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

• ClinicalTrials.gov Identifier: NCT00735644
• Recruitment Status: Completed
• First Posted: August 15, 2008
• Results First Posted: August 15, 2014
• Last Update Posted: April 21, 2015
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
• Conditions: Japanese Encephalitis; Hepatitis A
• Interventions: Biological: Japanese encephalitis vaccine; Biological: Japanese encephalitis vaccine (Acambis); Biological: Hepatitis A vaccine
• Enrollment: 1200

Participant Flow

Recruitment Details	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.
Pre-assignment Details	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.

Arm/Group Title	JE-CV GPO MBP (Lot 1)	JE-CV GPO MBP (Lot 2)	JE-CV GPO MBP (Lot 3)	JE-CV WRAIR	Hepatitis A
Arm/Group Description	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.	Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	Participants 12 to 18 months of age received one dose of JE- CV from GPO MBP Lot 3	Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Participants 12 to 18 months of age received the Hepatitis A vaccine
Period Title: Overall Study
Started	303	300	296	199	102
Completed	303	298	295	198	102
Not Completed	0	2	1	1	0
Reason Not Completed
Did not receive study vaccine	0	1	0	0	0
Withdrawal by Subject	0	1	1	1	0

Baseline Characteristics

Arm/Group Title		JE CV GPO MBP (Lot 1)	JE-CV GPO MBP (Lot 2)	JE-CV GPO MBP (Lot 3)	JE-CV WRAIR	Hepatitis A	Total
Arm/Group Description		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	Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3	Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Participants 12 to 18 months of age received Hepatitis A vaccine	Total of all reporting groups
Overall Number of Baseline Participants		303	299	296	199	102	1199
Baseline Analysis Population Description		The baseline analysis population represents the participants who have received the trial vaccine or control vaccine (safety analysis set). Data on participants were analyzed and presented according to the vaccine they actually received.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	303 participants	299 participants	296 participants	199 participants	102 participants	1199 participants
	<=18 years	303 100.0%	299 100.0%	296 100.0%	199 100.0%	102 100.0%	1199 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Months
	Number Analyzed	303 participants	299 participants	296 participants	199 participants	102 participants	1199 participants
		14.3 (1.91)	14.5 (1.84)	14.4 (1.88)	14.3 (1.81)	14.3 (1.93)	14.4 (1.87)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	303 participants	299 participants	296 participants	199 participants	102 participants	1199 participants
	Female	155 51.2%	138 46.2%	143 48.3%	94 47.2%	45 44.1%	575 48.0%
	Male	148 48.8%	161 53.8%	153 51.7%	105 52.8%	57 55.9%	624 52.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	303 participants	299 participants	296 participants	199 participants	102 participants	1199 participants
Thailand		123	122	121	82	42	490
Philippines		180	177	175	117	60	709

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots
Description	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.
Time Frame	Day 0 (pre-vaccination) and Day 28 post-vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	JE CV GPO MBP (Lot 1)	JE-CV GPO MBP (Lot 2)	JE-CV GPO MBP (Lot 3)	JE-CV WRAIR	Hepatitis A
Arm/Group Description:	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	Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3	Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Participants 12 to 18 months of age received Hepatitis A vaccine
Overall Number of Participants Analyzed	288	292	286	193	97
Measure Type: Number; Unit of Measure: Participants
JE CV Day 0 (≥10 1/dil; N=288, 290, 285, 192, 0)	0	0	0	0	NA [1]
JE CV Day 28 (≥10 1/dil; N=288, 284, 283, 192, 0)	282	262	267	185	NA [1]

[1]

Anti-Japanese encephalitis chimeric virus vaccine antibodies were not assayed in this group

2. Secondary Outcome

Title	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
Description	Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay.
Time Frame	Day 0 (pre-vaccination) and Day 28 post-vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	JE CV GPO MBP (Lot 1)	JE-CV GPO MBP (Lot 2)	JE-CV GPO MBP (Lot 3)	JE-CV WRAIR	Hepatitis A
Arm/Group Description:	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	Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3	Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Participants 12 to 18 months of age received Hepatitis A vaccine
Overall Number of Participants Analyzed	288	292	286	193	0
Geometric Mean (95% Confidence Interval); Unit of Measure: Titers
Anti JE-CV Day 0 (N=288, 290, 285, 192, 0)	5.17; (5.06 to 5.29)	5.08; (4.99 to 5.17)	5.19; (5.02 to 5.37)	5.09; (4.95 to 5.24)
Anti JE CV Day 28 (N=288, 284, 283, 192, 0)	212; (179 to 252)	167; (138 to 202)	188; (156 to 226)	212; (168 to 268)

