ong term persistence and effect of a booster dose of the Japanese encephalitis vaccine IC51 (JE-PIV).

Phase 1

• Conditions: Healthy volunteers: Immunization against Japanese Encephalitis virus (JEV)

• Registration Number: EUCTR2005-000593-41-GB
• Lead Sponsor: Intercell AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-28
• Study Completion: 2009-04-30
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 368

Inclusion Criteria

1. Written informed consent obtained prior to study entry (subjects should give their consent themselves, consent by legal representatives is allowed). Written informed consent should be obtained during participation of IC51-304 study.
2. Subjects correctly included in and having completed study IC51-304 according to the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period
2. Planned administration of another vaccine during the study period
3. Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
4. Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs since last visit of study IC51-304. (For corticosteroids, this will mean prednisone, or equivalent, greater than 0.5 mg/kg/day. Topical and inhaled steroids are allowed.)
5. Positive Pregnancy test, lactation or unreliable contraception, childbearing potential, and willingness to become pregnant, in female subjects up to 30 days after the last vaccination (for details please refer to protocol section 6.4)
6. Inability or unwillingness to provide informed consent and to abide by the requirements of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified