We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    H-040-009
Previous Study | Return to List | Next Study

A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00314145
Recruitment Status : Completed
First Posted : April 13, 2006
Results First Posted : December 5, 2012
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Biological: ChimeriVax™-JE Biological: JE-VAX® Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 820 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multicentre, Randomized, Double-blind, Phase III Study of The Comparative Immunogenicity, Safety and Tolerability of Two Japanese Encephalitis Vaccines (ChimeriVax™-JE and JE-VAX®)
Study Start Date : November 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Ixiaro JE-Vax

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: ChimeriVax™-JE
Participants received dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine and saline placebo into different arms.
 Biological: ChimeriVax™-JE
0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline)
Active Comparator: JE-VAX®
Participants received 1 dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a dose of saline placebo into a different arm on Day 30.
 Biological: JE-VAX®
0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination [ Time Frame: Up to Day 60 post-first vaccination ]
    Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.

  2. Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® [ Time Frame: Day 0 (Pre-vaccination) up to 60 days post-first vaccination ]

    Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported.

    Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash.



Secondary Outcome Measures :
  1. Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination [ Time Frame: Up to Day 60 post-first vaccination ]
    Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).

  2. Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination [ Time Frame: Day 60 post-first vaccination ]
    Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects aged 18 or above
  • Subjects in good general health.
  • Females must have negative pregnancy test and be using adequate form of contraception

Exclusion Criteria:

  • History of vaccination/infection with JE or Yellow fever or other flaviviruses
  • History of residence/travel to flavivirus endemic regions
  • History of anaphylaxis/serious adverse reactions
  • Administration of vaccine within 30 days of study or during treatment period
  • Clinically significant physical exam/medical history/lab abnormalities
  • Pregnancy
  • Excessive alcohol/drug abuse
  • Hypersensitivity to constituents of JE-VAX®
  • Blood transfusion/treatment with blood product within 6months of study and during study treatment period
  • Known/suspected immunodeficiency
  • Compromised blood brain barrier
  • Employees of Clinical Research Organization (CRO)/study site staff
  • Any other condition which would exclude subject.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314145


Locations
Layout table for location information
United States, Illinois
Chicago, Illinois, United States, 60610
United States, Kansas
Shawnee Mission, Kansas, United States, 66216
United States, Montana
Missoula, Montana, United States, 59802
United States, Texas
Dallas, Texas, United States, 75231
United States, Washington
Tacoma, Washington, United States, 98403
Australia
Adelaide, Australia
Melbourne, Australia
New South Wales, Australia
Queensland, Australia
Victoria, Australia
Sponsors and Collaborators
Sanofi
Investigators
Layout table for investigator information
Principal Investigator: Luis Angles, M.D. Heart of America Research Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00314145    
Other Study ID Numbers: H-040-009
First Posted: April 13, 2006    Key Record Dates
Results First Posted: December 5, 2012
Last Update Posted: December 6, 2012
Last Verified: December 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Encephalitis, Japanese
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Central Nervous System Infections
 Infections
Infectious Encephalitis
Arbovirus Infections
Vector Borne Diseases
Virus Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections