Trial Outcomes & Findings for Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects (NCT NCT01662440)

NCT ID: NCT01662440

Last Updated: 2014-12-08

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 661 participants
• Primary outcome timeframe: Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule)
• Results posted on: 2014-12-08

Participant Flow

Subjects were enrolled from five sites in Germany, one site in Austria, and one site in Switzerland.

All subjects were included in the trial.

Participant milestones

Measure	R/JE - Conv Subjects received Rabies and Japanese Encephalitis (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.	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.	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.	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.
Overall Study STARTED	167	217	221	56
Overall Study COMPLETED	158	211	215	52
Overall Study NOT COMPLETED	9	6	6	4

Reasons for withdrawal

Measure	R/JE - Conv Subjects received Rabies and Japanese Encephalitis (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.	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.	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.	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.
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 Subject moved to another country.	0	1	0	0
Overall Study Protocol Violation	1	0	0	0
Overall Study Withdrawal by Subject	5	2	2	2

Baseline Characteristics

Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects

Baseline characteristics by cohort

Measure	R/JE - Conv n=167 Participants 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.	R/JE - Acc n=217 Participants 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.	R - Conv n=221 Participants 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.	JE - Conv n=56 Participants 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.	Total n=661 Participants Total of all reporting groups
Age, Continuous	37.3 year STANDARD_DEVIATION 13.4 • n=93 Participants	36.8 year STANDARD_DEVIATION 12.7 • n=4 Participants	35.7 year STANDARD_DEVIATION 12.6 • n=27 Participants	38.8 year STANDARD_DEVIATION 13.3 • n=483 Participants	36.7 year STANDARD_DEVIATION 12.9 • n=36 Participants
Sex: Female, Male Female	76 Participants n=93 Participants	128 Participants n=4 Participants	125 Participants n=27 Participants	30 Participants n=483 Participants	359 Participants n=36 Participants
Sex: Female, Male Male	91 Participants n=93 Participants	89 Participants n=4 Participants	96 Participants n=27 Participants	26 Participants n=483 Participants	302 Participants n=36 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	R/JE - Acc n=209 Participants 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.	R - Conv n=207 Participants 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.	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.	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.
Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination	100 Percentages of subjects Interval 97.0 to 100.0	100 Percentages of subjects Interval 97.0 to 100.0	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	R/JE - Acc n=209 Participants 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.	R - Conv n=49 Participants 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.	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.	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.
Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination	99 Percentages of subjects Interval 96.0 to 100.0	100 Percentages of subjects Interval 93.0 to 100.0	—	—

SECONDARY outcome

Timeframe: Day 57 (28 days after last active vaccination)

Population: Analysis was done on the PP dataset.

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.

Outcome measures

Measure	R/JE - Acc n=157 Participants 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.	R - Conv n=204 Participants 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.	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.	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.
RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination	11 IU/mL Interval 9.0 to 12.0	9.9 IU/mL Interval 8.57 to 11.0	—	—

SECONDARY outcome

Timeframe: Day 57 (28 days after last active vaccination)

Population: Analysis was done on the PP dataset.

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.

Outcome measures

Measure	R/JE - Acc n=157 Participants 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.	R - Conv n=49 Participants 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.	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.	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.
PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination	291 Titers Interval 256.0 to 331.0	331 Titers Interval 265.0 to 415.0	—	—

SECONDARY outcome

Timeframe: Day 36 and day 57 (28 days after last active vaccination)

Population: Analysis was done on the PP set.

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.

Outcome measures

Measure	R/JE - Acc n=206 Participants 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.	R - Conv n=204 Participants 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.	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.	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.
Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination	99 Percentages of subjects Interval 96.0 to 100.0	100 Percentages of subjects Interval 97.0 to 100.0	—	—

SECONDARY outcome

Timeframe: Day 15 and day 36 (28 after last active vaccination)

Population: Analysis was done on the PP dataset.

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.