3. Secondary Outcome

Title	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
Description	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).
Time Frame	Day 0 (pre-vaccination) and Day 28 post-vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	JE-CV GPO MBP (Lot 1)	JE-CV GPO MBP (Lot 2)	JE-CV GPO MBP (Lot 3)	JE-CV WRAIR	Hepatitis A
Arm/Group Description:	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	Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3	Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Participants 12 to 18 months of age received Hepatitis A vaccine
Overall Number of Participants Analyzed	288	292	286	193	97
Measure Type: Number; Unit of Measure: Participants
JE CV Day 0 (N=288, 290, 285, 192, 0)	10	4	8	2	NA [1]
JE CV Day 28 (N=288, 284, 283, 192, 0)	297	269	276	190	NA [1]

[1]

Japanese encephalitis chimeric virus vaccine antibodies were not measured in this group

4. Secondary Outcome

Title	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
Description	Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay.
Time Frame	Day 0 (pre-vaccination) and Day 28 post-vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	JE-CV GPO MBP (Lot 1)	JE-CV MBP (Lot 2)	JE-CV MBP (Lot 3)	JE-CV WRAIR	Hepatitis A
Arm/Group Description:	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	Participants 12 to 18 months of age received one dose of JE CV from GPO MBP Lot 2 subcutaneously	Participants 12 to 18 months of age received one dose of JE CV from GPO MBP Lot 3 subcutaneously	Participants 12 to 18 months of age received one dose of JE CV from Acambis at WRAIR subcutaneously	Participants 12 to 18 months of age received the Hepatitis vaccine intramuscularly
Overall Number of Participants Analyzed	288	292	286	193	97
Geometric Mean (95% Confidence Interval); Unit of Measure: Titer ratio
	41.1; (34.6 to 48.7)	32.9; (27.3 to 39.8)	36.6; (30.3 to 44.1)	42.2; (33.3 to 53.3)	NA [1]; (NA to NA)

[1]

Participants in this group did not receive a Japanese encephalitis chimeric virus vaccine

5. Secondary Outcome

Title	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.
Description	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.
Time Frame	Day 0 up to Day 14 post-vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	JE CV GPO MBP (Lot 1)	JE-CV GPO MBP (Lot 2)	JE-CV GPO MBP (Lot 3)	JE-CV WRAIR	Hepatitis A
Arm/Group Description:	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	Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3	Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Participants 12 to 18 months of age received Hepatitis A vaccine
Overall Number of Participants Analyzed	302	299	297	199	102
Measure Type: Number; Unit of Measure: Participants
Injection site Tenderness	58	59	67	59	18
Grade 3 Injection site Tenderness	0	0	0	0	0
Injection site Erythema	64	63	87	54	26
Grade 3 Injection site Erythema	0	0	0	0	0
Injection site Swelling	22	20	21	13	4
Grade 3 Injection site Swelling	0	0	0	0	0
Fever	51	62	64	48	21
Grade 3 Fever	3	5	3	1	0
Vomiting	60	57	53	39	16
Grade 3 Vomiting	3	1	1	1	1
Crying Abnormal	58	54	50	41	21
Grade 3 Crying Abnormal	1	0	1	0	0
Drowsiness	58	53	53	38	20
Grade 3 Drowsiness	0	0	0	0	0
Appetite Lost	82	71	74	57	27
Grade 3 Appetite Lost	3	1	1	2	0
Irritability	91	79	79	65	28
Grade 3 Irritability	2	0	1	1	1

6. Other Pre-specified Outcome

Title	Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine.
Description	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.
Time Frame	Day 0 (pre-vaccination)

Outcome Measure Data

Analysis Population Description

Serological status of Flavivirus infection was assessed in the Per-protocol Analysis Set.

