Trial Outcomes & Findings for Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children (NCT NCT00621764)

Last Updated: 2014-10-02

Results Overview

12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, \>39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, \>3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, \>39˚C; Headache, Malaise, and Myalgia, Prevents activities.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

300 participants

Primary outcome timeframe

Day 0 up to Day 14 post-vaccination

Results posted on

2014-10-02

Participant Flow

The study participants were enrolled from 02 March 2008 to 06 January 2009 at 3 clinic centers in Thailand.

A total of 300 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.

Participant milestones

Participant milestones
Measure	JE-CV/Hepatitis A (Group 1) Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE-CV (Group 2) Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart	JE-CV/Hepatitis A (Group 3) Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE-CV (Group 4) Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Overall Study STARTED	50	50	101	99
Overall Study COMPLETED	50	50	101	98
Overall Study NOT COMPLETED	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	JE-CV/Hepatitis A (Group 1) Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE-CV (Group 2) Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart	JE-CV/Hepatitis A (Group 3) Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE-CV (Group 4) Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Overall Study Protocol Violation	0	0	0	1

Baseline Characteristics

Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	JE CV/Hepatitis A (Group 1) n=50 Participants Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE CV (Group 2) n=50 Participants Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart	JE CV/Hepatitis A (Group 3) n=101 Participants Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE CV (Group 4) n=99 Participants Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart	Total n=300 Participants Total of all reporting groups
Age, Categorical <=18 years	50 Participants n=5 Participants	50 Participants n=7 Participants	101 Participants n=5 Participants	99 Participants n=4 Participants	300 Participants n=21 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	0 Participants n=21 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	0 Participants n=21 Participants
Age, Continuous	2.4 Years STANDARD_DEVIATION 0.5 • n=5 Participants	2.5 Years STANDARD_DEVIATION 0.6 • n=7 Participants	1.4 Years STANDARD_DEVIATION 0.2 • n=5 Participants	1.3 Years STANDARD_DEVIATION 0.2 • n=4 Participants	1.7 Years STANDARD_DEVIATION 0.6 • n=21 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	35 Participants n=7 Participants	57 Participants n=5 Participants	57 Participants n=4 Participants	166 Participants n=21 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	15 Participants n=7 Participants	44 Participants n=5 Participants	42 Participants n=4 Participants	134 Participants n=21 Participants
Region of Enrollment Thailand	50 Participants n=5 Participants	50 Participants n=7 Participants	101 Participants n=5 Participants	99 Participants n=4 Participants	300 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 0 up to Day 14 post-vaccination

Population: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.

Outcome measures

PRIMARY outcome

Timeframe: Day 0 up to Day 14 post-vaccination

Population: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine. A participant in Group 1 was given JE-CV vaccine as the second vaccination in error; and counted for Group 2 for the safety outcome for the second injection.

Outcome measures

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 28 after final vaccination

Population: Seroconversion to the JE-CV vaccine antigens was assessed in the Per-Protocol Analysis Set.

JE virus neutralizing antibody measurement was assessed by plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer \< 10 (1/dil) and post-vaccination titer ≥ 10 (1/dil), or participants with pre-vaccination titer ≥ 10 (1/dil) and 4-fold increase from pre- to post-vaccination.

Outcome measures

Outcome measures
Measure	JE-CV/Hepatitis A (Group 1) n=49 Participants Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE-CV (Group 2) n=48 Participants Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart	JE-CV/Hepatitis A (Group 3) n=87 Participants Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE-CV (Group 4) n=95 Participants Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination Homologous virus (N=49,48,83,88)	89.8 Percentage of participants	95.8 Percentage of participants Interval 0.0 to 0.0	100.0 Percentage of participants Interval 0.0 to 0.0	93.2 Percentage of participants Interval 0.0 to 0.0
Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination Genotype I (N=49,48,81,91)	83.7 Percentage of participants	93.8 Percentage of participants Interval 0.0 to 0.0	98.8 Percentage of participants Interval 0.0 to 0.0	95.6 Percentage of participants Interval 0.0 to 0.0
Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination Genotype II (N=49,48,81,91)	83.7 Percentage of participants	93.8 Percentage of participants Interval 0.0 to 0.0	96.3 Percentage of participants Interval 0.0 to 0.0	95.6 Percentage of participants Interval 0.0 to 0.0
Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination Genotype III (N=49,48,81,93)	87.8 Percentage of participants	91.7 Percentage of participants Interval 0.0 to 0.0	100.0 Percentage of participants Interval 0.0 to 0.0	94.6 Percentage of participants Interval 0.0 to 0.0
Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination Genotype IV (N=49,48,81,90)	89.8 Percentage of participants	91.7 Percentage of participants Interval 0.0 to 0.0	74.1 Percentage of participants Interval 0.0 to 0.0	65.6 Percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 28 after final vaccination

Population: Geometric mean titers against the JE-CV vaccine antigens were assessed in the Per-Protocol Analysis Set.

