A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
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®)
1 other identifier
interventional
820
2 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2005
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 11, 2006
CompletedFirst Posted
Study publicly available on registry
April 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedResults Posted
Study results publicly available
December 5, 2012
CompletedDecember 6, 2012
December 1, 2012
7 months
April 11, 2006
November 6, 2012
December 4, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.
Up to Day 60 post-first vaccination
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
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.
Day 0 (Pre-vaccination) up to 60 days post-first vaccination
Secondary Outcomes (2)
Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Up to Day 60 post-first vaccination
Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Day 60 post-first vaccination
Study Arms (2)
ChimeriVax™-JE
EXPERIMENTALParticipants 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.
JE-VAX®
ACTIVE COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects aged 18 or above
- Subjects in good general health.
- Females must have negative pregnancy test and be using adequate form of contraception
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (10)
Unknown Facility
Chicago, Illinois, 60610, United States
Unknown Facility
Shawnee Mission, Kansas, 66216, United States
Unknown Facility
Missoula, Montana, 59802, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Tacoma, Washington, 98403, United States
Unknown Facility
Adelaide, Australia
Unknown Facility
Melbourne, Australia
Unknown Facility
New South Wales, Australia
Unknown Facility
Queensland, Australia
Unknown Facility
Victoria, Australia
Related Publications (1)
Torresi J, McCarthy K, Feroldi E, Meric 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. doi: 10.1016/j.vaccine.2010.09.035. Epub 2010 Oct 8.
PMID: 20934459DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Luis Angles, M.D.
Heart of America Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2006
First Posted
April 13, 2006
Study Start
November 1, 2005
Primary Completion
June 1, 2006
Study Completion
November 1, 2006
Last Updated
December 6, 2012
Results First Posted
December 5, 2012
Record last verified: 2012-12