Arm/Group Title	JE-CV GPO MBP (Lot 1)	JE-CV GPO MBP (Lot 2)	JE-CV GPO MBP (Lot 3)	JE-CV WRAIR	Hepatitis A
Arm/Group Description:	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	Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2	Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3	Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)	Participants 12 to 18 months of age received Hepatitis A vaccine
Overall Number of Participants Analyzed	288	292	285	192	97
Measure Type: Number; Unit of Measure: Participants
JE CV/dengue FV positive (N=288,290,285,192,97)	19	23	32	15	13
JE CV/dengue FV negative (N=288,290,285,192,97)	265	266	249	176	84
JE CV (N=288, 290, 285, 192, 97)	0	0	0	0	0
Dengue serotype 1 (N=284, 289, 282, 192, 97)	17	19	28	14	13
Dengue serotype 2 (N=284, 289, 282, 192, 97)	15	18	26	11	12
Dengue serotype 3 (N=284, 289, 282, 192, 97)	16	18	27	12	11
Dengue serotype 4 (N=284, 289, 282, 192, 97)	10	6	13	7	8

Adverse Events

Time Frame	Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination.
Adverse Event Reporting Description	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.
Arm/Group Title	JE-CV GPO MBP (Lot 1)		JE-CV GPO MBP (Lot 2)		JE-CV GPO MBP (Lot 3)		JE-CV WRAIR		Hepatitis A
Arm/Group Description	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		Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2		Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3		Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)		Participants 12 to 18 months of age received Hepatitis A vaccine
All-Cause Mortality
	JE-CV GPO MBP (Lot 1)		JE-CV GPO MBP (Lot 2)		JE-CV GPO MBP (Lot 3)		JE-CV WRAIR		Hepatitis A
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--		--/--		--/--
Serious Adverse Events
	JE-CV GPO MBP (Lot 1)		JE-CV GPO MBP (Lot 2)		JE-CV GPO MBP (Lot 3)		JE-CV WRAIR		Hepatitis A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/302 (3.31%)		17/299 (5.69%)		13/297 (4.38%)		7/199 (3.52%)		7/102 (6.86%)
Infections and infestations
Bronchiolitis * 1	2/302 (0.66%)	2	0/299 (0.00%)	0	0/297 (0.00%)	0	0/199 (0.00%)	0	0/102 (0.00%)	0
Cellulitis * 1	0/302 (0.00%)	0	0/299 (0.00%)	0	2/297 (0.67%)	2	0/199 (0.00%)	0	0/102 (0.00%)	0
Gastroenteritis * 1	3/302 (0.99%)	3	4/299 (1.34%)	4	4/297 (1.35%)	4	1/199 (0.50%)	1	0/102 (0.00%)	0
Pneumonia * 1	3/302 (0.99%)	3	3/299 (1.00%)	3	3/297 (1.01%)	3	2/199 (1.01%)	2	1/102 (0.98%)	1
Pneumonia bacterial * 1	0/302 (0.00%)	0	0/299 (0.00%)	0	0/297 (0.00%)	0	0/199 (0.00%)	0	2/102 (1.96%)	2
Urinary tract infection * 1	0/302 (0.00%)	0	3/299 (1.00%)	3	0/297 (0.00%)	0	0/199 (0.00%)	0	0/102 (0.00%)	0
Amoebiasis * 1	0/302 (0.00%)	0	0/299 (0.00%)	0	0/297 (0.00%)	0	1/199 (0.50%)	1	0/102 (0.00%)	0
Bronchitis * 1	0/302 (0.00%)	0	2/299 (0.67%)	2	0/297 (0.00%)	0	0/199 (0.00%)	0	0/102 (0.00%)	0
Gastroenteritis viral * 1	1/302 (0.33%)	1	0/299 (0.00%)	0	0/297 (0.00%)	0	0/199 (0.00%)	0	0/102 (0.00%)	0
Influenza * 1	1/302 (0.33%)	1	0/299 (0.00%)	0	0/297 (0.00%)	0	0/199 (0.00%)	0	0/102 (0.00%)	0
Pneumonia viral * 1	0/302 (0.00%)	0	0/299 (0.00%)	0	0/297 (0.00%)	0	1/199 (0.50%)	1	0/102 (0.00%)	0
Varicella * 1	0/302 (0.00%)	0	0/299 (0.00%)	0	0/297 (0.00%)	0	1/199 (0.50%)	1	0/102 (0.00%)	0
Viral infection * 1	0/302 (0.00%)	0	2/299 (0.67%)	2	0/297 (0.00%)	0	0/199 (0.00%)	0	1/102 (0.98%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular yolk sac tumour stage III * 1	0/302 (0.00%)	0	0/299 (0.00%)	0	0/297 (0.00%)	0	1/199 (0.50%)	1	0/102 (0.00%)	0
Nervous system disorders
