Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00595465
• Date of registration: 04/01/2008
• Primary sponsor: Intercell AG
• Public title: Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51
• Scientific title: Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.
• Date of first enrolment: December 2007
• Target sample size: 389
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00595465
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Countries of recruitment

Austria, Germany

Contacts

• Name: Nicole Haas
• Affiliation: Intercell AG

Key inclusion & exclusion criteria

Main Inclusion Criteria:

- Male and female healthy adults aged at least 18 years, with written informed consent
and either no childbearing potential or negative pregnancy test

Main Exclusion Criteria:

- History of immunodeficiency or immunosuppressive therapy,

- Known Human Immunodeficiency Virus (HIV); OR

- Drug addiction including alcohol dependence



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Japanese Encephalitis

Intervention(s)

Biological: Japanese Encephalitis purified inactivated vaccine

Primary Outcome(s)

Geometric mean titer [Time Frame: No]

Secondary Outcome(s)

Safety and Adverse Events [Time Frame: Yes]

Seroconversion rate [Time Frame: No]

Secondary ID(s)

IC51-310

Source(s) of Monetary Support

Please refer to primary and secondary sponsors