Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT00441259

First received: February 27, 2007

Last updated: July 24, 2012

Last verified: July 2012

History of Changes

Results First Received: June 6, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Japanese Encephalitis
Interventions:	Biological: ChimeriVax™-JE Biological: Japanese Encephalitis Inactivated Mouse Brain Vaccine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled and vaccinated from 03 January 2007 to 13 January 2009 at 3 clinical centers in India.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 96 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Reporting Groups

	Description
ChimeriVax™-JE	Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
Mouse Brain Derived Vaccine	Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.

Participant Flow: Overall Study

	ChimeriVax™-JE	Mouse Brain Derived Vaccine
STARTED	48	48
COMPLETED	48	48
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
ChimeriVax™-JE	Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
Mouse Brain Derived Vaccine	Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
Total	Total of all reporting groups

Baseline Measures

	ChimeriVax™-JE	Mouse Brain Derived Vaccine	Total
Number of Participants [units: participants]	48	48	96
Age [units: participants]
<=18 years	48	48	96
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: Years] Mean ± Standard Deviation	3.8 ± 2.98	3.7 ± 2.89	3.7 ± 2.52
Gender [units: participants]
Female	27	21	48
Male	21	27	48
Region of Enrollment [units: Participants]
India	48	48	96

Outcome Measures

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1. Primary:

Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine [ Time Frame: Day 14 up to Day 42 Post-vaccination ]

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2. Primary:

Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine [ Time Frame: Day 14 up to Day 42 Post-vaccination ]

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3. Primary:

Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine [ Time Frame: Day 42 Post-vaccination ]

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4. Primary:

Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine [ Time Frame: Day 42 Post Dose 1 ]

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5. Secondary:

Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine [ Time Frame: Day 42 Post Dose 1 ]

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6. Secondary:

Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine [ Time Frame: Day 42 Post-vaccination ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com

No publications provided

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00441259 History of Changes
Other Study ID Numbers:	H-040-004
Study First Received:	February 27, 2007
Results First Received:	June 6, 2012
Last Updated:	July 24, 2012
Health Authority:	United States: Food and Drug Administration India: Drugs Controller General of India

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