Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT00314132

First received: April 11, 2006

Last updated: December 4, 2012

Last verified: December 2012

History of Changes

Results First Received: November 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
Conditions:	Encephalitis Japanese Encephalitis
Interventions:	Biological: ChimeriVax-JE, Japanese Encephalitis vaccine Biological: 0.9% Saline

Participant Flow

Hide Participant Flow

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 10 October 2005 to 30 March 2006 at 6 clinical centers in Australia and 16 clinical centers in the US.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 2004 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

Reporting Groups

	Description
Placebo	Participants received a single injection of placebo on Day 0.
ChimeriVax™-JE 4 log10 PFU Vaccine	Participants received a single injection of ChimeriVax™-JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.

Participant Flow: Overall Study

	Placebo	ChimeriVax™-JE 4 log10 PFU Vaccine
STARTED	403	1601
COMPLETED	395	1583
NOT COMPLETED	8	18
Lost to Follow-up	3	13
Withdrawal by Subject	3	5
Adverse Event	1	0
Physician Decision	1	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Placebo	Participants received a single injection of placebo on Day 0.
ChimeriVax™-JE 4 log10 PFU Vaccine	Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
Total	Total of all reporting groups

Baseline Measures

	Placebo	ChimeriVax™-JE 4 log10 PFU Vaccine	Total
Number of Participants [units: participants]	403	1601	2004
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	403	1601	2004
>=65 years	0	0	0
Age [units: Years] Mean ± Standard Deviation	34.8 ± 14.12	34.6 ± 14.25	34.7 ± 14.22
Gender [units: participants]
Female	165	721	886
Male	238	880	1118
Region of Enrollment [units: Participants]
United States	263	1201	1464
Australia	140	400	540

Outcome Measures

Show All Outcome Measures

1. Primary:

Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo [ Time Frame: Day 0 up to 30 days post-vaccination ]

Show Outcome Measure 1

2. Primary:

Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo [ Time Frame: Day 0 up to 30 days post-vaccination ]

Show Outcome Measure 2

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide 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.

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 by Sanofi

Publications automatically indexed to this study:

Torresi J, McCarthy K, Feroldi E, Méric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials. Vaccine. 2010 Nov 23;28(50):7993-8000. Epub 2010 Oct 8.

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00314132 History of Changes
Other Study ID Numbers:	H-040-010
Study First Received:	April 11, 2006
Results First Received:	November 6, 2012
Last Updated:	December 4, 2012
Health Authority:	United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration

To Top