One-visit Multi-site Intradermal Rabies Vaccination - Dose Finding
NCT ID: NCT02276625
Last Updated: 2014-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2014-10-31
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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A - ID
Intradermal administration. 20% dose in a single visit.
rabies vaccine
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B - ID
Intradermal administration. 40% dose in a single visit.
rabies vaccine
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C - ID
Intradermal administration. 60% dose in a single visit.
rabies vaccine
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D - IM
1x IM
rabies vaccine
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Interventions
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rabies vaccine
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Eligibility Criteria
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Inclusion Criteria
* Good health according to the investigator
* Willingness and ability to adhere to the study regimen
* Able to give informed consent
Exclusion Criteria
* Known or suspected allergy against any of the vaccine components
* History of unusual or severe reactions to any previous vaccination
* Immunocompromized state due to illness or medication
* Administration of plasma or blood products three months prior to inclusion in the study
* (hydroxy)chloroquine or mefloquine use
* History of any neurological disorder including epilepsy or febrile seizures
* Pregnancy or breastfeeding
* Any current infectious disease other than seasonal cold
* Bleeding disorders or use of anticoagulants
18 Years
50 Years
ALL
Yes
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Leo Visser, M, PhD
Role: PRINCIPAL_INVESTIGATOR
LUMC
Locations
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Leiden University Medical Center
Leiden, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R5
Identifier Type: -
Identifier Source: org_study_id
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