Not Yet RecruitingPhase 3ACTRN12605000680662
Safety and Tolerability Study of the JE Vaccine IC51
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51(JE-PIV).
Sponsor
Intercell AG
Enrollment
600 participants
Start Date
Oct 12, 2006
Study Type
Interventional
Conditions
Eligibility
Sex: Both males and femalesMin Age: 18 Yearss
Inclusion Criteria1
- Written informed consent obtained prior to study entry.
Exclusion Criteria1
- Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine- History of any previous JE vaccination- Immunodeficiency including post-organ-transplantation or immunosuppressive therapy- A family history of congenital or hereditary immunodeficiency- History of autoimmune disease- Any acute infections within 2 weeks prior to enrollment- Known or suspected HIV Infection- Pregnancy, lactation or unreliable contraception in female subjects.
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Interventions
A double-blind, randomized controlled Phase III study to investigate the safety and the tolerability of the JE vaccine IC51.The duration of the treatment including a follow-up period is 56 days.
A double-blind, randomized controlled Phase III study to investigate the safety and the tolerability of the JE vaccine IC51.The duration of the treatment including a follow-up period is 56 days.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12605000680662