Outcome measures

Measure	R/JE - Acc n=209 Participants 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.	R - Conv n=47 Participants 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.	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.	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.
Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination	99 Percentages of subjects Interval 96.0 to 100.0	100 Percentages of subjects Interval 92.0 to 100.0	—	—

SECONDARY outcome

Timeframe: Day 1, 8, 15, 36, 57, 91, 181 and Day 366

Population: Analysis was done on the PP dataset.

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.

Outcome measures

Measure	R/JE - Acc n=166 Participants 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.	R - Conv n=215 Participants 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.	R - Conv n=218 Participants 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.	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.
Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL Day 1	1 Percentages of subjects Interval 0.015 to 3.0	1 Percentages of subjects Interval 0.0 to 3.0	1 Percentages of subjects Interval 0.0 to 4.0	—
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 Interval 2.0 to 9.0	16 Percentages of subjects Interval 11.0 to 21.0	4 Percentages of subjects Interval 2.0 to 8.0	—
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 Interval 96.0 to 100.0	100 Percentages of subjects Interval 97.0 to 100.0	99 Percentages of subjects Interval 97.0 to 100.0	—
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 Interval 98.0 to 100.0	99 Percentages of subjects Interval 96.0 to 100.0	100 Percentages of subjects Interval 97.0 to 100.0	—
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 Interval 98.0 to 100.0	97 Percentages of subjects Interval 93.0 to 99.0	100 Percentages of subjects Interval 97.0 to 100.0	—
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 Interval 95.0 to 100.0	85 Percentages of subjects Interval 79.0 to 90.0	98 Percentages of subjects Interval 95.0 to 99.0	—
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 Interval 82.0 to 92.0	75 Percentages of subjects Interval 68.0 to 81.0	89 Percentages of subjects Interval 84.0 to 93.0	—
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 Interval 68.0 to 82.0	68 Percentages of subjects Interval 61.0 to 74.0	80 Percentages of subjects Interval 74.0 to 85.0	—

SECONDARY outcome

Timeframe: Day 1, 8, 15, 36, 57, 91, 181, and 366

Population: Analysis was done on the PP dataset.

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.

Outcome measures

Measure	R/JE - Acc n=166 Participants 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.	R - Conv n=215 Participants 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.	R - Conv n=218 Participants 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.	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.
Kinetics of Rabies Immune Response Measured as the RVNA GMCs Day 1	0.052 IU/mL Interval 0.048 to 0.056	0.053 IU/mL Interval 0.049 to 0.056	0.054 IU/mL Interval 0.05 to 0.057	—
Kinetics of Rabies Immune Response Measured as the RVNA GMCs Day 8 (N=161, 210, 213)	0.071 IU/mL Interval 0.061 to 0.084	0.13 IU/mL Interval 0.12 to 0.16	0.076 IU/mL Interval 0.066 to 0.088	—
Kinetics of Rabies Immune Response Measured as the RVNA GMCs Day 15 (N=161, 209, 210),	21 IU/mL Interval 17.0 to 25.0	26 IU/mL Interval 22.0 to 30.0	24 IU/mL Interval 20.0 to 28.0	—
Kinetics of Rabies Immune Response Measured as the RVNA GMCs Day 36 (N=157, 206, 207)	14 IU/mL Interval 12.0 to 17.0	5.75 IU/mL Interval 4.95 to 6.67	13 IU/mL Interval 11.0 to 15.0	—
Kinetics of Rabies Immune Response Measured as the RVNA GMCs Day 57 (N=157, 204, 204)	10 IU/mL Interval 8.72 to 12.0	3.01 IU/mL Interval 2.59 to 3.51	9.66 IU/mL Interval 8.31 to 11.0	—
Kinetics of Rabies Immune Response Measured as the RVNA GMCs Day 91 (N=152, 206, 204)	4.79 IU/mL Interval 3.98 to 5.76	1.63 IU/mL Interval 1.39 to 1.91	5.04 IU/mL Interval 4.29 to 5.91	—
Kinetics of Rabies Immune Response Measured as the RVNA GMCs Day 181 (N= 155, 200, 202)	1.86 IU/mL Interval 1.15 to 2.3	1 IU/mL Interval 0.83 to 1.21	2.04 IU/mL Interval 1.69 to 2.46	—
Kinetics of Rabies Immune Response Measured as the RVNA GMCs Day 366 (N=154, 199, 204)	0.93 IU/mL Interval 0.75 to 1.16	0.82 IU/mL Interval 0.67 to 1.0	1.14 IU/mL Interval 0.94 to 1.38	—

SECONDARY outcome

Timeframe: Days 1, 15, 22, 36, 57, 91, 181 and 366

Population: Analysis was done on the PP dataset.

