Trial Outcomes & Findings for Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines (NCT NCT00735644)

NCT ID: NCT00735644

Last Updated: 2015-04-21

Results Overview

Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% 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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1200 participants
• Primary outcome timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccination
• Results posted on: 2015-04-21

Participant Flow

The study participants were enrolled from 02 August 2008 through 27 March 2009 at 3 clinic sites in Thailand and 5 clinic sites in the Philippines.

A total of 1200 participants who met all of the inclusion and none of the exclusion criteria were randomized, 1199 were vaccinated in this study.

Participant milestones

Measure	JE-CV GPO MBP (Lot 1) Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1.	JE-CV GPO MBP (Lot 2) Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	JE-CV GPO MBP (Lot 3) Participants 12 to 18 months of age received one dose of JE- CV from GPO MBP Lot 3	JE-CV WRAIR Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Hepatitis A Participants 12 to 18 months of age received the Hepatitis A vaccine
Overall Study STARTED	303	300	296	199	102
Overall Study COMPLETED	303	298	295	198	102
Overall Study NOT COMPLETED	0	2	1	1	0

Reasons for withdrawal

Measure	JE-CV GPO MBP (Lot 1) Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1.	JE-CV GPO MBP (Lot 2) Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	JE-CV GPO MBP (Lot 3) Participants 12 to 18 months of age received one dose of JE- CV from GPO MBP Lot 3	JE-CV WRAIR Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Hepatitis A Participants 12 to 18 months of age received the Hepatitis A vaccine
Overall Study Did not receive study vaccine	0	1	0	0	0
Overall Study Withdrawal by Subject	0	1	1	1	0

Baseline Characteristics

Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

Baseline characteristics by cohort

Measure	JE CV GPO MBP (Lot 1) n=303 Participants Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously	JE-CV GPO MBP (Lot 2) n=299 Participants Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	JE-CV GPO MBP (Lot 3) n=296 Participants Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3	JE-CV WRAIR n=199 Participants Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Hepatitis A n=102 Participants Participants 12 to 18 months of age received Hepatitis A vaccine	Total n=1199 Participants Total of all reporting groups
Age, Categorical <=18 years	303 Participants n=5 Participants	299 Participants n=7 Participants	296 Participants n=5 Participants	199 Participants n=4 Participants	102 Participants n=21 Participants	1199 Participants n=8 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	0 Participants n=8 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	0 Participants n=8 Participants
Age, Continuous	14.3 Months STANDARD_DEVIATION 1.91 • n=5 Participants	14.5 Months STANDARD_DEVIATION 1.84 • n=7 Participants	14.4 Months STANDARD_DEVIATION 1.88 • n=5 Participants	14.3 Months STANDARD_DEVIATION 1.81 • n=4 Participants	14.3 Months STANDARD_DEVIATION 1.93 • n=21 Participants	14.4 Months STANDARD_DEVIATION 1.87 • n=8 Participants
Sex: Female, Male Female	155 Participants n=5 Participants	138 Participants n=7 Participants	143 Participants n=5 Participants	94 Participants n=4 Participants	45 Participants n=21 Participants	575 Participants n=8 Participants
Sex: Female, Male Male	148 Participants n=5 Participants	161 Participants n=7 Participants	153 Participants n=5 Participants	105 Participants n=4 Participants	57 Participants n=21 Participants	624 Participants n=8 Participants
Region of Enrollment Thailand	123 Participants n=5 Participants	122 Participants n=7 Participants	121 Participants n=5 Participants	82 Participants n=4 Participants	42 Participants n=21 Participants	490 Participants n=8 Participants
Region of Enrollment Philippines	180 Participants n=5 Participants	177 Participants n=7 Participants	175 Participants n=5 Participants	117 Participants n=4 Participants	60 Participants n=21 Participants	709 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccination

Population: Seroconversion to the JE CV vaccine antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.

Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% 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

Measure	JE CV GPO MBP (Lot 1) n=288 Participants Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously	JE-CV GPO MBP (Lot 2) n=292 Participants Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	JE-CV GPO MBP (Lot 3) n=286 Participants Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3	JE-CV WRAIR n=193 Participants Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Hepatitis A n=97 Participants Participants 12 to 18 months of age received Hepatitis A vaccine
Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots JE CV Day 0 (≥10 1/dil; N=288, 290, 285, 192, 0)	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	NA Participants Interval 0.0 to 0.0 Anti-Japanese encephalitis chimeric virus vaccine antibodies were not assayed in this group
Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots JE CV Day 28 (≥10 1/dil; N=288, 284, 283, 192, 0)	282 Participants	262 Participants Interval 0.0 to 0.0	267 Participants Interval 0.0 to 0.0	185 Participants Interval 0.0 to 0.0	NA Participants Interval 0.0 to 0.0 Anti-Japanese encephalitis chimeric virus vaccine antibodies were not assayed in this group

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccination

Population: Geometric mean titers against the JE CV antigens were assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.

Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay.

Outcome measures

Measure	JE CV GPO MBP (Lot 1) n=288 Participants Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously	JE-CV GPO MBP (Lot 2) n=292 Participants Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	JE-CV GPO MBP (Lot 3) n=286 Participants Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3	JE-CV WRAIR n=193 Participants Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Hepatitis A Participants 12 to 18 months of age received Hepatitis A vaccine
Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV Anti JE-CV Day 0 (N=288, 290, 285, 192, 0)	5.17 Titers Interval 5.06 to 5.29	5.08 Titers Interval 4.99 to 5.17	5.19 Titers Interval 5.02 to 5.37	5.09 Titers Interval 4.95 to 5.24	—
Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV Anti JE CV Day 28 (N=288, 284, 283, 192, 0)	212 Titers Interval 179.0 to 252.0	167 Titers Interval 138.0 to 202.0	188 Titers Interval 156.0 to 226.0	212 Titers Interval 168.0 to 268.0	—

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccination

Population: Seroprotection against JE CV antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.

Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the PRNT50 assay. Seroprotection was defined as the proportion of subjects with a JE CV virus PRNT50 neutralizing antibody titer ≥10 1/dilution (dil).

Outcome measures

Measure	JE CV GPO MBP (Lot 1) n=288 Participants Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously	JE-CV GPO MBP (Lot 2) n=292 Participants Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	JE-CV GPO MBP (Lot 3) n=286 Participants Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3	JE-CV WRAIR n=193 Participants Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Hepatitis A n=97 Participants Participants 12 to 18 months of age received Hepatitis A vaccine
Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV JE CV Day 0 (N=288, 290, 285, 192, 0)	10 Participants	4 Participants Interval 0.0 to 0.0	8 Participants Interval 0.0 to 0.0	2 Participants Interval 0.0 to 0.0	NA Participants Interval 0.0 to 0.0 Japanese encephalitis chimeric virus vaccine antibodies were not measured in this group
Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV JE CV Day 28 (N=288, 284, 283, 192, 0)	297 Participants	269 Participants Interval 0.0 to 0.0	276 Participants Interval 0.0 to 0.0	190 Participants Interval 0.0 to 0.0	NA Participants Interval 0.0 to 0.0 Japanese encephalitis chimeric virus vaccine antibodies were not measured in this group

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccination

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

Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay.

Outcome measures

Measure	JE CV GPO MBP (Lot 1) n=288 Participants Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously	JE-CV GPO MBP (Lot 2) n=292 Participants Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	JE-CV GPO MBP (Lot 3) n=286 Participants Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3	JE-CV WRAIR n=193 Participants Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Hepatitis A n=97 Participants Participants 12 to 18 months of age received Hepatitis A vaccine
Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine	41.1 Titer ratio Interval 34.6 to 48.7	32.9 Titer ratio Interval 27.3 to 39.8	36.6 Titer ratio Interval 30.3 to 44.1	42.2 Titer ratio Interval 33.3 to 53.3	NA Titer ratio Participants in this group did not receive a Japanese encephalitis chimeric virus vaccine

SECONDARY outcome

Timeframe: Day 0 up to Day 14 post-vaccination

Population: Solicited injection site and systemic reactions were assessed in the Safety Analysis Set. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.

Solicited injection site: Tenderness, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Tenderness, cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling ≥5 cm. Grade 3 systemic reactions: Fever, temperature >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 up; Appetite Lost, refuses ≥3 or most feeds/meals; and Irritability, inconsolable.

