Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT00981630

First received: September 21, 2009

Last updated: November 6, 2012

Last verified: November 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
Condition:	Japanese Encephalitis
Interventions:	Biological: Live attenuated Japanese encephalitis virus Biological: ChimeriVax™ diluent (Placebo)

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 from 01 December 2004 to 31 January 2005 at 2 clinical centers in Australia.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 128 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

Reporting Groups

	Description
ChimeriVax™-JE 3 log10 PFU	All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
ChimeriVax™-JE 4 log10 PFU	All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
ChimeriVax™-JE 5 log10 PFU	All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
Placebo	All participants received a single dose of Placebo (diluent) on Day 0.

Participant Flow: Overall Study

	ChimeriVax™-JE 3 log10 PFU	ChimeriVax™-JE 4 log10 PFU	ChimeriVax™-JE 5 log10 PFU	Placebo
STARTED	32	32	32	32
COMPLETED	32	32	32	32
NOT COMPLETED	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
ChimeriVax™-JE 3 log10 PFU	All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
ChimeriVax™-JE 4 log10 PFU	All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
ChimeriVax™-JE 5 log10 PFU	All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
Placebo	All participants received a single dose of Placebo (diluent) on Day 0.
Total	Total of all reporting groups

Baseline Measures

	ChimeriVax™-JE 3 log10 PFU	ChimeriVax™-JE 4 log10 PFU	ChimeriVax™-JE 5 log10 PFU	Placebo	Total
Number of Participants [units: participants]	32	32	32	32	128
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	32	32	32	32	128
>=65 years	0	0	0	0	0
Age [units: Years] Mean ± Standard Deviation	29.3 ± 7.62	26.7 ± 9.17	27.4 ± 8.31	29.4 ± 8.43	28.2 ± 8.38
Gender [units: participants]
Female	15	18	15	16	64
Male	17	14	17	16	64
Region of Enrollment [units: Participants]
Australia	32	32	32	32	128

Outcome Measures

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1. Primary:

Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain, 28 Days After Completion of the Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or A Placebo [ Time Frame: Day 11 and Day 30 post-vaccination ]

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2. Primary:

Number of Participants Who Seroconverted to Wild Type JE Virus Strains After Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo [ Time Frame: Day 30 post-vaccination ]

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3. Primary:

Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo [ Time Frame: Day 0 (post-vaccination) up to Day 30 post-vaccination ]

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4. Secondary:

Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo [ Time Frame: Day 11 and Day 30 post-vaccination ]

Show Outcome Measure 4

5. Secondary:

Geometric Mean Titers to Japanese Encephalitis (Wild Type JE Virus Strains) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo [ Time Frame: Day 30 post-vaccination ]

Show Outcome Measure 5

6. Secondary:

Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo [ Time Frame: Day 30 up to 12 months 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:	NCT00981630 History of Changes
Other Study ID Numbers:	H-040-007
Study First Received:	September 21, 2009
Results First Received:	November 6, 2012
Last Updated:	November 6, 2012
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration United States: Food and Drug Administration

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