206, 207) | 100 Percentages of subjects |
| R/JE - Acc | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 57 (157, 204, 204) | 100 Percentages of subjects |
| R/JE - Acc | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 91 (N=152, 206, 204) | 99 Percentages of subjects |
| R/JE - Acc | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 181 (N= 155, 200, 202) | 88 Percentages of subjects |
| R/JE - Acc | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 366 (154, 199, 204) | 76 Percentages of subjects |
| R - Conv | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 15 (N=161, 209, 210) | 100 Percentages of subjects |
| R - Conv | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 181 (N= 155, 200, 202) | 75 Percentages of subjects |
| R - Conv | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 36 (N=157, 206, 207) | 99 Percentages of subjects |
| R - Conv | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 57 (157, 204, 204) | 97 Percentages of subjects |
| R - Conv | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 91 (N=152, 206, 204) | 85 Percentages of subjects |
| R - Conv | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 1 | 1 Percentages of subjects |
| R - Conv | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 8 (N=161, 210, 213) | 16 Percentages of subjects |
| R - Conv | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 366 (154, 199, 204) | 68 Percentages of subjects |
| R - Conv | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 15 (N=161, 209, 210) | 99 Percentages of subjects |
| R - Conv | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 8 (N=161, 210, 213) | 4 Percentages of subjects |
| R - Conv | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 1 | 1 Percentages of subjects |
| R - Conv | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 36 (N=157, 206, 207) | 100 Percentages of subjects |
| R - Conv | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 181 (N= 155, 200, 202) | 89 Percentages of subjects |
| R - Conv | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 91 (N=152, 206, 204) | 98 Percentages of subjects |
| R - Conv | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 57 (157, 204, 204) | 100 Percentages of subjects |
| R - Conv | Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL | Day 366 (154, 199, 204) | 80 Percentages of subjects |
Secondary
Kinetics of Rabies Immune Response Measured as the RVNA GMCs
To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the RVNA GMCs on days 1, 8, 15, 36, 57, 91, 181, and 366.
Time frame: Day 1, 8, 15, 36, 57, 91, 181, and 366
Population: Analysis was done on the PP dataset.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| R/JE - Acc | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 1 | 0.052 IU/mL |
| R/JE - Acc | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 8 (N=161, 210, 213) | 0.071 IU/mL |
| R/JE - Acc | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 15 (N=161, 209, 210), | 21 IU/mL |
| R/JE - Acc | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 36 (N=157, 206, 207) | 14 IU/mL |
| R/JE - Acc | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 57 (N=157, 204, 204) | 10 IU/mL |
| R/JE - Acc | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 91 (N=152, 206, 204) | 4.79 IU/mL |
| R/JE - Acc | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 181 (N= 155, 200, 202) | 1.86 IU/mL |
| R/JE - Acc | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 366 (N=154, 199, 204) | 0.93 IU/mL |
| R - Conv | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 15 (N=161, 209, 210), | 26 IU/mL |
| R - Conv | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 181 (N= 155, 200, 202) | 1 IU/mL |
| R - Conv | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 36 (N=157, 206, 207) | 5.75 IU/mL |
| R - Conv | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 57 (N=157, 204, 204) | 3.01 IU/mL |
| R - Conv | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 91 (N=152, 206, 204) | 1.63 IU/mL |
| R - Conv | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 1 | 0.053 IU/mL |
| R - Conv | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 8 (N=161, 210, 213) | 0.13 IU/mL |
| R - Conv | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 366 (N=154, 199, 204) | 0.82 IU/mL |
| R - Conv | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 15 (N=161, 209, 210), | 24 IU/mL |
| R - Conv | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 8 (N=161, 210, 213) | 0.076 IU/mL |
| R - Conv | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 1 | 0.054 IU/mL |
| R - Conv | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 36 (N=157, 206, 207) | 13 IU/mL |
| R - Conv | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 181 (N= 155, 200, 202) | 2.04 IU/mL |
| R - Conv | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 91 (N=152, 206, 204) | 5.04 IU/mL |
| R - Conv | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 57 (N=157, 204, 204) | 9.66 IU/mL |
| R - Conv | Kinetics of Rabies Immune Response Measured as the RVNA GMCs | Day 366 (N=154, 199, 204) | 1.14 IU/mL |
Secondary
Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination
Safety was assessed as the number of subjects who reported solicited local adverse events (AEs) after each rabies vaccination given according to accelerated or conventional schedule as follows: from day 1 through day 7 (vaccination on day 1; all Rabies groups), day 4 through day 10 (vaccination on day 4; in R/JE - Acc group only), day 8 through day 14 (vaccination on day 8; all Rabies groups), or day 29 through day 35 (vaccination on day 29; R/JE - Conv and R - Conv groups).
