Trial Outcomes & Findings for Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese Toddlers (NCT NCT01188343)

Last Updated: 2014-08-15

Results Overview

JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer \<1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is \<120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is \<10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is \<10 U/ml.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

542 participants

Primary outcome timeframe

Day 0 (pre-vaccination) and Day 42 post-vaccination

Results posted on

2014-08-15

Participant Flow

Study participants were enrolled from 14 August 2010 through 28 July 2011 at 5 clinic centers in Taiwan.

A total of 550 participants who met all of the inclusion and none of the exclusion criteria were randomized, 542 were vaccinated and reported.

Participant milestones

Participant milestones
Measure	JE CV + MMR (Group 1) Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42	MMR + JE CV (Group 2) Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42	JE CV/MMR (Group 3) Participants 12 to 18 months of age received one dose each of MMR and JE CV vaccine on day 0
Overall Study STARTED	102	219	221
Overall Study COMPLETED	101	193	220
Overall Study NOT COMPLETED	1	26	1

Reasons for withdrawal

Reasons for withdrawal
Measure	JE CV + MMR (Group 1) Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42	MMR + JE CV (Group 2) Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42	JE CV/MMR (Group 3) Participants 12 to 18 months of age received one dose each of MMR and JE CV vaccine on day 0
Overall Study Not vaccinated	0	2	1
Overall Study Withdrawal by Subject	1	24	0

Baseline Characteristics

Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese Toddlers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	JE CV + MMR (Group 1) n=102 Participants Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42	MMR + JE CV (Group 2) n=219 Participants Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42	JE CV/MMR (Group 3) n=221 Participants Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0	Total n=542 Participants Total of all reporting groups
Age, Categorical <=18 years	102 Participants n=5 Participants	219 Participants n=7 Participants	221 Participants n=5 Participants	542 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	13.1 Months STANDARD_DEVIATION 1.12 • n=5 Participants	13.0 Months STANDARD_DEVIATION 1.08 • n=7 Participants	13.1 Months STANDARD_DEVIATION 1.19 • n=5 Participants	13.1 Months STANDARD_DEVIATION 1.13 • n=4 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	110 Participants n=7 Participants	109 Participants n=5 Participants	265 Participants n=4 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	109 Participants n=7 Participants	112 Participants n=5 Participants	277 Participants n=4 Participants
Region of Enrollment Taiwan	102 Participants n=5 Participants	219 Participants n=7 Participants	221 Participants n=5 Participants	542 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 42 post-vaccination

Population: Seroconversion was assessed in the Per Protocol Analysis Set with evaluable data.

Outcome measures

Outcome measures
Measure	JE-CV + MMR (Group 1) n=95 Participants Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42	MMR + JE-CV (Group 2) n=176 Participants Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42	JE-CV/MMR (Group 3) n=197 Participants Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination Rubella (N = 0, 154, 178)	NA Percentage of Participants MMR was not administered on Day 0 in this group.	99.4 Percentage of Participants Interval 0.0 to 0.0	99.4 Percentage of Participants Interval 0.0 to 0.0
Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination Measles (N = 0, 170, 193)	NA Percentage of Participants MMR was not administered on Day 0 in this group.	97.6 Percentage of Participants Interval 0.0 to 0.0	100 Percentage of Participants Interval 0.0 to 0.0
Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination JE-CV (N = 95, 0, 194)	97.9 Percentage of Participants	NA Percentage of Participants Interval 0.0 to 0.0 JE-CV was not administered on Day 0 in this group	96.9 Percentage of Participants Interval 0.0 to 0.0
Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination Mumps (N = 0, 173, 194)	NA Percentage of Participants MMR was not administered on Day 0 in this group.	98.8 Percentage of Participants Interval 0.0 to 0.0	99.5 Percentage of Participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Pre-vaccination and Day 42 post-vaccination

Population: Seroconversion to JE-CV and to MMR vaccine antigen was assessed in all participants who were randomized, vaccinated, who performed all protocol defined activities and has evaluable data (Per-protocol Analysis Set).

