Safety and Immunogenicity of 2 Different Vaccination Sche... | NCT01662440

NCT01662440

ID	Type	Description	Link
2011-005173-23	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
R/JE - Conv	Active Comparator	Subjects received Rabies and Japanese Encephalitis (JE) vaccines following the 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.	Biological: Rabies Biological: Japanese Encephalitis Other: Placebo
R/JE - Acc	Experimental	Subjects received Rabies and JE vaccines following the 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.	Biological: Rabies Biological: Japanese Encephalitis Other: Placebo
R - Conv	Active Comparator	Subjects received Rabies vaccine following the 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.	Biological: Rabies Other: Placebo
JE - Conv	Active Comparator	Subjects received JE vaccine following the 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.	Biological: Japanese Encephalitis

Name	Type	Description	Arm Group Labels	Other Names
Rabies	Biological	Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).	R - Conv R/JE - Acc R/JE - Conv

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination	Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule. As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.	Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule)
Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination	Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule. As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.	Day 28 after last active vaccination (day 36 - group that received accelerated schedule, day 57 - group that received conventional schedule)

Secondary Outcomes

Measure	Description	Time Frame
RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination	Immune response was measured as the RVNA GMCs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule. Data were adjusted using ANOVA model, as per protocol specification.	Day 57 (28 days after last active vaccination)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis Vaccines and Diagnostics	Novartis Vaccines	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Specific Prophylaxis and Tropical Medicine Center for Pathophysiology, Infectious Diseases and Immunology Medical University of Vienna		Kinderspitalgasse 15	State of Vienna	A-1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26994987	Derived	Cramer JP, Jelinek T, Paulke-Korinek M, Reisinger EC, Dieckmann S, Alberer M, Buhler S, Bosse D, Meyer S, Fragapane E, Costantini M, Pellegrini M, Lattanzi M, Dovali C. One-year immunogenicity kinetics and safety of a purified chick embryo cell rabies vaccine and an inactivated Vero cell-derived Japanese encephalitis vaccine administered concomitantly according to a new, 1-week, accelerated primary series. J Travel Med. 2016 Mar 19;23(3):taw011. doi: 10.1093/jtm/taw011. Print 2016 Mar.
26005163

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	R/JE - Acc

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	R/JE - Conv	Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
BG001	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.
BG002	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.
BG003	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.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG000167 BG001217 BG002221 BG00356 BG004661

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

year

Title

Denominators

Categories

Title	Measurements
	OG000100(97 to 100) OG001100(97 to 100)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	To establish non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) accelerated schedule as compared to conventional schedule at 7 days after last active vaccination.					Difference in percentages of subjects	0			2-Sided	97.5	-2.8	2.8				Yes	Non-Inferiority or Equivalence	The immune response of accelerated schedule of the Rabies vaccine considered non-inferior to the conventional schedule if the lower bound of the two-sided 97.5% Confidence Intervals (CI) of the difference in the percentages of subjects with RVNA titer ≥0.5 IU/mL measured 7 days after last active vaccination is greater than -5.

Primary

Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination

Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule.

As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.

Analysis was done on the PP dataset.

Posted

Number

95% Confidence Interval

Percentages of subjects

Day 28 after last active vaccination (day 36 - group that received accelerated schedule, day 57 - group that received conventional schedule)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination

Immune response was measured as the RVNA GMCs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.

Data were adjusted using ANOVA model, as per protocol specification.

Analysis was done on the PP dataset.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

Day 57 (28 days after last active vaccination)

ID	Title	Description
OG000	R/JE - Conv	Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
OG001	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.

Units	Counts
Participants

Secondary

PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination

Immune response was measured as the PRNT50 GMTs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.

Data were adjusted using ANOVA model, as per protocol specifications.

Analysis was done on the PP dataset.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 57 (28 days after last active vaccination)

ID	Title	Description
OG000	R/JE - Conv	Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
OG001	JE - Conv	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.

Units	Counts
Participants

Secondary

Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination

Immune response was measured as the percentages of subjects with RVNA concentration ≥0.5 IU/mL 28 days after last active vaccination, ie, day 36 for the group that received the accelerated schedule and day 57 for the group that received the conventional schedule.

