EUCTR2011-005173-23-ATActive, not recruitingNot Applicable
A Phase III, Multicenter, Observer-blind, Safety and Immunogenicity Study of Rabies Vaccine and Japanese Encephalitis Vaccine Administered Concomitantly and/or Separately According to 1 of 2 Different Pre-exposure Prophylaxis Schedules to Healthy Adult Subjects
ovartis Vaccines and Diagnostics GmbH0 sites660 target enrollmentStarted: February 6, 2012Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 660
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Males and females between 18 and 65 years of age (inclusive)
- •2.Subjects who have given written consent after the nature of the study has been explained according to local regulatory requirements.
- •3.Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
- •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 660
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1.History of previous rabies/rabies immune globulin and/or JE immunization.
- •2.Any individuals with a contraindication or precaution against vaccination with Rabipur® or IXIARO® as highlighted in the package inserts of these products
- •3.Subjects currently receiving or planning to receive anti-malarial medications (e.g. Mefloquine) 14 days prior to Day 1 vaccination through Day 43.
Investigators
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