JE virus neutralizing antibody measurement was assessed by the PRNT50 assay.

Outcome measures

Outcome measures
Measure	JE-CV/Hepatitis A (Group 1) n=49 Participants Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE-CV (Group 2) n=48 Participants Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart	JE-CV/Hepatitis A (Group 3) n=87 Participants Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE-CV (Group 4) n=95 Participants Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination Homologous virus (pre-vaccination; N=49,48,86,90)	49.5 Titers Interval 33.9 to 72.1	40.6 Titers Interval 26.4 to 62.4	5.78 Titers Interval 5.25 to 6.37	5.08 Titers Interval 4.92 to 5.24
Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination Homologous virus (post-vaccination; N=49,48,84,93)	1957 Titers Interval 1227.0 to 3120.0	3568 Titers Interval 2361.0 to 5394.0	500 Titers Interval 353.0 to 708.0	167 Titers Interval 120.0 to 233.0
Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination Genotype I (pre-vaccination; N=49,48,83,91)	55.2 Titers Interval 36.0 to 84.6	55.3 Titers Interval 35.3 to 86.7	5.00 Titers Interval 5.0 to 5.0	5.00 Titers Interval 5.0 to 5.0
Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination Genotype I (post-vaccination; N=49,48,82,94)	1016 Titers Interval 703.0 to 1467.0	1988 Titers Interval 1427.0 to 2770.0	170 Titers Interval 130.0 to 223.0	155 Titers Interval 117.0 to 206.0
Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination Genotype II (pre-vaccination; N=49,48,83,91)	46.5 Titers Interval 31.9 to 67.9	34.2 Titers Interval 22.7 to 51.4	5.00 Titers Interval 5.0 to 5.0	5.00 Titers Interval 5.0 to 5.0
Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination Genotype II (post-vaccination; N=49,48,82,94)	921 Titers Interval 625.0 to 1356.0	1566 Titers Interval 1090.0 to 2250.0	157 Titers Interval 119.0 to 206.0	121 Titers Interval 93.7 to 156.0
Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination Genotype III (pre-vaccination; N=49,48,83,93)	39.2 Titers Interval 27.0 to 57.0	40.6 Titers Interval 25.7 to 64.0	5.00 Titers Interval 5.0 to 5.0	5.00 Titers Interval 5.0 to 5.0
Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination Genotype III (post-vaccination; N=49,48,82,94)	1107 Titers Interval 726.0 to 1689.0	2089 Titers Interval 1405.0 to 3105.0	189 Titers Interval 140.0 to 255.0	98.2 Titers Interval 73.2 to 132.0
Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination Genotype IV (pre-vaccination; N=49,48,83,90)	25.2 Titers Interval 18.1 to 35.1	20.0 Titers Interval 13.8 to 28.9	5.00 Titers Interval 5.0 to 5.0	5.00 Titers Interval 5.0 to 5.0
Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination Genotype IV (post-vaccination; N=49,48,82,94)	604 Titers Interval 387.0 to 944.0	829 Titers Interval 575.0 to 1195.0	25.3 Titers Interval 19.1 to 33.5	17.0 Titers Interval 13.6 to 21.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (pre-vaccination) up to 5 years after final vaccination

Population: Persistence of seroprotection to JE-CV antigens was assessed in the Full Analysis Set.

Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.

Outcome measures

Outcome measures
Measure	JE-CV/Hepatitis A (Group 1) n=50 Participants Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE-CV (Group 2) n=50 Participants Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart	JE-CV/Hepatitis A (Group 3) n=101 Participants Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE-CV (Group 4) n=99 Participants Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Homologous virus (pre-vaccination; N=50,50,100,94)	45 Participants	41 Participants Interval 0.0 to 0.0	15 Participants Interval 0.0 to 0.0	2 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Homologous virus (post-vaccination; N=49,50,98,96)	49 Participants	50 Participants Interval 0.0 to 0.0	98 Participants Interval 0.0 to 0.0	89 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Homologous virus (post-6 months; N=48,49,99,98)	48 Participants	49 Participants Interval 0.0 to 0.0	91 Participants Interval 0.0 to 0.0	80 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Homologous virus (post-1 year; N=48,45,91,89)	46 Participants	44 Participants Interval 0.0 to 0.0	81 Participants Interval 0.0 to 0.0	71 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Homologous virus (post-2 years; N=43,41,85,79)	41 Participants	41 Participants Interval 0.0 to 0.0	74 Participants Interval 0.0 to 0.0	64 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Homologous virus (post-3 years; N=40,38,68,56)	40 Participants	38 Participants Interval 0.0 to 0.0	66 Participants Interval 0.0 to 0.0	52 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Homologous virus (post-4 years; N=41,36,63,56)	41 Participants	36 Participants Interval 0.0 to 0.0	63 Participants Interval 0.0 to 0.0	54 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Homologous virus (post-5 years; N=40,38,60,50)	40 Participants	38 Participants Interval 0.0 to 0.0	55 Participants Interval 0.0 to 0.0	44 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Genotype I (pre-vaccination; N=50,50,97,95)	40 Participants	41 Participants Interval 0.0 to 0.0	8 Participants Interval 0.0 to 0.0	3 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Genotype I (post-vaccination; N=49,50,96,97)	49 Participants	50 Participants Interval 0.0 to 0.0	95 Participants Interval 0.0 to 0.0	93 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Genotype I (post-6 months; N=47,48,99,98)	47 Participants	48 Participants Interval 0.0 to 0.0	95 Participants Interval 0.0 to 0.0	86 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Genotype II (pre-vaccination; N=49,50,97,95)	39 Participants	39 Participants Interval 0.0 to 0.0	9 Participants Interval 0.0 to 0.0	2 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Genotype II (post-vaccination; N=49,50,96,97)	49 Participants	50 Participants Interval 0.0 to 0.0	93 Participants Interval 0.0 to 0.0	93 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Genotype II (post-6 months; N=47,48,99,98)	47 Participants	48 Participants Interval 0.0 to 0.0	90 Participants Interval 0.0 to 0.0	80 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Genotype III (pre-vaccination; N=50,50,97,97)	41 Participants	38 Participants Interval 0.0 to 0.0	5 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Genotype III (post-vaccination; N=49,50,96,97)	49 Participants	50 Participants Interval 0.0 to 0.0	96 Participants Interval 0.0 to 0.0	92 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Genotype III (post-6 months; N=48,48,99,98)	48 Participants	48 Participants Interval 0.0 to 0.0	73 Participants Interval 0.0 to 0.0	62 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Genotype IV (pre-vaccination; N=49,50,97,94)	39 Participants	32 Participants Interval 0.0 to 0.0	5 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Genotype IV (post-vaccination; N=49,50,96,97)	48 Participants	50 Participants Interval 0.0 to 0.0	73 Participants Interval 0.0 to 0.0	65 Participants Interval 0.0 to 0.0
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination Genotype IV (post-6 months; N=47,48,99,98)	47 Participants	48 Participants Interval 0.0 to 0.0	68 Participants Interval 0.0 to 0.0	46 Participants Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (pre-vaccination) up to 5 years after final vaccination

Population: Geometric Mean Titers Against JE Antibodies were assessed in the Full Analysis Set.

Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.

Outcome measures

Outcome measures
Measure	JE-CV/Hepatitis A (Group 1) n=50 Participants Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE-CV (Group 2) n=50 Participants Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart	JE-CV/Hepatitis A (Group 3) n=101 Participants Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE-CV (Group 4) n=99 Participants Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Homologous virus (pre-vaccination; N=50,50,100,94)	48.6 Titers Interval 33.5 to 70.4	41.1 Titers Interval 27.2 to 62.2	6.11 Titers Interval 5.51 to 6.78	5.15 Titers Interval 4.94 to 5.37
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Homologous virus (post-vaccination; N=49,50,98,96)	1956.7 Titers Interval 1227.1 to 3120.0	3722.2 Titers Interval 2489.2 to 5565.9	517.6 Titers Interval 371.7 to 720.9	167.1 Titers Interval 120.2 to 232.2
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Homologous virus (post-6 months; N=48,49,99,98)	892.1 Titers Interval 566.1 to 1405.8	1244.3 Titers Interval 798.8 to 1938.3	96.6 Titers Interval 71.4 to 130.9	49.8 Titers Interval 36.8 to 67.4
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Homologous virus (post-1 year; N=48,45,91,89)	339 Titers Interval 216.0 to 531.0	621 Titers Interval 382.0 to 1009.0	78.8 Titers Interval 57.8 to 107.0	49.0 Titers Interval 34.9 to 68.6
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Homologous virus (post-2 years; N=43,41,85,79)	414 Titers Interval 246.0 to 698.0	662 Titers Interval 403.0 to 1088.0	94.2 Titers Interval 66.0 to 134.0	67.1 Titers Interval 46.3 to 97.3
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Homologous virus (post-3 years; N=40,38,68,56)	422 Titers Interval 273.0 to 654.0	505 Titers Interval 339.0 to 751.0	146 Titers Interval 102.0 to 208.0	90.5 Titers Interval 62.6 to 131.0
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Homologous virus (post-4 years; N=41,36,63,56)	360 Titers Interval 223.0 to 582.0	559 Titers Interval 306.0 to 1023.0	137 Titers Interval 100.0 to 188.0	110 Titers Interval 77.5 to 157.0
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Homologous virus (post-5 years; N=40,38,60,50)	222 Titers Interval 151.0 to 328.0	287 Titers Interval 183.0 to 449.0	68.8 Titers Interval 48.3 to 98.1	58.2 Titers Interval 36.4 to 93.0
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Genotype I (pre-vaccination; N=50,50,97,95)	54.8 Titers Interval 36.1 to 83.3	55.3 Titers Interval 35.2 to 86.9	5.62 Titers Interval 5.18 to 6.11	5.18 Titers Interval 4.96 to 5.41
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Genotype I (post-vaccination; N=49,50,96,97)	1015.8 Titers Interval 703.4 to 1466.9	2116.7 Titers Interval 1519.8 to 2948.1	186.8 Titers Interval 142.2 to 245.3	163.1 Titers Interval 122.5 to 217.1
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Genotype I (6-months; N=47,48,99,98)	863.5 Titers Interval 573.9 to 1299.3	981.0 Titers Interval 678.4 to 1418.4	81.4 Titers Interval 62.8 to 105.5	52.4 Titers Interval 40.2 to 68.2
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Genotype II (pre-vaccination; N=49,50,97,95)	46.5 Titers Interval 31.9 to 67.9	33.3 Titers Interval 22.3 to 49.6	5.75 Titers Interval 5.16 to 6.4	5.20 Titers Interval 4.9 to 5.53
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Genotype II (post-vaccination; N=49,50,96,97)	920.6 Titers Interval 624.9 to 1356.2	1763.4 Titers Interval 1199.3 to 2592.9	163.2 Titers Interval 125.5 to 212.3	126.8 Titers Interval 97.8 to 164.4
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Genotype II (post-6 months; N=47,48,99,98)	581.2 Titers Interval 402.9 to 838.3	714.4 Titers Interval 520.4 to 980.7	72.3 Titers Interval 54.4 to 96.1	42.4 Titers Interval 31.7 to 56.8
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Genotype III (pre-vaccination; N=50,50,97,97)	37.6 Titers Interval 25.8 to 54.7	41.1 Titers Interval 26.5 to 63.7	5.39 Titers Interval 5.04 to 5.76	5.08 Titers Interval 4.93 to 5.23
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Genotype III (post-vaccination; N=49,50,96,97)	1107.1 Titers Interval 725.8 to 1688.7	2210.4 Titers Interval 1498.2 to 3261.0	200.2 Titers Interval 151.5 to 264.6	102.1 Titers Interval 75.8 to 137.6
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Genotype III (post-6 months; N=48,48,99,98)	513.1 Titers Interval 326.5 to 806.5	645.7 Titers Interval 438.7 to 950.4	31.1 Titers Interval 23.3 to 41.5	20.2 Titers Interval 15.6 to 26.3
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Genotype IV (pre-vaccination; N=49,50,97,94)	25.2 Titers Interval 18.1 to 35.1	19.7 Titers Interval 13.8 to 28.2	5.31 Titers Interval 5.03 to 5.6	5.00 Titers Interval 5.0 to 5.0
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Genotype IV (post-vaccination; N=49,50,96,97)	604.0 Titers Interval 386.6 to 943.6	874.0 Titers Interval 610.0 to 1252.3	28.5 Titers Interval 21.5 to 37.7	18.1 Titers Interval 14.3 to 23.0
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine Genotype IV (post-6 months; N=47,48,99,98)	279.4 Titers Interval 194.1 to 402.3	363.4 Titers Interval 256.8 to 514.3	21.0 Titers Interval 16.2 to 27.2	12.6 Titers Interval 9.93 to 16.0