Outcome measures

Outcome measures
Measure	JE-CV + MMR (Group 1) n=95 Participants Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42	MMR + JE-CV (Group 2) n=176 Participants Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42	JE-CV/MMR (Group 3) n=197 Participants Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine JE-CV Pre-vaccination (N = 95, 158, 194)	0.0 Percentage of Participants	0.0 Percentage of Participants Interval 0.0 to 0.0	0.0 Percentage of Participants Interval 0.0 to 0.0
Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine JE-CV Post-vaccination (N = 95, 158, 194)	97.9 Percentage of Participants	100.0 Percentage of Participants Interval 0.0 to 0.0	96.9 Percentage of Participants Interval 0.0 to 0.0
Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Measles Pre-vaccination (N = 94, 176, 196)	4.3 Percentage of Participants	2.8 Percentage of Participants Interval 0.0 to 0.0	1.0 Percentage of Participants Interval 0.0 to 0.0
Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Measles Post-vaccination (N = 94, 176, 197)	97.9 Percentage of Participants	97.7 Percentage of Participants Interval 0.0 to 0.0	100.0 Percentage of Participants Interval 0.0 to 0.0
Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Mumps Pre-vaccination (N = 94, 176, 196)	1.1 Percentage of Participants	1.1 Percentage of Participants Interval 0.0 to 0.0	0.5 Percentage of Participants Interval 0.0 to 0.0
Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Mumps Post-vaccination (N = 94, 176, 197)	100.0 Percentage of Participants	98.9 Percentage of Participants Interval 0.0 to 0.0	99.5 Percentage of Participants Interval 0.0 to 0.0
Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Rubella Pre-vaccination (N = 94, 176, 196)	9.6 Percentage of Participants	11.9 Percentage of Participants Interval 0.0 to 0.0	8.7 Percentage of Participants Interval 0.0 to 0.0
Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Rubella Post-vaccination (N = 94, 176, 197)	100.0 Percentage of Participants	99.4 Percentage of Participants Interval 0.0 to 0.0	99.5 Percentage of Participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Pre-vaccination and up to Month 12 post-vaccination

Population: Seroprotection to JE-CV and to MMR vaccine antigen was assessed in all participants who were randomized, vaccinated and who performed all protocol defined activities the Full Analysis Set.

JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroprotection was defined as: for JE-CV - participants with a pre-vaccination titer \<1/10 (1/dil) and post-vaccination titer ≥1/10, (1/dil) or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is \<120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 units/ml when pre-vaccination titer is \<10 units/ml; and for Rubella, post-vaccination titer ≥1/10 IU/ml when pre-vaccination titer is \<10 IU/m

Outcome measures

Outcome measures
Measure	JE-CV + MMR (Group 1) n=102 Participants Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42	MMR + JE-CV (Group 2) n=217 Participants Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42	JE-CV/MMR (Group 3) n=221 Participants Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine JE-CV Pre-vaccination (N=102, 197, 221)	2 Participants	10 Participants	4 Participants
Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine JE-CV 6 months Post-vaccination (N=96, 191, 217)	92 Participants	190 Participants	203 Participants
Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine JE-CV 12 months Post-vaccination (N=89, 164, 193)	86 Participants	162 Participants	171 Participants
Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Measles Pre-vaccination (N = 101, 217, 219)	4 Participants	8 Participants	2 Participants
Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Measles 6 months Post-vaccination (N=96, 191, 217)	93 Participants	189 Participants	216 Participants
Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Measles 12 months Post-vaccination (N=89, 164, 193	87 Participants	163 Participants	192 Participants
Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Mumps Pre-vaccination (N=101, 217, 219)	1 Participants	2 Participants	2 Participants
Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Mumps 6 months Post-vaccination (N=96, 191, 217)	90 Participants	180 Participants	208 Participants
Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Mumps 12 months Post-vaccination (N=89, 164, 193)	82 Participants	153 Participants	176 Participants
Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Rubella Pre-vaccination (N=101, 217, 219)	10 Participants	23 Participants	19 Participants
Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Rubella 6 months Post-vaccination (N=96, 191, 217)	95 Participants	191 Participants	217 Participants
Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Rubella 12 months Post-vaccination (N=89, 164, 193	89 Participants	164 Participants	192 Participants

SECONDARY outcome

Timeframe: Pre-vaccination and Day 42 post-vaccination

Population: Geometric mean titers were assessed in the Per Protocol Analysis Set population with evaluable data.

JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	JE-CV + MMR (Group 1) n=95 Participants Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42	MMR + JE-CV (Group 2) n=176 Participants Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42	JE-CV/MMR (Group 3) n=197 Participants Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Rubella post-vaccination (N = 94, 176, 197)	78.0 Titers Interval 68.3 to 89.2	81.4 Titers Interval 73.7 to 89.9	69.6 Titers Interval 63.6 to 76.0
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine JE-CV pre-vaccination (N = 95, 158, 194)	5.00 Titers Interval 5.0 to 5.0	5.00 Titers Interval 5.0 to 5.0	5.00 Titers Interval 5.0 to 5.0
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine JE-CV post-vaccination (N = 95, 158, 194)	510 Titers Interval 356.0 to 731.0	581 Titers Interval 449.0 to 752.0	332 Titers Interval 258.0 to 426.0
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Measles pre-vaccination (N = 94, 176, 196)	34.3 Titers Interval 31.5 to 37.3	33.4 Titers Interval 31.4 to 35.5	33.4 Titers Interval 32.0 to 35.0
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Measles post-vaccination (N = 94, 176, 197)	1835 Titers Interval 1536.0 to 2193.0	1723 Titers Interval 1506.0 to 1971.0	1924 Titers Interval 1753.0 to 2111.0
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Mumps pre-vaccination (N = 94, 176, 196)	2.59 Titers Interval 2.46 to 2.71	2.63 Titers Interval 2.52 to 2.75	2.55 Titers Interval 2.49 to 2.62
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Mumps Post-vaccination (N = 94, 176, 197)	81.1 Titers Interval 70.1 to 93.9	87.5 Titers Interval 77.6 to 98.8	89.2 Titers Interval 80.0 to 99.5
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Rubella pre-vaccination (N = 94, 176, 196)	3.90 Titers Interval 3.44 to 4.43	3.97 Titers Interval 3.6 to 4.37	3.60 Titers Interval 3.32 to 3.9

SECONDARY outcome

Timeframe: Day 0 up to Day14 post-vaccination

Population: Solicited injection site and systemic events were assessed in all randomized and vaccinated participants, the Safety Analysis Set.

Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - \>39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - \>3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable.

Outcome measures

Outcome measures
Measure	JE-CV + MMR (Group 1) n=102 Participants Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42	MMR + JE-CV (Group 2) n=196 Participants Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42	JE-CV/MMR (Group 3) n=220 Participants Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Solicited Crying Abnormal (N = 102, 195, 219)	24 Participants	56 Participants Interval 0.0 to 0.0	79 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Grade 3 Crying Abnormal (N = 102, 195, 219)	2 Participants	4 Participants Interval 0.0 to 0.0	5 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Solicited Drowsiness (N = 102, 195, 219)	26 Participants	45 Participants Interval 0.0 to 0.0	67 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Grade 3 Drowsiness (N = 102, 195, 219)	0 Participants	3 Participants Interval 0.0 to 0.0	2 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Solicited Appetite Lost (N = 102, 195, 219)	25 Participants	46 Participants Interval 0.0 to 0.0	78 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Grade 3 Appetite Lost (N = 102, 195, 219)	3 Participants	5 Participants Interval 0.0 to 0.0	6 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Grade 3 Vomiting (N = 102, 195, 219)	0 Participants	3 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Injection site Pain (N = 102, 195, 219)	18 Participants	30 Participants Interval 0.0 to 0.0	35 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Grade 3 Pain (N = 102, 195, 219)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Injection site Erythema (N = 102, 195, 219)	11 Participants	21 Participants Interval 0.0 to 0.0	24 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Grade 3 Erythema (N = 102, 195, 219)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Injection site Swelling (N = 102, 195, 219)	2 Participants	11 Participants Interval 0.0 to 0.0	3 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Grade 3 Swelling (N = 102, 195, 219)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Solicited Fever (N = 102, 195, 219)	17 Participants	35 Participants Interval 0.0 to 0.0	53 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Grade 3 Fever (N = 102, 195, 219)	1 Participants	1 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Solicited Vomiting (N = 102, 195, 219)	15 Participants	21 Participants Interval 0.0 to 0.0	39 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Solicited Irritability (N = 102, 195, 219)	28 Participants	39 Participants Interval 0.0 to 0.0	72 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine Grade 3 Irritability (N = 102, 195, 219)	4 Participants	0 Participants Interval 0.0 to 0.0	2 Participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Day 0 up to Day 14 post-vaccination

Population: Solicited injection site and systemic events were assessed in all randomized and vaccinated participants, the Safety Analysis Set.

Outcome measures

Outcome measures
Measure	JE-CV + MMR (Group 1) n=101 Participants Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42	MMR + JE-CV (Group 2) n=219 Participants Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42	JE-CV/MMR (Group 3) n=220 Participants Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Grade 3 Pain (N = 101, 211, 219)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Grade 3 Appetite Lost (N = 101, 210, 219)	0 Participants	10 Participants Interval 0.0 to 0.0	6 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Solicited Irritability (N = 101, 210, 219)	26 Participants	64 Participants Interval 0.0 to 0.0	72 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Grade 3 Irritability (N = 101, 210, 219)	4 Participants	3 Participants Interval 0.0 to 0.0	2 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Injection site Pain (N = 101, 211, 219)	16 Participants	32 Participants Interval 0.0 to 0.0	36 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Injection site Erythema (N = 101, 211, 219)	7 Participants	22 Participants Interval 0.0 to 0.0	22 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Grade 3 Erythema (N = 101, 211, 219)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Injection site Swelling (N = 101, 211, 219)	3 Participants	7 Participants Interval 0.0 to 0.0	4 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Grade 3 Swelling (N = 101, 211, 219)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Solicited Fever (N = 101, 211, 219)	21 Participants	48 Participants Interval 0.0 to 0.0	53 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Grade 3 Fever (N = 101, 211, 219)	1 Participants	4 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Solicited Vomiting (N = 101, 210, 219)	12 Participants	32 Participants Interval 0.0 to 0.0	39 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Grade 3 Vomiting (N = 101, 210, 219)	0 Participants	2 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Solicited Crying Abnormal (N = 101, 210, 219)	30 Participants	73 Participants Interval 0.0 to 0.0	79 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Grade 3 Crying Abnormal (N = 101, 210, 219)	4 Participants	7 Participants Interval 0.0 to 0.0	5 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Solicited Drowsiness (N = 101, 210, 219)	26 Participants	68 Participants Interval 0.0 to 0.0	67 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Grade 3 Drowsiness (N = 101, 210, 219)	1 Participants	4 Participants Interval 0.0 to 0.0	2 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine Solicited Appetite Lost (N = 101, 210, 219)	29 Participants	80 Participants Interval 0.0 to 0.0	78 Participants Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (pre-vaccination)

