A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00314145
First received: April 11, 2006
Last updated: December 4, 2012
Last verified: December 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Japanese Encephalitis |
Biological: ChimeriVax™-JE Biological: JE-VAX® |
Phase 3 |
| 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 |
| 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®) |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.
- 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 ] [ Designated as safety issue: No ]
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:
- 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 ] [ Designated as safety issue: No ]Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).
- 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 ] [ Designated as safety issue: No ]Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).
| Enrollment: | 820 |
| Study Start Date: | November 2005 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
Other Name: ChimeriVax™-JE
|
|
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)
Other Name: JE-VAX®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314145
Locations
| 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
| Principal Investigator: | Luis Angles, M.D. | Heart of America Research Institute |
More Information
No publications provided by Sanofi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00314145 History of Changes |
| Other Study ID Numbers: | H-040-009 |
| 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 |
Additional relevant MeSH terms:
|
Encephalitis Encephalitis, Japanese Central Nervous System Viral Diseases Virus Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Central Nervous System Infections Encephalitis, Arbovirus Arbovirus Infections Encephalitis, Viral RNA Virus Infections Flavivirus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 21, 2013