Outcome measures

Measure	JE CV GPO MBP (Lot 1) n=302 Participants Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously	JE-CV GPO MBP (Lot 2) n=299 Participants Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	JE-CV GPO MBP (Lot 3) n=297 Participants Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3	JE-CV WRAIR n=199 Participants Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Hepatitis A n=102 Participants Participants 12 to 18 months of age received Hepatitis A vaccine
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Injection site Tenderness	58 Participants	59 Participants Interval 0.0 to 0.0	67 Participants Interval 0.0 to 0.0	59 Participants Interval 0.0 to 0.0	18 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Grade 3 Injection site Tenderness	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	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Injection site Erythema	64 Participants	63 Participants Interval 0.0 to 0.0	87 Participants Interval 0.0 to 0.0	54 Participants Interval 0.0 to 0.0	26 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Grade 3 Injection site Erythema	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	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Injection site Swelling	22 Participants	20 Participants Interval 0.0 to 0.0	21 Participants Interval 0.0 to 0.0	13 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 Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Grade 3 Injection site Swelling	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	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Fever	51 Participants	62 Participants Interval 0.0 to 0.0	64 Participants Interval 0.0 to 0.0	48 Participants Interval 0.0 to 0.0	21 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Vomiting	60 Participants	57 Participants Interval 0.0 to 0.0	53 Participants Interval 0.0 to 0.0	39 Participants Interval 0.0 to 0.0	16 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Grade 3 Crying Abnormal	1 Participants	0 Participants Interval 0.0 to 0.0	1 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 Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Drowsiness	58 Participants	53 Participants Interval 0.0 to 0.0	53 Participants Interval 0.0 to 0.0	38 Participants Interval 0.0 to 0.0	20 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Grade 3 Drowsiness	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	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Appetite Lost	82 Participants	71 Participants Interval 0.0 to 0.0	74 Participants Interval 0.0 to 0.0	57 Participants Interval 0.0 to 0.0	27 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Grade 3 Appetite Lost	3 Participants	1 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0	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 Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Irritability	91 Participants	79 Participants Interval 0.0 to 0.0	79 Participants Interval 0.0 to 0.0	65 Participants Interval 0.0 to 0.0	28 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Grade 3 Irritability	2 Participants	0 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0	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 Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Grade 3 Fever	3 Participants	5 Participants Interval 0.0 to 0.0	3 Participants Interval 0.0 to 0.0	1 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 Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Grade 3 Vomiting	3 Participants	1 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0	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 Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. Crying Abnormal	58 Participants	54 Participants Interval 0.0 to 0.0	50 Participants Interval 0.0 to 0.0	41 Participants Interval 0.0 to 0.0	21 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 Per-protocol Analysis Set.

Flavivirus (FV) positive was defined as anti-JE against homologous virus strain ≥10 l/dil or anti dengue against at least one serotype ≥10 l/dil. FV negative was defined as anti-JE against homologous virus strain <10 l/dil and anti-dengue against the 4 serotypes <10 l/dilution.

Outcome measures

Measure	JE CV GPO MBP (Lot 1) n=288 Participants Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously	JE-CV GPO MBP (Lot 2) n=292 Participants Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	JE-CV GPO MBP (Lot 3) n=285 Participants Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3	JE-CV WRAIR n=192 Participants Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Hepatitis A n=97 Participants Participants 12 to 18 months of age received Hepatitis A vaccine
Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. JE CV/dengue FV positive (N=288,290,285,192,97)	19 Participants	23 Participants Interval 0.0 to 0.0	32 Participants Interval 0.0 to 0.0	15 Participants Interval 0.0 to 0.0	13 Participants Interval 0.0 to 0.0
Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. JE CV/dengue FV negative (N=288,290,285,192,97)	265 Participants	266 Participants Interval 0.0 to 0.0	249 Participants Interval 0.0 to 0.0	176 Participants Interval 0.0 to 0.0	84 Participants Interval 0.0 to 0.0
Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. JE CV (N=288, 290, 285, 192, 97)	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	0 Participants Interval 0.0 to 0.0
Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. Dengue serotype 1 (N=284, 289, 282, 192, 97)	17 Participants	19 Participants Interval 0.0 to 0.0	28 Participants Interval 0.0 to 0.0	14 Participants Interval 0.0 to 0.0	13 Participants Interval 0.0 to 0.0
Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. Dengue serotype 2 (N=284, 289, 282, 192, 97)	15 Participants	18 Participants Interval 0.0 to 0.0	26 Participants Interval 0.0 to 0.0	11 Participants Interval 0.0 to 0.0	12 Participants Interval 0.0 to 0.0
Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. Dengue serotype 3 (N=284, 289, 282, 192, 97)	16 Participants	18 Participants Interval 0.0 to 0.0	27 Participants Interval 0.0 to 0.0	12 Participants Interval 0.0 to 0.0	11 Participants Interval 0.0 to 0.0
Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. Dengue serotype 4 (N=284, 289, 282, 192, 97)	10 Participants	6 Participants Interval 0.0 to 0.0	13 Participants Interval 0.0 to 0.0	7 Participants Interval 0.0 to 0.0	8 Participants Interval 0.0 to 0.0