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).

Outcome measures

Measure	R/JE - Acc n=165 Participants 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.	R - Conv n=215 Participants 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.	R - Conv n=55 Participants 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.	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.
Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 Day 1	1 Percentages of subjects Interval 0.0 to 4.0	6 Percentages of subjects Interval 3.0 to 10.0	9 Percentages of subjects Interval 3.0 to 20.0	—
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 Analysis was not performed in this group at this timepoint.	99 Percentages of subjects Interval 96.0 to 100.0	NA Percentages of subjects Analysis was not performed in this group at this timepoint.	—
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 Analysis was not performed in this group at this timepoint.	100 Percentages of subjects Interval 97.0 to 100.0	NA Percentages of subjects Analysis was not performed in this group at this timepoint.	—
Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 Day 36 (157, 206, 47)	99 Percentages of subjects Interval 97.0 to 100.0	99 Percentages of subjects Interval 96.0 to 100.0	100 Percentages of subjects Interval 92.0 to 100.0	—
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 Interval 98.0 to 100.0	98 Percentages of subjects Interval 95.0 to 99.0	100 Percentages of subjects Interval 93.0 to 100.0	—
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 Analysis was not performed in this group at this timepoint.	98 Percentages of subjects Interval 95.0 to 99.0	NA Percentages of subjects Analysis was not performed in this group at this timepoint.	—
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 Interval 88.0 to 97.0	98 Percentages of subjects Interval 94.0 to 99.0	92 Percentages of subjects Interval 80.0 to 98.0	—
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 Interval 79.0 to 91.0	94 Percentages of subjects Interval 90.0 to 97.0	88 Percentages of subjects Interval 75.0 to 95.0	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	R/JE - Acc n=165 Participants 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.	R - Conv n=215 Participants 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.	R - Conv n=55 Participants 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.	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.
Kinetics of JE Immune Response Measured as PRNT50 GMTs Day 1	5.13 Titers Interval 4.84 to 5.43	5.63 Titers Interval 5.35 to 5.92	5.73 Titers Interval 5.2 to 6.33	—
Kinetics of JE Immune Response Measured as PRNT50 GMTs Day 15 (N=0, 209, 0)	NA Titers Analysis was not performed in this group at this timepoint.	715 Titers Interval 608.0 to 842.0	NA Titers Analysis was not performed in this group at this timepoint.	—
Kinetics of JE Immune Response Measured as PRNT50 GMTs Day 22 (0, 208, 0)	NA Titers Analysis was not performed in this group at this timepoint.	1255 Titers Interval 1068.0 to 1475.0	NA Titers Analysis was not performed in this group at this timepoint.	—
Kinetics of JE Immune Response Measured as PRNT50 GMTs Day 36 (N=157, 206, 47)	292 Titers Interval 247.0 to 346.0	690 Titers Interval 595.0 to 801.0	376 Titers Interval 277.0 to 510.0	—
Kinetics of JE Immune Response Measured as PRNT50 GMTs Day 57 (N= 157, 204, 49)	299 Titers Interval 254.0 to 352.0	372 Titers Interval 322.0 to 430.0	337 Titers Interval 252.0 to 451.0	—
Kinetics of JE Immune Response Measured as PRNT50 GMTs Day 91 (N=0, 206, 0)	NA Titers Analysis was not performed in this group at this timepoint.	228 Titers Interval 192.0 to 272.0	NA Titers Analysis was not performed in this group at this timepoint.	—
Kinetics of JE Immune Response Measured as PRNT50 GMTs Day 181 (N=155, 200, 49)	63 Titers Interval 53.0 to 75.0	151 Titers Interval 130.0 to 176.0	64 Titers Interval 47.0 to 87.0	—
Kinetics of JE Immune Response Measured as PRNT50 GMTs Day 366 (N=154, 199, 48)	39 Titers Interval 33.0 to 47.0	117 Titers Interval 100.0 to 137.0	39 Titers Interval 28.0 to 54.0	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	R/JE - Acc n=166 Participants 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.	R - Conv n=217 Participants 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.	R - Conv n=220 Participants 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.	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.
Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination Erythema (day 4 to 10)	NA Number of subjects Subjects in this group received placebo at day 4	17 Number of subjects	NA Number of subjects Subjects in this group received placebo at day 4	—
Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination Pain (day 4 to 10)	NA Number of subjects Subjects in this group received placebo at day 4	55 Number of subjects	NA Number of subjects Subjects in this group received placebo at day 4	—
Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination Pain (day 1 to 7)	43 Number of subjects	69 Number of subjects	72 Number of subjects	—
Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination Erythema (day 8 to 14)	8 Number of subjects	31 Number of subjects	29 Number of subjects	—
Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination Induration (day 8 to 14)	10 Number of subjects	15 Number of subjects	17 Number of subjects	—
Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination Pain (day 8 to 14)	57 Number of subjects	87 Number of subjects	90 Number of subjects	—
Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination Erythema (day 29 to 35)	23 Number of subjects	NA Number of subjects Subjects in this group received placebo at day 29	45 Number of subjects	—
Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination Induration (day 29 to 35)	18 Number of subjects	NA Number of subjects Subjects in this group received placebo at day 29	32 Number of subjects	—
Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination Pain (day 29 to 35)	52 Number of subjects	NA Number of subjects Subjects in this group received placebo at day 29	87 Number of subjects	—
Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination Erythema (day 1 to 7)	13 Number of subjects	31 Number of subjects	28 Number of subjects	—
Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination Induration (day 1 to 7)	3 Number of subjects	16 Number of subjects	11 Number of subjects	—
Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination Induration (day 4 to 10)	NA Number of subjects Subjects in this group received placebo at day 4	9 Number of subjects	NA Number of subjects Subjects in this group received placebo at day 4	—

