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Clinical Trials/EUCTR2011-005173-23-AT
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

Sponsor
ovartis Vaccines and Diagnostics GmbH

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