Adverse Events

JE-CV GPO MBP (Lot 1)

Serious events: 10 serious events

Other events: 91 other events

Deaths: 0 deaths

JE-CV GPO MBP (Lot 2)

Serious events: 17 serious events

Other events: 99 other events

Deaths: 0 deaths

JE-CV GPO MBP (Lot 3)

Serious events: 13 serious events

Other events: 87 other events

Deaths: 0 deaths

JE-CV WRAIR

Serious events: 7 serious events

Other events: 65 other events

Deaths: 0 deaths

Hepatitis A

Serious events: 7 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	JE-CV GPO MBP (Lot 1) n=302 participants at risk Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1	JE-CV GPO MBP (Lot 2) n=299 participants at risk Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	JE-CV GPO MBP (Lot 3) n=297 participants at risk Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3	JE-CV WRAIR n=199 participants at risk Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Hepatitis A n=102 participants at risk Participants 12 to 18 months of age received Hepatitis A vaccine
Infections and infestations Bronchiolitis	0.66% 2/302 • Number of events 2 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/299 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/297 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/199 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/102 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Infections and infestations Cellulitis	0.00% 0/302 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/299 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.67% 2/297 • Number of events 2 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/199 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/102 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Infections and infestations Gastroenteritis	0.99% 3/302 • Number of events 3 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	1.3% 4/299 • Number of events 4 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	1.3% 4/297 • Number of events 4 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.50% 1/199 • Number of events 1 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/102 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Infections and infestations Pneumonia	0.99% 3/302 • Number of events 3 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	1.0% 3/299 • Number of events 3 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	1.0% 3/297 • Number of events 3 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	1.0% 2/199 • Number of events 2 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.98% 1/102 • Number of events 1 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Infections and infestations Pneumonia bacterial	0.00% 0/302 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/299 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/297 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/199 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	2.0% 2/102 • Number of events 2 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Infections and infestations Urinary tract infection	0.00% 0/302 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	1.0% 3/299 • Number of events 3 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/297 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/199 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/102 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Nervous system disorders Febrile convulsion	0.66% 2/302 • Number of events 2 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	2.0% 6/299 • Number of events 6 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	1.3% 4/297 • Number of events 4 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.50% 1/199 • Number of events 1 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	2.9% 3/102 • Number of events 4 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Infections and infestations Amoebiasis	0.00% 0/302 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/299 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/297 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.50% 1/199 • Number of events 1 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/102 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Infections and infestations Bronchitis	0.00% 0/302 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.67% 2/299 • Number of events 2 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/297 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/199 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/102 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Infections and infestations Gastroenteritis viral	0.33% 1/302 • Number of events 1 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/299 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/297 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/199 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/102 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Infections and infestations Influenza	0.33% 1/302 • Number of events 1 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/299 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/297 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/199 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/102 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Infections and infestations Pneumonia viral	0.00% 0/302 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/299 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/297 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.50% 1/199 • Number of events 1 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/102 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Infections and infestations Varicella	0.00% 0/302 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/299 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/297 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.50% 1/199 • Number of events 1 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/102 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Infections and infestations Viral infection	0.00% 0/302 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.67% 2/299 • Number of events 2 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/297 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/199 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.98% 1/102 • Number of events 1 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular yolk sac tumour stage III	0.00% 0/302 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/299 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/297 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.50% 1/199 • Number of events 1 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/102 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Respiratory, thoracic and mediastinal disorders Asthma	0.33% 1/302 • Number of events 1 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/299 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/297 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/199 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.00% 0/102 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.