SECONDARY outcome

Timeframe: Day 1 through day 7 after each vaccination (on day 1, 8 and 29)

Population: Analysis was done on the solicited safety set.

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).

Outcome measures

Measure	R/JE - Acc n=166 Participants 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.	R - Conv n=217 Participants 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.	R - Conv n=56 Participants 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.	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.
Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination Induration (day 29 to 35)	5 Number of subjects	NA Number of subjects Subjects in this group didn't receive JE vaccination on day 29.	4 Number of subjects	—
Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination Pain (day 29 to 35)	46 Number of subjects	NA Number of subjects Subjects in this group didn't receive JE vaccination on day 29.	12 Number of subjects	—
Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination Erythema (day 1 to 7)	20 Number of subjects	30 Number of subjects	6 Number of subjects	—
Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination Induration (day 1 to 7)	13 Number of subjects	19 Number of subjects	5 Number of subjects	—
Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination Induration (day 8 to 14)	NA Number of subjects Subjects in this group didn't receive JE vaccination on day 8.	12 Number of subjects	NA Number of subjects Subjects in this group didn't receive JE vaccination on day 8.	—
Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination Pain (day 8 to 14)	NA Number of subjects Subjects in this group didn't receive JE vaccination on day 8.	60 Number of subjects	NA Number of subjects Subjects in this group didn't receive JE vaccination on day 8.	—
Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination Pain (day 1 to 7)	82 Number of subjects	102 Number of subjects	26 Number of subjects	—
Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination Erythema (day 8 to 14)	NA Number of subjects Subjects in this group didn't receive JE vaccination on day 8.	18 Number of subjects	NA Number of subjects Subjects in this group didn't receive JE vaccination on day 8.	—
Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination Erythema (day 29 to 35)	12 Number of subjects	NA Number of subjects Subjects in this group didn't receive JE vaccination on day 29.	5 Number of subjects	—

SECONDARY outcome

Timeframe: Day 1 through day 7 after each injection (day 1, 4, 8 and 29)

Population: Analysis was done on the solicited safety set.

