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| Descriptive Information Fields | |||||
| Brief Title † | Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years | ||||
| Official Title † | Open Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years | ||||
| Brief Summary | The objective of this study is to establish the earliest time point at which vaccines are expected to show seropositive antibody levels after vaccination with FSME-IMMUN 0.5 mL using a rapid immunization schedule (2 vaccinations administered 12 +/- 2 days apart. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Encephalitis, Tick-Borne | ||||
| Intervention † | Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | |||||
| Start Date † | March 2004 | ||||
| Completion Date | May 2004 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | Belgium | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00161954 | ||||
| Organization ID | 225 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Baxter Healthcare Corporation | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Baxter Healthcare Corporation | ||||
| Verification Date | October 2006 | ||||
| First Received Date † | September 8, 2005 | ||||
| Last Updated Date | October 19, 2006 | ||||