As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.

Analysis was done on the PP set.

Posted

Number

95% Confidence Interval

Percentages of subjects

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination

Immune response was measured as the percentage of subjects with PRNT50 titer of ≥1:10 7 days after last active vaccination, ie, day 15 for the group that received the accelerated schedule and day 36 for the group that received the conventional schedule.

As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.

Analysis was done on the PP dataset.

Posted

Number

95% Confidence Interval

Percentages of subjects

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

ID	Title	Description
OG000	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.
OG001	JE - Conv	Group Description 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.

Units	Counts

Secondary

Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL

To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the percentage of subjects with RVNA concentrations ≥0.5 IU/mL on days 1, 8, 15, 36, 57, 91, 181, and 366.

Analysis was done on the PP dataset.

Posted

Number

95% Confidence Interval

Percentages of subjects

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

ID	Title	Description
OG000	R/JE - Conv	Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
OG001	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.
OG002	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.

Secondary

Kinetics of Rabies Immune Response Measured as the RVNA GMCs

To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the RVNA GMCs on days 1, 8, 15, 36, 57, 91, 181, and 366.

Analysis was done on the PP dataset.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

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

ID	Title	Description
OG000	R/JE - Conv	Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
OG001	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.
OG002	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.

Secondary

Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10

To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the percentage of subjects with PRNT50 titer ≥1:10 on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).

Analysis was done on the PP dataset.

Posted

Number

95% Confidence Interval

Percentages of subjects

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

ID	Title	Description
OG000	R/JE - Conv	Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
OG001	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.
OG002	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.

Secondary

Kinetics of JE Immune Response Measured as PRNT50 GMTs

To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the PRNT50 GMTs on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).

Analysis was done on the PP dataset.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule)

ID	Title	Description
OG000	R/JE - Conv	Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
OG001	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.
OG002	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.

Secondary

Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination

Safety was assessed as the number of subjects who reported solicited local adverse events (AEs) after each rabies vaccination given according to accelerated or conventional schedule as follows: from day 1 through day 7 (vaccination on day 1; all Rabies groups), day 4 through day 10 (vaccination on day 4; in R/JE - Acc group only), day 8 through day 14 (vaccination on day 8; all Rabies groups), or day 29 through day 35 (vaccination on day 29; R/JE - Conv and R - Conv groups).

Analysis was done on the solicited safety set, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.

Posted

Number

Number of subjects

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

ID	Title	Description
OG000	R/JE - Conv	Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
OG001	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.
OG002

Secondary

Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination

Safety was assessed as the number of subjects who reported solicited local AEs after each JE vaccination given according to accelerated or conventional schedule as follow: from day 1 through day 7 (vaccination on day 1; all JE groups), day 8 through day 14 (vaccination on day 8; R/JE - Acc group only), or day 29 through day 35 (vaccination on day 29; R/JE - Con and JE - Conv groups).

Analysis was done on the solicited safety set.

Posted

Number

Number of subjects

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

ID	Title	Description
OG000	R/JE - Conv	Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
OG001	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.
OG002	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.

Secondary

Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection

Safety was assessed as the number of subjects who reported solicited local AEs after each placebo injection given according to accelerated and conventional schedule as follow: from day 1 through day 7 (injection on day 1; R - Conv and JE - Conv groups), day 4 through day 10 (injection on day 4; in R/JE - Conv, R - Conv and JE - Conv groups), day 8 through day 14 (injection on day 8; in R/JE - Conv, R - Conv and JE - Conv groups), and day 29 through day 35 (injection on day 29; R/JE - Acc, R - Con and JE - Conv groups).

Analysis was done on the solicited safety set.

Posted

Number

Number of Subjects

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

ID	Title	Description
OG000	R/JE - Conv	Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
OG001	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.
OG002	R - Conv

Secondary

Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination

Safety was assessed as the number of subjects who reported solicited systemic AEs and other indicators of reactogenicity after each vaccination given according to accelerated and conventional schedule.

Analysis was done on the solicited safety set.

Posted

Number

Number of Subjects

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

ID	Title	Description
OG000	R/JE - Conv	Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
OG001	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.
OG002	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.

Secondary

Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57

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

Analysis was done on the unsolicited safety set, ie, the subjects in the exposed population who provided postvaccination unsolicited safety data.