Adverse Events

JE CV/Hepatitis A (Group 1)

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Hepatitis A/JE CV (Group 2)

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

JE CV/Hepatitis A (Group 3)

Serious events: 11 serious events

Other events: 43 other events

Deaths: 0 deaths

Hepatitis A/JE CV (Group 4)

Serious events: 10 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	JE CV/Hepatitis A (Group 1) n=50 participants at risk Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE CV (Group 2) n=50 participants at risk Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart	JE CV/Hepatitis A (Group 3) n=101 participants at risk Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE CV (Group 4) n=99 participants at risk Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
Infections and infestations Bronchiolitis	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/101 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	2.0% 2/99 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Bronchitis	2.0% 1/50 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.99% 1/101 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/99 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Gastroenteritis	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	2.0% 1/50 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	4.0% 4/101 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/99 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Gastroenteritis rotavirus	2.0% 1/50 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/101 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	1.0% 1/99 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Herpangina	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/101 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	1.0% 1/99 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Influenza	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/101 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	1.0% 1/99 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Pharyngitis	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.99% 1/101 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	1.0% 1/99 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Pneumonia	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	2.0% 1/50 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	2.0% 2/101 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	1.0% 1/99 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Pneumonia viral	2.0% 1/50 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.99% 1/101 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	1.0% 1/99 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Upper respiratory tract infection	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.99% 1/101 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/99 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Viral infection	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.99% 1/101 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/99 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Injury, poisoning and procedural complications Wound	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	2.0% 1/50 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.99% 1/101 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/99 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Nervous system disorders Febrile convulsion	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	2.0% 1/50 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.99% 1/101 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	3.0% 3/99 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.

Other adverse events

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.
Publication restrictions are in place

Restriction type: OTHER

Measure	JE-CV/Hepatitis A (Group 1) n=50 Participants Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE-CV (Group 2) n=50 Participants Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart	JE-CV/Hepatitis A (Group 3) n=101 Participants Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE-CV (Group 4) n=99 Participants Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Malaise (N=50,50,0,0)	15 Participants	13 Participants Interval 0.0 to 0.0	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Injection site Pain (N=50,50,0,0)	15 Participants	13 Participants Interval 0.0 to 0.0	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Grade 3 Injection site Pain (N=50,50,0,0)	0 Participants	0 Participants Interval 0.0 to 0.0	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Injection site Tenderness (N=0,0,101,99)	NA Participants This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	43 Participants Interval 0.0 to 0.0	19 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Grade 3 Injection site Tenderness (N=0,0,101,99)	NA Participants This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Injection site Erythema (N=50,50,101,99)	7 Participants	9 Participants Interval 0.0 to 0.0	23 Participants Interval 0.0 to 0.0	16 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Grade 3 Injection site Erythema (N=50,50,101,99)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Injection site Swelling (N=50,50,101,99)	4 Participants	5 Participants Interval 0.0 to 0.0	6 Participants Interval 0.0 to 0.0	8 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Grade 3 Swelling (N=50,50,101,99)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Fever (N=50,50,101,99)	8 Participants	8 Participants Interval 0.0 to 0.0	14 Participants Interval 0.0 to 0.0	18 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Grade 3 Fever (N=50,50,101,99)	1 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Headache (N=50,50,0,0)	7 Participants	7 Participants Interval 0.0 to 0.0	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Grade 3 Headache (N=50,50,0,0)	0 Participants	0 Participants Interval 0.0 to 0.0	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Grade 3 Malaise (N=50,50,0,0)	0 Participants	0 Participants Interval 0.0 to 0.0	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Myalgia (N=50,50,0,0)	14 Participants	8 Participants Interval 0.0 to 0.0	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Grade 3 Myalgia (N=50,50,0,0)	0 Participants	0 Participants Interval 0.0 to 0.0	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Vomiting (N=0,0,101,99)	NA Participants This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	21 Participants Interval 0.0 to 0.0	21 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Grade 3 Vomiting (N=0,0,101,99)	NA Participants This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	1 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Crying abnormal (N=0,0,101,99)	NA Participants This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	24 Participants Interval 0.0 to 0.0	20 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Grade 3 Crying abnormal (N=0,0,101,99)	NA Participants This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Drowsiness (N=0,0,101,99)	NA Participants This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	22 Participants Interval 0.0 to 0.0	13 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Grade 3 Drowsiness (N=0,0,101,99)	NA Participants This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Appetite lost (N=0,0,101,99)	NA Participants This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	28 Participants Interval 0.0 to 0.0	32 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Grade 3 Appetite lost (N=0,0,101,99)	NA Participants This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	0 Participants Interval 0.0 to 0.0	2 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Irritability (N=0,0,101,99)	NA Participants This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	32 Participants Interval 0.0 to 0.0	24 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection Grade 3 Irritability (N=0,0,101,99)	NA Participants This safety event was not solicited for this group	NA Participants Interval 0.0 to 0.0 This safety event was not solicited for this group	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0

