A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
|Japanese Encephalitis||Biological: ChimeriVax™-JE Biological: JE-VAX®||Phase 3|
|Study Design:||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®)|
- 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).
|Study Start Date:||November 2005|
|Study Completion Date:||November 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
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)
Please refer to this study by its ClinicalTrials.gov identifier: 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|