Time frame: Day 1 through day 7 after each vaccination (on day 1, 4, 8 and 29)
Population: Analysis was done on the solicited safety set, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| R/JE - Acc | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Erythema (day 1 to 7) | 13 Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Induration (day 1 to 7) | 3 Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Pain (day 1 to 7) | 43 Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Erythema (day 4 to 10) | NA Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Induration (day 4 to 10) | NA Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Pain (day 4 to 10) | NA Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Erythema (day 8 to 14) | 8 Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Induration (day 8 to 14) | 10 Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Pain (day 8 to 14) | 57 Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Erythema (day 29 to 35) | 23 Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Induration (day 29 to 35) | 18 Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Pain (day 29 to 35) | 52 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Pain (day 29 to 35) | NA Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Erythema (day 1 to 7) | 31 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Erythema (day 8 to 14) | 31 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Pain (day 8 to 14) | 87 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Induration (day 1 to 7) | 16 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Pain (day 4 to 10) | 55 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Induration (day 29 to 35) | NA Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Pain (day 1 to 7) | 69 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Induration (day 8 to 14) | 15 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Induration (day 4 to 10) | 9 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Erythema (day 4 to 10) | 17 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Erythema (day 29 to 35) | NA Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Erythema (day 4 to 10) | NA Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Induration (day 4 to 10) | NA Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Erythema (day 29 to 35) | 45 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Pain (day 4 to 10) | NA Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Erythema (day 8 to 14) | 29 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Induration (day 8 to 14) | 17 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Induration (day 29 to 35) | 32 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Erythema (day 1 to 7) | 28 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Induration (day 1 to 7) | 11 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Pain (day 8 to 14) | 90 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Pain (day 1 to 7) | 72 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination | Pain (day 29 to 35) | 87 Number of subjects |
Secondary
Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination
Safety was assessed as the number of subjects who reported solicited local AEs after each JE vaccination given according to accelerated or conventional schedule as follow: from day 1 through day 7 (vaccination on day 1; all JE groups), day 8 through day 14 (vaccination on day 8; R/JE - Acc group only), or day 29 through day 35 (vaccination on day 29; R/JE - Con and JE - Conv groups).
Time frame: Day 1 through day 7 after each vaccination (on day 1, 8 and 29)
Population: Analysis was done on the solicited safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Erythema (day 29 to 35) | 12 Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Erythema (day 8 to 14) | NA Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Induration (day 1 to 7) | 13 Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Pain (day 8 to 14) | NA Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Induration (day 8 to 14) | NA Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Erythema (day 1 to 7) | 20 Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Induration (day 29 to 35) | 5 Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Pain (day 1 to 7) | 82 Number of subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Pain (day 29 to 35) | 46 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Erythema (day 29 to 35) | NA Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Erythema (day 1 to 7) | 30 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Induration (day 1 to 7) | 19 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Pain (day 1 to 7) | 102 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Erythema (day 8 to 14) | 18 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Induration (day 8 to 14) | 12 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Pain (day 8 to 14) | 60 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Induration (day 29 to 35) | NA Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Pain (day 29 to 35) | NA Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Pain (day 8 to 14) | NA Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Pain (day 1 to 7) | 26 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Erythema (day 29 to 35) | 5 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Induration (day 1 to 7) | 5 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Pain (day 29 to 35) | 12 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Induration (day 29 to 35) | 4 Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Induration (day 8 to 14) | NA Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Erythema (day 8 to 14) | NA Number of subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination | Erythema (day 1 to 7) | 6 Number of subjects |
Secondary
Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection
Safety was assessed as the number of subjects who reported solicited local AEs after each placebo injection given according to accelerated and conventional schedule as follow: from day 1 through day 7 (injection on day 1; R - Conv and JE - Conv groups), day 4 through day 10 (injection on day 4; in R/JE - Conv, R - Conv and JE - Conv groups), day 8 through day 14 (injection on day 8; in R/JE - Conv, R - Conv and JE - Conv groups), and day 29 through day 35 (injection on day 29; R/JE - Acc, R - Con and JE - Conv groups).
