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Simplifying the Rabies Pre-exposure Vaccinatio

Phase 1
Conditions
Rabies is a viral infection that affects the central nervous system. It causes encephalitis which is almost invariably fatal. Preventive vaccination alone implies no complete protection, but simplifies the post-exposure procedure considerably, as the immunological response comes much more rapid in case of a booster vaccination post-exposure. This lowers the risk of morbidity and mortality.
Therapeutic area: Diseases [C] - Virus Diseases [C02]
Registration Number
EUCTR2011-001612-62-BE
Lead Sponsor
Institute of Tropical Medicine Antwerp
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

»Willingness to provide written consent
»Age between 18 and 47 years
»Seronegative for rabies
»Belgian soldiers who are deployable and visit the Travel clinic in Brussels during their preparation phase before deployment OR military students at the schools of Belgian Defense are eligible in preparation of an overseas exercise or during the scheduled vaccination program at the end of their studies
»Prepared to follow the study schedule

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 480
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

»Subjects who have had rabies vaccination (complete or incomplete) in the past due to post-exposure prophylaxis.
»Subjects with a known allergy to one of the components of the vaccine.
»Immune depressed persons or intake of immunodepressant medication.
»Subjects who take mefloquine
»Planned deployment to overseas areas within 35 days.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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