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).

Outcome measures

Measure	R/JE - Acc n=163 Participants 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.	R - Conv n=213 Participants 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.	R - Conv n=220 Participants 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.	JE - Conv n=56 Participants 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.
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 Subjects in this group received only 1 dose of placebo at day 8.	NA Number of Subjects Subjects in this group didn't receive placebo at day 8.	NA Number of Subjects Subjects in this group received only 1 dose of placebo at day 8.	3 Number of Subjects
Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection Erythema (day 1 to 7)	NA Number of Subjects Subjects in this group didn't receive placebo at day 1.	NA Number of Subjects Subjects in this group didn't receive placebo at day 1.	20 Number of Subjects	3 Number of Subjects
Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection Induration (day 1 to 7)	NA Number of Subjects Subjects in this group didn't receive placebo at day 1.	NA Number of Subjects Subjects in this group didn't receive placebo at day 1.	4 Number of Subjects	5 Number of Subjects
Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection Pain (day 1 to 7)	NA Number of Subjects Subjects in this group didn't receive placebo at day 1.	NA Number of Subjects Subjects in this group didn't receive placebo at day 1.	26 Number of Subjects	7 Number of Subjects
Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection Erythema (day 4 to 10)	8 Number of Subjects	NA Number of Subjects Subjects in this group didn't receive placebo at day 4.	13 Number of Subjects	3 Number of Subjects
Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection Induration (day 4 to 10)	1 Number of Subjects	NA Number of Subjects Subjects in this group didn't receive placebo at day 4.	4 Number of Subjects	2 Number of Subjects
Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection Pain (day 4 to 10)	7 Number of Subjects	NA Number of Subjects Subjects in this group didn't receive placebo at day 4.	15 Number of Subjects	3 Number of Subjects
Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection Erythema (day 8 to 14)	1 Number of Subjects	NA Number of Subjects Subjects in this group didn't receive placebo at day 8.	11 Number of Subjects	4 Number of Subjects
Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection Induration (day 8 to 14)	0 Number of Subjects	NA Number of Subjects Subjects in this group didn't receive placebo at day 8.	5 Number of Subjects	1 Number of Subjects
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 Subjects in this group received only 1 dose of placebo at day 8.	NA Number of Subjects Subjects in this group didn't receive placebo at day 8.	NA Number of Subjects Subjects in this group received only 1 dose of placebo at day 8.	1 Number of Subjects
Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection Pain (day 8 to 14)	19 Number of Subjects	NA Number of Subjects Subjects in this group didn't receive placebo at day 8.	20 Number of Subjects	3 Number of Subjects
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 Subjects in this group received only 1 dose of placebo at day 8.	NA Number of Subjects Subjects in this group didn't receive placebo at day 8.	NA Number of Subjects Subjects in this group received only 1 dose of placebo at day 8.	5 Number of Subjects
Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection Erythema (day 29 to 35)	NA Number of Subjects Subjects in this group didn't receive placebo at day 29.	15 Number of Subjects	15 Number of Subjects	3 Number of Subjects
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 Subjects in this group didn't receive placebo at day 29.	14 Number of Subjects	NA Number of Subjects Subjects in this group received only 1 dose of placebo at day 29.	NA Number of Subjects Subjects in this group received only 1 dose of placebo at day 29.
Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection Induration (day 29 to 35)	NA Number of Subjects Subjects in this group didn't receive placebo at day 29.	6 Number of Subjects	4 Number of Subjects	1 Number of Subjects
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 Subjects in this group didn't receive placebo at day 29.	4 Number of Subjects	NA Number of Subjects Subjects in this group received only 1 dose of placebo at day 29.	NA Number of Subjects Subjects in this group received only 1 dose of placebo at day 29.
Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection Pain (day 29 to 35)	NA Number of Subjects Subjects in this group didn't receive placebo at day 29.	15 Number of Subjects	28 Number of Subjects	3 Number of Subjects
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 Subjects in this group didn't receive placebo at day 29.	19 Number of Subjects	NA Number of Subjects Subjects in this group received only 1 dose of placebo at day 29.	NA Number of Subjects Subjects in this group received only 1 dose of placebo at day 29.