Time frame: Day 1 through day 7 after each injection (day 1, 4, 8 and 29)
Population: Analysis was done on the solicited safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 8 to 14 after 2nd Placebo dose) | NA Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 8 to 14) | 0 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 4 to 10) | 7 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 29 to 35 after 2nd Placebo dose) | NA Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 8 to 14 after 2nd Placebo dose) | NA Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 8 to 14) | 1 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 29 to 35 after 2nd Placebo dose) | NA Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 29 to 35) | NA Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 1 to 7) | NA Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 1 to 7) | NA Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 29 to 35 after 2nd Placebo dose) | NA Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 29 to 35) | NA Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 4 to 10) | 8 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 29 to 35) | NA Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 8 to 14 after 2nd Placebo dose) | NA Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 8 to 14) | 19 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 4 to 10) | 1 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 1 to 7) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 1 to 7) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 1 to 7) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 1 to 7) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 4 to 10) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 4 to 10) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 4 to 10) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 8 to 14) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 8 to 14 after 2nd Placebo dose) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 8 to 14) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 8 to 14 after 2nd Placebo dose) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 8 to 14) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 8 to 14 after 2nd Placebo dose) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 29 to 35) | 15 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 29 to 35 after 2nd Placebo dose) | 14 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 29 to 35) | 6 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 29 to 35 after 2nd Placebo dose) | 4 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 29 to 35) | 15 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 29 to 35 after 2nd Placebo dose) | 19 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 4 to 10) | 4 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 8 to 14 after 2nd Placebo dose) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 8 to 14) | 20 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 4 to 10) | 13 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 29 to 35 after 2nd Placebo dose) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 8 to 14 after 2nd Placebo dose) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 29 to 35) | 28 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 29 to 35) | 15 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 1 to 7) | 26 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 29 to 35 after 2nd Placebo dose) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 1 to 7) | 20 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 29 to 35) | 4 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 1 to 7) | 4 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 8 to 14) | 11 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 4 to 10) | 15 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 8 to 14 after 2nd Placebo dose) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 29 to 35 after 2nd Placebo dose) | NA Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 8 to 14) | 5 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 8 to 14) | 4 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 29 to 35 after 2nd Placebo dose) | NA Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 29 to 35 after 2nd Placebo dose) | NA Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 8 to 14 after 2nd Placebo dose) | 1 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 4 to 10) | 3 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 1 to 7) | 3 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 1 to 7) | 5 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 8 to 14) | 3 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 4 to 10) | 2 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 29 to 35 after 2nd Placebo dose) | NA Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 29 to 35) | 1 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 8 to 14 after 2nd Placebo dose) | 5 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 1 to 7) | 7 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 4 to 10) | 3 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Induration (day 8 to 14) | 1 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 29 to 35) | 3 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Erythema (day 8 to 14 after 2nd Placebo dose) | 3 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection | Pain (day 29 to 35) | 3 Number of Subjects |
Secondary
Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination
Safety was assessed as the number of subjects who reported solicited systemic AEs and other indicators of reactogenicity after each vaccination given according to accelerated and conventional schedule.
Time frame: Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29)
Population: Analysis was done on the solicited safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Fatigue (day 4 to 10) | 14 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Headache (day 1 to 7) | 35 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Myalgia (day 1 to 7) | 27 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Arthralgia (day 1 to 7) | 8 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Loss of Appetite (day1 to day 7) | 10 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Nausea (day1 to day 7) | 8 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Body temperature (≥38 °C, day 1 to day 7) | 1 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Analgesic/Antipyretic used (day 1 to day 7) | 11 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Fatigue (day 1 to 7) | 39 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Headache (day 4 to 10) | 17 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Myalgia (day 4 to 10) | 11 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Arthralgia (day 4 to 10) | 1 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Loss of Appetite (day4 to day 10) | 4 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Nausea (day4 to day 10) | 4 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Body temperature (≥38 °C, day 4 to day 10) | 1 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Analgesic/Antipyretic used (day 4 to 10) | 8 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Fatigue (day 8 to 14) | 24 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Headache (day 8 to 14) | 33 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Myalgia (day 8 to 14) | 22 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Arthralgia (day 8 to 14) | 6 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Loss of Appetite (day8 to day 14) | 10 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Nausea (day8 to day 14) | 5 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Body temperature (≥38 °C, day 8 to 14) | 2 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Analgesic/Antipyretic used (day 8 to 14) | 10 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Fatigue (day 29 to 35) | 21 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Headache (day 29 to 35) | 27 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Myalgia (day 29 to 35) | 23 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Arthralgia (day 29 to 35) | 5 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Body temperature (≥38 °C, day 29 to day 35) | 1 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Analgesic/Antipyretic used (day 29 to day 35) | 9 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Loss if appetite (day 29 to day 25) | 2 Number of Subjects |
| R/JE - Acc | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | nausea (day29 to day 25) | 7 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Analgesic/Antipyretic used (day 8 to 14) | 17 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Fatigue (day 8 to 14) | 47 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Nausea (day1 to day 7) | 7 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Body temperature (≥38 °C, day 8 to 14) | 1 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Body temperature (≥38 °C, day 29 to day 35) | 2 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Headache (day 8 to 14) | 43 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Headache (day 29 to 35) | 22 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Nausea (day8 to day 14) | 14 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Arthralgia (day 4 to 10) | 9 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Myalgia (day 8 to 14) | 41 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Headache (day 4 to 10) | 28 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Analgesic/Antipyretic used (day 29 to day 35) | 10 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Loss of Appetite (day8 to day 14) | 14 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Arthralgia (day 8 to 14) | 9 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Loss of Appetite (day1 to day 7) | 8 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | nausea (day29 to day 25) | 12 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Loss if appetite (day 29 to day 25) | 8 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Loss of Appetite (day4 to day 10) | 8 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Fatigue (day 4 to 10) | 30 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Arthralgia (day 1 to 7) | 13 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Arthralgia (day 29 to 35) | 6 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Nausea (day4 to day 10) | 5 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Body temperature (≥38 °C, day 1 to day 7) | 2 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Myalgia (day 1 to 7) | 55 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Analgesic/Antipyretic used (day 1 to day 7) | 11 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Body temperature (≥38 °C, day 4 to day 10) | 1 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Myalgia (day 4 to 10) | 19 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Headache (day 1 to 7) | 46 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Fatigue (day 29 to 35) | 29 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Analgesic/Antipyretic used (day 4 to 10) | 10 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Myalgia (day 29 to 35) | 15 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Fatigue (day 1 to 7) | 56 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Loss if appetite (day 29 to day 25) | 9 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Fatigue (day 4 to 10) | 33 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Headache (day 4 to 10) | 29 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Myalgia (day 29 to 35) | 28 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Myalgia (day 4 to 10) | 14 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Arthralgia (day 4 to 10) | 9 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Loss of Appetite (day4 to day 10) | 9 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Nausea (day4 to day 10) | 8 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Arthralgia (day 29 to 35) | 14 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Body temperature (≥38 °C, day 4 to day 10) | 2 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Analgesic/Antipyretic used (day 4 to 10) | 15 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Fatigue (day 8 to 14) | 47 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Headache (day 8 to 14) | 41 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Body temperature (≥38 °C, day 29 to day 35) | 1 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Myalgia (day 8 to 14) | 38 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Arthralgia (day 8 to 14) | 13 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Loss of Appetite (day8 to day 14) | 13 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Nausea (day8 to day 14) | 16 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Analgesic/Antipyretic used (day 29 to day 35) | 11 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Body temperature (≥38 °C, day 8 to 14) | 5 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Analgesic/Antipyretic used (day 8 to 14) | 20 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | nausea (day29 to day 25) | 9 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Fatigue (day 1 to 7) | 46 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Headache (day 1 to 7) | 38 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Fatigue (day 29 to 35) | 36 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Myalgia (day 1 to 7) | 31 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Arthralgia (day 1 to 7) | 7 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Loss of Appetite (day1 to day 7) | 12 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Nausea (day1 to day 7) | 13 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Headache (day 29 to 35) | 40 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Body temperature (≥38 °C, day 1 to day 7) | 2 Number of Subjects |
| R - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Analgesic/Antipyretic used (day 1 to day 7) | 8 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Myalgia (day 4 to 10) | 1 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Analgesic/Antipyretic used (day 4 to 10) | 2 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Headache (day 29 to 35) | 4 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Fatigue (day 1 to 7) | 16 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Arthralgia (day 29 to 35) | 1 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Body temperature (≥38 °C, day 4 to day 10) | 0 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Nausea (day1 to day 7) | 4 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Headache (day 1 to 7) | 14 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Fatigue (day 4 to 10) | 5 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Nausea (day4 to day 10) | 0 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Headache (day 4 to 10) | 3 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Myalgia (day 1 to 7) | 7 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Fatigue (day 29 to 35) | 3 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Loss of Appetite (day4 to day 10) | 2 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Analgesic/Antipyretic used (day 1 to day 7) | 3 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Arthralgia (day 1 to 7) | 1 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Arthralgia (day 8 to 14) | 1 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Body temperature (≥38 °C, day 29 to day 35) | 0 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Loss if appetite (day 29 to day 25) | 2 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Loss of Appetite (day8 to day 14) | 2 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Myalgia (day 8 to 14) | 1 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Headache (day 8 to 14) | 3 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Arthralgia (day 4 to 10) | 0 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Nausea (day8 to day 14) | 2 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Body temperature (≥38 °C, day 1 to day 7) | 0 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Fatigue (day 8 to 14) | 6 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Loss of Appetite (day1 to day 7) | 6 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Body temperature (≥38 °C, day 8 to 14) | 0 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Analgesic/Antipyretic used (day 29 to day 35) | 3 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | nausea (day29 to day 25) | 2 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Myalgia (day 29 to 35) | 2 Number of Subjects |
| JE - Conv | Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination | Analgesic/Antipyretic used (day 8 to 14) | 2 Number of Subjects |
Secondary
Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57
Safety was assessed as the number of subjects who reported unsolicited AEs after any vaccination given according to accelerated and conventional schedule.
