Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00595309
• Date of registration: 04/01/2008
• Prospective Registration: No
• Primary sponsor: Valneva Austria GmbH
• Public title: Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
• Scientific title: Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 on Long Term Immunogenicity. An Uncontrolled, Open-label Phase 3 Study.
• Date of first enrolment: December 2007
• Target sample size: 198
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00595309
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Austria, Germany

Contacts

• Name: Susanne Eder
• Affiliation: Valneva Austria GmbH

Key inclusion & exclusion criteria

Main Inclusion Criteria:

- Healthy adults who completed the primary immunization in study IC51 309

- Male and female healthy subjects 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: All

Health Condition(s) or Problem(s) studied

Japanese Encephalitis

Intervention(s)

Biological: IC51

Primary Outcome(s)

Seroconversion Rate [Time Frame: at Month 12 after booster]

Secondary Outcome(s)

Safety and Adverse Events [Time Frame: up to Month 12 after booster]

Geometric Mean Titer [Time Frame: D28, Month 6 and Month 12 after booster]

Seroconversion [Time Frame: at D28 and Month 6 after booster]

Secondary ID(s)

IC51-311

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/06/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00595309