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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00161746 |
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Date of registration:
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08/09/2005 |
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Primary sponsor: |
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Public title:
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Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years
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Scientific title:
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Multicentre Randomized Double-Blind Phase II/III Study on the Safety and Immunogenicity of Three Vaccinations With TICOVAC in Two Dosages in Healthy Children Aged Between Six Months and Three Years |
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Date of first enrolment:
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April 1998 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00161746 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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Countries of recruitment
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Austria
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Contacts
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Name:
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Baxter BioScience Investigator |
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Address:
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Telephone:
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Email:
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Affiliation:
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Baxter Healthcare Corporation |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male and female children aged between 6 and 47 months
- No history of any previous TBE vaccination
- Clinically healthy
- Informed consent provided by the parents
Exclusion Criteria:
- History of allergic reactions, in particular allergic reactions to one of the
components of the vaccine
- Suffering from a disease that cannot be effectively treated or stabilised
- Suffering from a disease or undergoing a form of treatment which can be expected to
influence immunological functions
- Suffering from a chronic, degenerative and/or inflammatory disease of the central
nervous system
- HIV-positivity (no special HIV test required for the purpose of the study)
- Suffering from a febrile disease
- History of vaccination against yellow fever and/or Japanese encephalitis
- Participation in another clinical trial
Age minimum:
6 Months
Age maximum:
47 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Encephalitis, Tick-Borne
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Intervention(s)
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Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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