Population: Serological status of Flavivirus infection was assessed in the Full Analysis Set.

Neutralizing antibodies levels against dengue were only evaluated on subjects ELISA positive for Immunoglobulin G (IgG) or Immunoglobulin M (IgM). Flavivirus positive was defined as antibodies against JE-CV virus ≥10 (l/dil) or antibodies against at least one dengue virus serotype ≥10 (l/dil); Flavivirus negative was defined as antibodies against JE CV virus \< 10 (l/dil) and antibodies against the 4 dengue virus serotypes \< 10 (l/dil).

Outcome measures

Outcome measures
Measure	JE-CV + MMR (Group 1) n=102 Participants Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42	MMR + JE-CV (Group 2) n=197 Participants Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42	JE-CV/MMR (Group 3) n=221 Participants Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Dengue serotype 2	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine JE-CV virus/dengue serotypes FV Positive	2 Participants	18 Participants Interval 0.0 to 0.0	5 Participants Interval 0.0 to 0.0
Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine JE CV virus/dengue serotypes FV Negative	100 Participants	179 Participants Interval 0.0 to 0.0	216 Participants Interval 0.0 to 0.0
Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine JE CV virus	2 Participants	10 Participants Interval 0.0 to 0.0	4 Participants Interval 0.0 to 0.0
Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Any dengue serotype	0 Participants	8 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0
Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Dengue serotype 1	0 Participants	7 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0
Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Dengue serotype 3	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine Dengue serotype 4	0 Participants	3 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0

Adverse Events

JE CV + MMR (Group 1)

Serious events: 10 serious events

Other events: 30 other events

Deaths: 0 deaths

MMR + JE CV (Group 2)

Serious events: 21 serious events

Other events: 80 other events

Deaths: 0 deaths

JE CV/MMR (Group 3)

Serious events: 13 serious events

Other events: 79 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	JE CV + MMR (Group 1) n=102 participants at risk Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42	MMR + JE CV (Group 2) n=219 participants at risk Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42	JE CV/MMR (Group 3) n=220 participants at risk Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
Nervous system disorders Somnolence	25.5% 26/102 • Number of events 26 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	23.0% 45/196 • Number of events 45 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	30.5% 67/220 • Number of events 67 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Skin and subcutaneous tissue disorders Rash	0.98% 1/102 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	1.0% 2/196 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	5.5% 12/220 • Number of events 12 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
General disorders Injection site Pain	17.6% 18/102 • Number of events 18 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	15.4% 30/195 • Number of events 30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	15.9% 35/220 • Number of events 35 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
General disorders Injection site Erythema	10.8% 11/102 • Number of events 11 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	10.8% 21/195 • Number of events 21 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	10.9% 24/220 • Number of events 24 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
General disorders Injection site Swelling	2.0% 2/102 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	5.6% 11/195 • Number of events 11 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	1.4% 3/220 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
General disorders Fever	20.8% 21/101 • Number of events 21 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	22.7% 48/211 • Number of events 48 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	24.1% 53/220 • Number of events 53 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Gastrointestinal disorders Vomiting	11.9% 12/101 • Number of events 12 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	15.2% 32/210 • Number of events 32 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	17.7% 39/220 • Number of events 39 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Psychiatric disorders Crying Abnormal	29.7% 30/101 • Number of events 30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	34.8% 73/210 • Number of events 73 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	35.9% 79/220 • Number of events 79 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Nervous system disorders Drowsiness	25.7% 26/101 • Number of events 26 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	32.4% 68/210 • Number of events 68 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	30.5% 67/220 • Number of events 67 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Metabolism and nutrition disorders Appetite Lost	28.7% 29/101 • Number of events 29 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	38.1% 80/210 • Number of events 80 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	35.5% 78/220 • Number of events 78 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Psychiatric disorders Irritability	25.7% 26/101 • Number of events 26 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	30.5% 64/210 • Number of events 64 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	32.7% 72/220 • Number of events 72 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
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