SECONDARY outcome

Timeframe: Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29)

Population: Analysis was done on the solicited safety set.

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.

Outcome measures

Measure	R/JE - Acc n=166 Participants 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.	R - Conv n=217 Participants 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.	R - Conv n=220 Participants 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.	JE - Conv n=56 Participants 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.
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	56 Number of Subjects	46 Number of Subjects	16 Number of Subjects
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	46 Number of Subjects	38 Number of Subjects	14 Number of Subjects
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	55 Number of Subjects	31 Number of Subjects	7 Number of Subjects
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	13 Number of Subjects	7 Number of Subjects	1 Number of Subjects
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	8 Number of Subjects	12 Number of Subjects	6 Number of Subjects
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	7 Number of Subjects	13 Number of Subjects	4 Number of Subjects
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	2 Number of Subjects	2 Number of Subjects	0 Number of Subjects
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	11 Number of Subjects	8 Number of Subjects	3 Number of Subjects
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	30 Number of Subjects	33 Number of Subjects	5 Number of Subjects
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	28 Number of Subjects	29 Number of Subjects	3 Number of Subjects
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	19 Number of Subjects	14 Number of Subjects	1 Number of Subjects
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	9 Number of Subjects	9 Number of Subjects	0 Number of Subjects
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	8 Number of Subjects	9 Number of Subjects	2 Number of Subjects
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	5 Number of Subjects	8 Number of Subjects	0 Number of Subjects
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	1 Number of Subjects	2 Number of Subjects	0 Number of Subjects
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	10 Number of Subjects	15 Number of Subjects	2 Number of Subjects
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	47 Number of Subjects	47 Number of Subjects	6 Number of Subjects
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	43 Number of Subjects	41 Number of Subjects	3 Number of Subjects
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	41 Number of Subjects	38 Number of Subjects	1 Number of Subjects
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	9 Number of Subjects	13 Number of Subjects	1 Number of Subjects
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	14 Number of Subjects	13 Number of Subjects	2 Number of Subjects
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	14 Number of Subjects	16 Number of Subjects	2 Number of Subjects
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	1 Number of Subjects	5 Number of Subjects	0 Number of Subjects
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	17 Number of Subjects	20 Number of Subjects	2 Number of Subjects
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	29 Number of Subjects	36 Number of Subjects	3 Number of Subjects
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	22 Number of Subjects	40 Number of Subjects	4 Number of Subjects
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	15 Number of Subjects	28 Number of Subjects	2 Number of Subjects
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	6 Number of Subjects	14 Number of Subjects	1 Number of Subjects
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	2 Number of Subjects	1 Number of Subjects	0 Number of Subjects
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	10 Number of Subjects	11 Number of Subjects	3 Number of Subjects
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	8 Number of Subjects	9 Number of Subjects	2 Number of Subjects
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	12 Number of Subjects	9 Number of Subjects	2 Number of Subjects

SECONDARY outcome

Timeframe: 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.

Safety was assessed as the number of subjects who reported unsolicited AEs after any vaccination given according to accelerated and conventional schedule.