Febrile convulsion * 1	2/302 (0.66%)	2	6/299 (2.01%)	6	4/297 (1.35%)	4	1/199 (0.50%)	1	3/102 (2.94%)	4
Respiratory, thoracic and mediastinal disorders
Asthma * 1	1/302 (0.33%)	1	0/299 (0.00%)	0	0/297 (0.00%)	0	0/199 (0.00%)	0	0/102 (0.00%)	0
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 10.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5.00%
	JE-CV GPO MBP (Lot 1)		JE-CV GPO MBP (Lot 2)		JE-CV GPO MBP (Lot 3)		JE-CV WRAIR		Hepatitis A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	91/302 (30.13%)		99/299 (33.11%)		87/297 (29.29%)		65/199 (32.66%)		36/102 (35.29%)
Gastrointestinal disorders
Vomiting † 1	60/302 (19.87%)	60	57/299 (19.06%)	57	53/297 (17.85%)	53	39/199 (19.60%)	39	16/102 (15.69%)	16
General disorders
Pyrexia * 1	2/302 (0.66%)	2	6/299 (2.01%)	6	6/297 (2.02%)	6	10/199 (5.03%)	10	1/102 (0.98%)	1
Injection site tenderness † 1	58/302 (19.21%)	58	59/299 (19.73%)	59	67/297 (22.56%)	67	59/199 (29.65%)	59	18/102 (17.65%)	18
Injection site erythema † 1	64/302 (21.19%)	64	63/299 (21.07%)	63	87/297 (29.29%)	87	54/199 (27.14%)	54	26/102 (25.49%)	26
Injection site swelling † 1	22/302 (7.28%)	22	20/299 (6.69%)	20	21/297 (7.07%)	21	13/199 (6.53%)	13	4/102 (3.92%)	4
Fever † 1	51/302 (16.89%)	51	62/299 (20.74%)	62	64/297 (21.55%)	64	48/199 (24.12%)	48	21/102 (20.59%)	21
Infections and infestations
Gastroenteritis * 1	19/302 (6.29%)	21	18/299 (6.02%)	19	11/297 (3.70%)	11	10/199 (5.03%)	11	5/102 (4.90%)	5
Nasopharyngitis * 1	24/302 (7.95%)	25	18/299 (6.02%)	18	22/297 (7.41%)	22	21/199 (10.55%)	26	5/102 (4.90%)	5
Upper respiratory tract infection * 1	84/302 (27.81%)	99	78/299 (26.09%)	88	72/297 (24.24%)	79	52/199 (26.13%)	58	36/102 (35.29%)	42
Metabolism and nutrition disorders
Appetite Lost † 1	82/302 (27.15%)	82	71/299 (23.75%)	71	74/297 (24.92%)	74	57/199 (28.64%)	57	27/102 (26.47%)	27
Nervous system disorders
Drowsiness † 1	58/302 (19.21%)	58	53/299 (17.73%)	53	53/297 (17.85%)	53	38/199 (19.10%)	38	20/102 (19.61%)	20
Psychiatric disorders
Crying Abnormal † 1	58/302 (19.21%)	58	54/299 (18.06%)	54	50/297 (16.84%)	50	41/199 (20.60%)	41	21/102 (20.59%)	21
Irritability † 1	91/302 (30.13%)	91	79/299 (26.42%)	79	79/297 (26.60%)	79	65/199 (32.66%)	65	28/102 (27.45%)	28
† Indicates events were collected by systematic assessment; * Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 10.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: Medical Director
• Organization: Sanofi Pasteur Inc.
• EMail: RegistryContactUs@sanofipasteur.com

Publications of Results:

Feroldi E, Pancharoen C, Kosalaraksa P, Watanaveeradej V, Phirangkul K, Capeding MR, Boaz M, Gailhardou S, Bouckenooghe A. Single-dose, live-attenuated Japanese encephalitis vaccine in children aged 12-18 months: randomized, controlled phase 3 immunogenicity and safety trial. Hum Vaccin Immunother. 2012 Jul;8(7):929-37. doi: 10.4161/hv.20071. Epub 2012 Jul 1.

Bonaparte M, Dweik B, Feroldi E, Meric C, Bouckenooghe A, Hildreth S, Hu B, Yoksan S, Boaz M. Immune response to live-attenuated Japanese encephalitis vaccine (JE-CV) neutralizes Japanese encephalitis virus isolates from south-east Asia and India. BMC Infect Dis. 2014 Mar 21;14:156. doi: 10.1186/1471-2334-14-156.

• Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
• ClinicalTrials.gov Identifier: NCT00735644
• Other Study ID Numbers: JEC02
• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Results First Submitted: June 25, 2014
• Results First Posted: August 15, 2014
• Last Update Posted: April 21, 2015