Measure	JE CV/Hepatitis A (Group 1) n=50 participants at risk Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE CV (Group 2) n=50 participants at risk Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart	JE CV/Hepatitis A (Group 3) n=101 participants at risk Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart	Hepatitis A/JE CV (Group 4) n=99 participants at risk Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
General disorders Pyrexia	6.0% 3/50 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/101 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/99 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Bronchitis	6.2% 3/48 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	6.0% 3/50 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/101 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/99 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Nasopharyngitis	2.0% 1/50 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	10.0% 5/50 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	5.0% 5/101 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	11.1% 11/99 • Number of events 12 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Upper respiratory tract infection	16.0% 8/50 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	16.0% 8/50 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	34.7% 35/101 • Number of events 35 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	35.4% 35/99 • Number of events 39 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Respiratory, thoracic and mediastinal disorders Cough	8.0% 4/50 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	2.0% 1/50 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/101 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/99 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.0% 3/50 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	2.0% 1/50 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	12.9% 13/101 • Number of events 16 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	11.1% 11/99 • Number of events 12 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Skin and subcutaneous tissue disorders Heat rash	6.2% 3/48 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/101 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/99 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
General disorders Injection-site pain	31.2% 15/48 • Number of events 15 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	26.0% 13/50 • Number of events 13 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
General disorders Injection-site tenderness	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	42.6% 43/101 • Number of events 43 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	20.4% 20/98 • Number of events 20 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
General disorders Injection-site erythema	16.7% 8/48 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	18.0% 9/50 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	23.0% 23/100 • Number of events 23 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	22.4% 22/98 • Number of events 22 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
General disorders Injection-site swelling	16.7% 8/48 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	10.0% 5/50 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	6.0% 6/100 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	11.2% 11/98 • Number of events 11 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
General disorders Fever	16.0% 8/50 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	28.0% 14/50 • Number of events 14 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	23.0% 23/100 • Number of events 23 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	28.6% 28/98 • Number of events 28 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Nervous system disorders Headache	14.6% 7/48 • Number of events 7 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	28.0% 14/50 • Number of events 14 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
General disorders Malaise	30.0% 15/50 • Number of events 15 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	36.0% 18/50 • Number of events 18 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Musculoskeletal and connective tissue disorders Myalgia	28.0% 14/50 • Number of events 14 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	20.0% 10/50 • Number of events 10 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Gastrointestinal disorders Vomiting	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	23.0% 23/100 • Number of events 23 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	21.2% 21/99 • Number of events 21 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Psychiatric disorders Crying abnormal	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	23.8% 24/101 • Number of events 24 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	21.4% 21/98 • Number of events 21 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Nervous system disorders Drowsiness	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	21.8% 22/101 • Number of events 22 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	14.3% 14/98 • Number of events 14 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Metabolism and nutrition disorders Appetite lost	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	27.7% 28/101 • Number of events 28 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	32.3% 32/99 • Number of events 32 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Psychiatric disorders Irritability	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	31.7% 32/101 • Number of events 32 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	24.5% 24/98 • Number of events 24 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.