Trial record 1 of 2 for: JEC12

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Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers

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ClinicalTrials.gov Identifier: NCT01396512

Recruitment Status : Completed

First Posted : July 18, 2011

Results First Posted : April 25, 2014

Last Update Posted : April 25, 2014

Sponsor:

Information provided by (Responsible Party):

Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions	Japanese Encephalitis Japanese Encephalitis Virus Disease
Interventions	Biological: Live attenuated Japanese encephalitis chimeric virus vaccine Biological: Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine)
Enrollment	274

Participant Flow

Recruitment Details	The study participants were enrolled from 12 July 2011 to 28 September 2012 at 10 clinic centers in South Korea.
Pre-assignment Details	A total of 274 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.


Arm/Group Title	IMOJEV™ Vaccine Group	CD.JEVAX™ Vaccine Group
Arm/Group Description	Participants age 12 to 24 months re...	Participants age 12 to 24 months re...
Arm/Group Description	Participants age 12 to 24 months received one dose of IMOJEV™	Participants age 12 to 24 months received one dose of CD.JEVAX™
Period Title: Overall Study
Started	137	137
Completed	137	136
Not Completed	0	1
Reason Not Completed
Withdrawal by Subject	0	1

Baseline Characteristics

Arm/Group Title		IMOJEV™ Vaccine Group	CD.JEVAX™ Vaccine Group	Total
Arm/Group Description		Participants age 12 to 24 months re...	Participants age 12 to 24 months re...	Total of all reporting groups
Arm/Group Description		Participants age 12 to 24 months received one dose of IMOJEV™	Participants age 12 to 24 months received one dose of CD.JEVAX™	Total of all reporting groups
Overall Number of Baseline Participants		137	137	274
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	137 participants	137 participants	274 participants
	<=18 years	137 100.0%	137 100.0%	274 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous Mean (Standard Deviation) Unit of measure: Months
	Number Analyzed	137 participants	137 participants	274 participants
		14.0 (2.0)	14.3 (2.2)	14.2 (2.1)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	137 participants	137 participants	274 participants
	Female	58 42.3%	57 41.6%	115 42.0%
	Male	79 57.7%	80 58.4%	159 58.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
South Korea	Number Analyzed	137 participants	137 participants	274 participants
South Korea		137	137	274

Outcome Measures

1.Primary Outcome


Title	Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Description	Immunogenicity assessed using a Japanese encephalitis chimeric virus (...
Description	Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline.
Time Frame	Day 28 post-vaccination

Outcome Measure Data

Analysis Population Description

Seroconversion to JE-CV was assessed in the Per-Protocol Analysis Set.


Arm/Group Title	IMOJEV™ Vaccine Group	CD.JEVAX™ Vaccine Group
Arm/Group Description:	Participants age 12 to 24 months re...	Participants age 12 to 24 months re...
Arm/Group Description:	Participants age 12 to 24 months received one dose of IMOJEV™	Participants age 12 to 24 months received one dose of CD.JEVAX™
Overall Number of Participants Analyzed	119	117
Measure Type: Number Unit of Measure: Percentage of Participants
	100	99.1

2.Secondary Outcome


Title	Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Description	Geometric mean titers we...
Description	Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). JE-CV PRNT50 antibody titer >10 (1/dil, Day 0)
Time Frame	Day 0 (pre-vaccination) and Day 28 post-vaccination

Outcome Measure Data

Analysis Population Description

Geometric mean titers against the JE-CV was assessed in the Per-Protocol Analysis Set.


Arm/Group Title	IMOJEV™ Vaccine Group	CD.JEVAX™ Vaccine Group
Arm/Group Description:	Participants age 12 to 24 months re...	Participants age 12 to 24 months re...
Arm/Group Description:	Participants age 12 to 24 months received one dose of IMOJEV™	Participants age 12 to 24 months received one dose of CD.JEVAX™
Overall Number of Participants Analyzed	119	117
Geometric Mean (95% Confidence Interval) Unit of Measure: Titers
JE-CV PRNT50 antibody titer (pre-vaccination)	5.0 (5.0 to 5.0)	5.0 (5.0 to 5.0)
JE-CV PRNT50 antibody titer (post-vaccination)	908 (656 to 1256)	579 (427 to 784)

3.Secondary Outcome


Title	Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Description	Immunogenicity was assessed using a Japanese encephalitis chimeric vir...
Description	Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.
Time Frame	Day 0 (pre-vaccination) and Day 28 post-vaccination

Outcome Measure Data

Analysis Population Description

Seroprotection against JE-CV was assessed in the Per-Protocol Analysis Set.


Arm/Group Title	IMOJEV™ Vaccine Group	CD.JEVAX™ Vaccine Group
Arm/Group Description:	Participants age 12 to 24 months re...	Participants age 12 to 24 months re...
Arm/Group Description:	Participants age 12 to 24 months received one dose of IMOJEV™	Participants age 12 to 24 months received one dose of CD.JEVAX™
Overall Number of Participants Analyzed	119	117
Measure Type: Number Unit of Measure: Participants
JE-CV PRNT50 antibody titer ≥10 (1/dil, Day 0)	0	0
JE-CV PRNT50 antibody titer ≥10 (1/dil, Day 28)	119	116

4.Secondary Outcome


Title	Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Description	Solicited injection site: Pain, Erythema, and Swelling; Solicited syst...
Description	Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling longest diameter ≥50 mm. Grade 3 systemic reactions: Fever >39.5°C; Vomiting ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - sleeping most of the time or difficult to wake; Appetite Loss - refuses ≥3 feeds or most feeds; Irritability - inconsolable.
Time Frame	Day 0 up to Day 14 post-vaccination

Outcome Measure Data

Analysis Population Description

Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.


Arm/Group Title	IMOJEV™ Vaccine Group	CD.JEVAX™ Vaccine Group
Arm/Group Description:	Participants age 12 to 24 months re...	Participants age 12 to 24 months re...
Arm/Group Description:	Participants age 12 to 24 months received one dose of IMOJEV™	Participants age 12 to 24 months received one dose of CD.JEVAX™
Overall Number of Participants Analyzed	137	137
Measure Type: Number Unit of Measure: Participants
Injection site Pain (N = 137, 137)	35	38
Grade 3 Injection site Pain (N = 137, 137)	0	1
Injection site Erythema (N = 137, 137)	23	33
Grade 3 Injection site Erythema (N = 137, 137)	0	0
Injection site Swelling (N = 137, 137)	6	10
Grade 3 Injection site Swelling (N = 137, 137)	0	0
Fever (N = 134, 136)	33	34
Grade 3 Fever (N = 134, 136)	1	1
Vomiting (N = 137, 137)	9	14
Grade 3 Vomiting (N = 137, 137)	1	2
Crying Abnormal (N = 137, 137)	27	35
Grade 3 Crying Abnormal (N = 137, 137)	2	3
Drowsiness (N = 137, 137)	23	33
Grade 3 Drowsiness (N = 137, 137)	0	1
Appetite Loss (N = 137, 137)	38	40
Grade 3 Appetite Loss (N = 137, 137)	4	1
Irritability (N = 137, 137)	31	36
Grade 3 Irritability (N = 137, 137)	1	5

Adverse Events

Time Frame	Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	IMOJEV™ Vaccine Group		CD.JEVAX™ Vaccine Group
Arm/Group Description	Participants age 12 to 24 months re...		Participants age 12 to 24 months re...
Arm/Group Description	Participants age 12 to 24 months received one dose of IMOJEV™		Participants age 12 to 24 months received one dose of CD.JEVAX™
All-Cause Mortality
	IMOJEV™ Vaccine Group		CD.JEVAX™ Vaccine Group
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	IMOJEV™ Vaccine Group		CD.JEVAX™ Vaccine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/137 (12.41%)		18/137 (13.14%)
Gastrointestinal disorders
Intestinal obstruction ^* 1	1/137 (0.73%)	1	0/137 (0.00%)	0
Intussusception ^* 1	1/137 (0.73%)	1	0/137 (0.00%)	0
Stomatitis ^* 1	0/137 (0.00%)	0	1/137 (0.73%)	1
General disorders
Pyrexia ^* 1	1/137 (0.73%)	1	2/137 (1.46%)	2
Hepatobiliary disorders
Hepatitis ^* 1	0/137 (0.00%)	0	1/137 (0.73%)	1
Infections and infestations
Bronchiolitis ^* 1	1/137 (0.73%)	1	1/137 (0.73%)	1
Bronchitis ^* 1	2/137 (1.46%)	2	1/137 (0.73%)	2
Croup infectious ^* 1	0/137 (0.00%)	0	1/137 (0.73%)	1
Gastroenteritis ^* 1	1/137 (0.73%)	1	3/137 (2.19%)	3
Hand foot and mouth disease ^* 1	0/137 (0.00%)	0	1/137 (0.73%)	1
Herpangina ^* 1	1/137 (0.73%)	1	0/137 (0.00%)	0
Lymph node abscess ^* 1	1/137 (0.73%)	1	0/137 (0.00%)	0
Meningitis aseptic ^* 1	1/137 (0.73%)	1	0/137 (0.00%)	0
Pharyngitis ^* 1	2/137 (1.46%)	2	1/137 (0.73%)	1
Pharyngotonsillitis ^* 1	1/137 (0.73%)	1	1/137 (0.73%)	1
Pneumonia ^* 1	5/137 (3.65%)	5	3/137 (2.19%)	3
Urinary tract infection ^* 1	0/137 (0.00%)	0	1/137 (0.73%)	2
Nervous system disorders
Febrile convulsion ^* 1	0/137 (0.00%)	0	1/137 (0.73%)	1
Kawasaki's disease ^* 1	2/137 (1.46%)	2	1/137 (0.73%)	1
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA 13.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5.00%
	IMOJEV™ Vaccine Group		CD.JEVAX™ Vaccine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	74/137 (54.01%)		69/137 (50.36%)
Gastrointestinal disorders
Diarrhea ^* 1	9/137 (6.57%)	9	3/137 (2.19%)	3
Vomiting ^† 1	9/137 (6.57%)	9	14/137 (10.22%)	14
General disorders
Pyrexia ^* 1	8/137 (5.84%)	8	9/137 (6.57%)	9
Injection site Pain ^† 1	35/137 (25.55%)	35	38/137 (27.74%)	38
Injection site Erythema ^† 1	23/137 (16.79%)	23	33/137 (24.09%)	33
Injection site Swelling ^† 1	6/137 (4.38%)	6	10/137 (7.30%)	10
Fever ^† 1	33/134 (24.63%)	33	34/136 (25.00%)	34
Infections and infestations
Bronchitis ^* 1	9/137 (6.57%)	9	6/137 (4.38%)	7
Gastroenteritis ^* 1	4/137 (2.92%)	4	7/137 (5.11%)	8
Nasopharyngitis ^* 1	42/137 (30.66%)	54	38/137 (27.74%)	44
Otitis media ^* 1	6/137 (4.38%)	7	8/137 (5.84%)	9
Upper respiratory tract infection ^* 1	11/137 (8.03%)	13	4/137 (2.92%)	5
Metabolism and nutrition disorders
Appetite Loss ^† 1	38/137 (27.74%)	38	40/137 (29.20%)	40
Nervous system disorders
Drowsiness ^† 1	23/137 (16.79%)	23	33/137 (24.09%)	33
Psychiatric disorders
Crying Abnormal ^† 1	27/137 (19.71%)	27	35/137 (25.55%)	35
Irritability ^† 1	31/137 (22.63%)	31	36/137 (26.28%)	36
Respiratory, thoracic and mediastinal disorders
Rhinorrhea ^* 1	5/137 (3.65%)	7	7/137 (5.11%)	8
† Indicates events were collected by systematic assessment * Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA 13.0

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

Layout table for Results Point of Contact information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kim DS, Houillon G, Jang GC, Cha SH, Choi SH, Lee J, Kim HM, Kim JH, Kang JH, Kim JH, Kim KH, Kim HS, Bang J, Naimi Z, Bosch-Castells V, Boaz M, Bouckenooghe A. A randomized study of the immunogenicity and safety of Japanese encephalitis chimeric virus vaccine (JE-CV) in comparison with SA14-14-2 vaccine in children in the Republic of Korea. Hum Vaccin Immunother. 2014;10(9):2656-63. doi: 10.4161/hv.29743. Epub 2014 Nov 6.

Layout table for additonal information

Responsible Party:	Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:	NCT01396512
Other Study ID Numbers:	JEC12 U1111-1117-7378 ( Other Identifier: WHO )
First Submitted:	July 14, 2011
First Posted:	July 18, 2011
Results First Submitted:	March 24, 2014
Results First Posted:	April 25, 2014
Last Update Posted:	April 25, 2014

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