Time frame: Day 1 through Day 57
Population: Analysis was done on the unsolicited safety set, ie, the subjects in the exposed population who provided postvaccination unsolicited safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| R/JE - Acc | Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 | Any AE | 69 Number of subjects |
| R/JE - Acc | Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 | AEs leading to premature withdrawal | 1 Number of subjects |
| R/JE - Acc | Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 | SAEs | 2 Number of subjects |
| R - Conv | Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 | Any AE | 108 Number of subjects |
| R - Conv | Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 | AEs leading to premature withdrawal | 0 Number of subjects |
| R - Conv | Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 | SAEs | 3 Number of subjects |
| R - Conv | Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 | SAEs | 2 Number of subjects |
| R - Conv | Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 | Any AE | 110 Number of subjects |
| R - Conv | Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 | AEs leading to premature withdrawal | 0 Number of subjects |
| JE - Conv | Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 | Any AE | 29 Number of subjects |
| JE - Conv | Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 | AEs leading to premature withdrawal | 1 Number of subjects |
| JE - Conv | Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 | SAEs | 3 Number of subjects |
Secondary
Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination
Immune response was measured as the percentage of subjects with PRNT50 titer of ≥1:10 7 days after last active vaccination, ie, day 15 for the group that received the accelerated schedule and day 36 for the group that received the conventional schedule. As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.
Time frame: Day 15 and day 36 (28 after last active vaccination)
Population: Analysis was done on the PP dataset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| R/JE - Acc | Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination | 99 Percentages of subjects |
| R - Conv | Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination | 100 Percentages of subjects |
Comparison: Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) as given according to an accelerated schedule as compared to JE vaccine (administered alone) as given according to a conventional schedule at 7day after last active vaccine administration.95% CI: [-4.1, 6.2]
Secondary
Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination
Immune response was measured as the percentages of subjects with RVNA concentration ≥0.5 IU/mL 28 days after last active vaccination, ie, day 36 for the group that received the accelerated schedule and day 57 for the group that received the conventional schedule. As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.
Time frame: Day 36 and day 57 (28 days after last active vaccination)
Population: Analysis was done on the PP set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| R/JE - Acc | Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination | 99 Percentages of subjects |
| R - Conv | Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination | 100 Percentages of subjects |
Comparison: Non-inferiority of the Rabies immune response (administered concomitantly with JE vaccine) as given according to an accelerated schedule as compared Rabies vaccine (administered alone) as given to a conventional schedule at day 28 after last active vaccination95% CI: [-3.8, 1.4]
Secondary
PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination
Immune response was measured as the PRNT50 GMTs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule. Data were adjusted using ANOVA model, as per protocol specifications.
Time frame: Day 57 (28 days after last active vaccination)
Population: Analysis was done on the PP dataset.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| R/JE - Acc | PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination | 291 Titers |
| R - Conv | PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination | 331 Titers |
Comparison: Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) as compared to JE vaccine (administered alone) as given according to conventional schedule at day 28 after last active vaccination.95% CI: [0.68, 1.13]
Secondary
RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination
Immune response was measured as the RVNA GMCs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule. Data were adjusted using ANOVA model, as per protocol specification.
Time frame: Day 57 (28 days after last active vaccination)
Population: Analysis was done on the PP dataset.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| R/JE - Acc | RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination | 11 IU/mL |
| R - Conv | RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination | 9.9 IU/mL |
Comparison: Non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) as compared to Rabies vaccines (administered alone) as given according to conventional schedule at 28day after last active vaccination95% CI: [0.86, 1.32]