A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
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|ClinicalTrials.gov Identifier: NCT00314145|
Recruitment Status : Completed
First Posted : April 13, 2006
Results First Posted : December 5, 2012
Last Update Posted : December 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Japanese Encephalitis||Biological: ChimeriVax™-JE Biological: JE-VAX®||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||820 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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.
0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)
- 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.
- 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.
- 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).
- 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).
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
|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|
|New South Wales, Australia|
|Principal Investigator:||Luis Angles, M.D.||Heart of America Research Institute|