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
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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:
unchecked 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.
unchecked 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.


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