Outcome measures

Measure	R/JE - Acc n=166 Participants 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.	R - Conv n=217 Participants 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.	R - Conv n=220 Participants 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.	JE - Conv n=56 Participants 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.
Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 Any AE	69 Number of subjects	108 Number of subjects	110 Number of subjects	29 Number of subjects
Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 SAEs	2 Number of subjects	3 Number of subjects	2 Number of subjects	3 Number of subjects
Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 AEs leading to premature withdrawal	1 Number of subjects	0 Number of subjects	0 Number of subjects	1 Number of subjects

Adverse Events

R/JE - Conv

Serious events: 2 serious events

Other events: 138 other events

Deaths: 0 deaths

R/JE - Acc

Serious events: 3 serious events

Other events: 186 other events

Deaths: 0 deaths

R - Conv

Serious events: 2 serious events

Other events: 185 other events

Deaths: 0 deaths

JE - Conv

Serious events: 3 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Measure	R/JE - Conv n=166 participants at risk Subjects received Rabies and JE vaccines, conventional schedule, i.e. 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.	R/JE - Acc n=217 participants at risk Subjects received Rabies and JE vaccines, accelerated schedule, i.e. 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.	R - Conv n=220 participants at risk Subjects received Rabies vaccine, conventional schedule, i.e. 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.	JE - Conv n=56 participants at risk Subjects received JE vaccine, conventional schedule, i.e. 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.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.45% 1/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Cardiac disorders TACHYCARDIA	0.00% 0/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.45% 1/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Eye disorders EYELID OEDEMA	0.00% 0/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	1.8% 1/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Gastrointestinal disorders PANCREATITIS ACUTE	0.00% 0/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.46% 1/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Hepatobiliary disorders CHOLECYSTITIS	0.00% 0/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	1.8% 1/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Hepatobiliary disorders CHOLELITHIASIS	0.00% 0/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	1.8% 1/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.60% 1/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Injury, poisoning and procedural complications MENISCUS INJURY	0.00% 0/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.46% 1/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OVARIAN GERM CELL TERATOMA BENIGN	0.00% 0/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.46% 1/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Nervous system disorders SYNCOPE	0.00% 0/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.45% 1/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Psychiatric disorders ALCOHOL WITHDRAWAL SYNDROME	0.00% 0/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	1.8% 1/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Psychiatric disorders DEPRESSION	0.60% 1/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Skin and subcutaneous tissue disorders PRURITUS GENERALISED	0.00% 0/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	0.00% 0/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	1.8% 1/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.

Other adverse events

Measure	R/JE - Conv n=166 participants at risk Subjects received Rabies and JE vaccines, conventional schedule, i.e. 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.	R/JE - Acc n=217 participants at risk Subjects received Rabies and JE vaccines, accelerated schedule, i.e. 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.	R - Conv n=220 participants at risk Subjects received Rabies vaccine, conventional schedule, i.e. 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.	JE - Conv n=56 participants at risk Subjects received JE vaccine, conventional schedule, i.e. 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.
Gastrointestinal disorders NAUSEA	11.4% 19/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	14.3% 31/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	15.9% 35/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	16.1% 9/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
General disorders FATIGUE	32.5% 54/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	42.9% 93/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	38.2% 84/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	33.9% 19/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
General disorders INJECTION SITE ERYTHEMA	28.9% 48/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	33.6% 73/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	38.6% 85/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	23.2% 13/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
General disorders INJECTION SITE INDURATION	17.5% 29/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	19.8% 43/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	21.8% 48/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	17.9% 10/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
General disorders INJECTION SITE PAIN	69.3% 115/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	67.3% 146/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	59.5% 131/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	55.4% 31/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Infections and infestations NASOPHARYNGITIS	13.3% 22/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	15.2% 33/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	14.5% 32/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	12.5% 7/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Metabolism and nutrition disorders DECREASED APPETITE	11.4% 19/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	11.1% 24/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	12.3% 27/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	16.1% 9/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Musculoskeletal and connective tissue disorders ARTHRALGIA	7.8% 13/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	13.4% 29/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	14.1% 31/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	5.4% 3/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Musculoskeletal and connective tissue disorders MYALGIA	30.1% 50/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	34.6% 75/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	27.3% 60/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	17.9% 10/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.
Nervous system disorders HEADACHE	38.0% 63/166 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	43.3% 94/217 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	43.2% 95/220 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.	33.9% 19/56 • Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected. Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.

Additional Information

Posting Director

Novartis Vaccines

Email: RegistryContactVaccinesUS@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60