Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
Phase 3
Completed
- Conditions
- Japanese Encephalitis
- Interventions
- Biological: IC51
- Registration Number
- NCT00595309
- Lead Sponsor
- Valneva Austria GmbH
- Brief Summary
The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 198
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A IC51 -
- Primary Outcome Measures
Name Time Method Seroconversion Rate at Month 12 after booster
- Secondary Outcome Measures
Name Time Method Geometric Mean Titer D28, Month 6 and Month 12 after booster Safety and Adverse Events up to Month 12 after booster Seroconversion at D28 and Month 6 after booster
Trial Locations
- Locations (3)
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
🇦🇹Vienna, Austria
Zentrum für Reisemedizin, Dependance für klinische Studien
🇦🇹Vienna, Austria
Berliner Zentrum Reise- und Tropenmedizin
🇩🇪Berlin, Germany