Posted

Number

Number of subjects

Day 1 through Day 57

ID	Title	Description
OG000	R/JE - Conv	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.
OG001	R/JE - Acc	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.
OG002	R - Conv	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.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	R/JE - Conv	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.	2	166	138	166
EG001	R/JE - Acc	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.	3	217	186	217
EG002	R - Conv	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.	2	220	185	220
EG003	JE - Conv	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.	3	56	45	56

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected166 at risk EG0010 affected217 at risk EG0021 affected220 at risk EG0030 affected56 at risk
TACHYCARDIA	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected166 at risk EG0010 affected217 at risk EG0021 affected220 at risk EG003
EYELID OEDEMA	Eye disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected166 at risk EG0010 affected217 at risk EG0020 affected220 at risk EG003
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected166 at risk EG0011 affected217 at risk EG0020 affected220 at risk EG003
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected166 at risk EG0010 affected217 at risk EG0020 affected220 at risk EG003
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected166 at risk EG0010 affected217 at risk EG0020 affected220 at risk EG003
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0001 affected166 at risk EG0010 affected217 at risk EG0020 affected220 at risk EG003
MENISCUS INJURY	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0000 affected166 at risk EG0011 affected217 at risk EG0020 affected220 at risk EG003
OVARIAN GERM CELL TERATOMA BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0000 affected166 at risk EG0011 affected217 at risk EG0020 affected220 at risk EG003
SYNCOPE	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected166 at risk EG0010 affected217 at risk EG0021 affected220 at risk EG003
ALCOHOL WITHDRAWAL SYNDROME	Psychiatric disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected166 at risk EG0010 affected217 at risk EG0020 affected220 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected166 at risk EG0010 affected217 at risk EG0020 affected220 at risk EG003
PRURITUS GENERALISED	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected166 at risk EG0010 affected217 at risk EG0020 affected220 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
NAUSEA	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG00019 affected166 at risk EG00131 affected217 at risk EG00235 affected220 at risk EG0039 affected56 at risk
FATIGUE	General disorders	MedDRA (17.0)	Systematic Assessment	EG00054 affected166 at risk EG00193 affected217 at risk EG00284 affected220 at risk EG003
INJECTION SITE ERYTHEMA	General disorders	MedDRA (17.0)	Systematic Assessment	EG00048 affected166 at risk EG00173 affected217 at risk EG00285 affected220 at risk EG003
INJECTION SITE INDURATION	General disorders	MedDRA (17.0)	Systematic Assessment	EG00029 affected166 at risk EG00143 affected217 at risk EG00248 affected220 at risk EG003
INJECTION SITE PAIN	General disorders	MedDRA (17.0)	Systematic Assessment	EG000115 affected166 at risk EG001146 affected217 at risk EG002131 affected220 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA (17.0)	Non-systematic Assessment	EG00022 affected166 at risk EG00133 affected217 at risk EG00232 affected220 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG00019 affected166 at risk EG00124 affected217 at risk EG00227 affected220 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG00013 affected166 at risk EG00129 affected217 at risk EG00231 affected220 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG00050 affected166 at risk EG00175 affected217 at risk EG00260 affected220 at risk EG003
HEADACHE	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG00063 affected166 at risk EG00194 affected217 at risk EG00295 affected220 at risk EG003

ID	Term
D011818	Rabies
D004672	Encephalitis, Japanese

Ancestor Terms

ID	Term
D018353	Rhabdoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections
D004671	Encephalitis, Arbovirus
D018792	Encephalitis, Viral
D020805	Central Nervous System Viral Diseases
D002494	Central Nervous System Infections
D000069544	Infectious Encephalitis
D001102	Arbovirus Infections
D000079426	Vector Borne Diseases
D000096724	Mosquito-Borne Diseases
D018177	Flavivirus Infections
D018178	Flaviviridae Infections
D004660	Encephalitis
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D000090862	Neuroinflammatory Diseases

Units	Counts
Participants	OG000209 OG00149

Units	Counts
Participants	OG000166 OG001215 OG002218

Subjects in this group received only 1 dose of placebo at day 29.