Other adverse events

Measure	JE-CV GPO MBP (Lot 1) n=302 participants at risk Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1	JE-CV GPO MBP (Lot 2) n=299 participants at risk Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	JE-CV GPO MBP (Lot 3) n=297 participants at risk Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3	JE-CV WRAIR n=199 participants at risk Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Hepatitis A n=102 participants at risk Participants 12 to 18 months of age received Hepatitis A vaccine
General disorders Injection site swelling	7.3% 22/302 • Number of events 22 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	6.7% 20/299 • Number of events 20 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	7.1% 21/297 • Number of events 21 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	6.5% 13/199 • Number of events 13 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	3.9% 4/102 • Number of events 4 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
General disorders Pyrexia	0.66% 2/302 • Number of events 2 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	2.0% 6/299 • Number of events 6 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	2.0% 6/297 • Number of events 6 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	5.0% 10/199 • Number of events 10 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	0.98% 1/102 • Number of events 1 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Infections and infestations Gastroenteritis	6.3% 19/302 • Number of events 21 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	6.0% 18/299 • Number of events 19 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	3.7% 11/297 • Number of events 11 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	5.0% 10/199 • Number of events 11 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	4.9% 5/102 • Number of events 5 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Infections and infestations Nasopharyngitis	7.9% 24/302 • Number of events 25 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	6.0% 18/299 • Number of events 18 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	7.4% 22/297 • Number of events 22 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	10.6% 21/199 • Number of events 26 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	4.9% 5/102 • Number of events 5 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Infections and infestations Upper respiratory tract infection	27.8% 84/302 • Number of events 99 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	26.1% 78/299 • Number of events 88 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	24.2% 72/297 • Number of events 79 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	26.1% 52/199 • Number of events 58 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	35.3% 36/102 • Number of events 42 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
General disorders Injection site tenderness	19.2% 58/302 • Number of events 58 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	19.7% 59/299 • Number of events 59 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	22.6% 67/297 • Number of events 67 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	29.6% 59/199 • Number of events 59 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	17.6% 18/102 • Number of events 18 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
General disorders Injection site erythema	21.2% 64/302 • Number of events 64 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	21.1% 63/299 • Number of events 63 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	29.3% 87/297 • Number of events 87 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	27.1% 54/199 • Number of events 54 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	25.5% 26/102 • Number of events 26 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
General disorders Fever	16.9% 51/302 • Number of events 51 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	20.7% 62/299 • Number of events 62 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	21.5% 64/297 • Number of events 64 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	24.1% 48/199 • Number of events 48 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	20.6% 21/102 • Number of events 21 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Gastrointestinal disorders Vomiting	19.9% 60/302 • Number of events 60 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	19.1% 57/299 • Number of events 57 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	17.8% 53/297 • Number of events 53 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	19.6% 39/199 • Number of events 39 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	15.7% 16/102 • Number of events 16 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Psychiatric disorders Crying Abnormal	19.2% 58/302 • Number of events 58 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	18.1% 54/299 • Number of events 54 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	16.8% 50/297 • Number of events 50 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	20.6% 41/199 • Number of events 41 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	20.6% 21/102 • Number of events 21 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Nervous system disorders Drowsiness	19.2% 58/302 • Number of events 58 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	17.7% 53/299 • Number of events 53 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	17.8% 53/297 • Number of events 53 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	19.1% 38/199 • Number of events 38 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	19.6% 20/102 • Number of events 20 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Metabolism and nutrition disorders Appetite Lost	27.2% 82/302 • Number of events 82 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	23.7% 71/299 • Number of events 71 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	24.9% 74/297 • Number of events 74 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	28.6% 57/199 • Number of events 57 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	26.5% 27/102 • Number of events 27 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
Psychiatric disorders Irritability	30.1% 91/302 • Number of events 91 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	26.4% 79/299 • Number of events 79 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	26.6% 79/297 • Number of events 79 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	32.7% 65/199 • Number of events 65 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.	27.5% 28/102 • Number of events 28 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: RegistryContactUs@sanofipasteur.com

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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Restriction type: OTHER