Safety and Immunogenicity Study of Rabies Vaccine and Japanese Encephalitis Vaccine Administered Together and/or Separately According to Different Schedules to Healthy Subjects

• Conditions: Safety and Immunogenicity 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; MedDRA version: 14.1Level: PTClassification code 10037742Term: RabiesSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10023123Term: Japanese encephalitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: HLTClassification code 10037743Term: Rabies viral infectionsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-005173-23-DE
• Lead Sponsor: ovartis Vaccines and Diagnostics GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-25
• Last Update Posted: 8 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 660

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.
4.Individuals who have access to a touch key telephone and are able to use the eDiary to record safety assessments as required by the protocol.

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified